User Manual - Direct Healthcare
Contents
1. Operation Mattress Function Establishing Pressure Supine patient With the patient lying supine on their back face upwards select the soft medium or firm setting based on patient weight and comfort requirements You may also select the Dynamic or Static setting using the relevant buttons Before changing 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 If a hand 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 Audible Warning 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 support2. IFC 61000 4 8 typical commercial or hospital environment NOTE U is the mains voltage prior to application of the test level Technical Specification Declaration electromagnetic immunity for ME EQUIPMENT and ME SYSTEMS that are not LIFE SUPPORTING Guidance and manufacturer s declaration electromagnetic immunity The MAT SURESSE PUMP is intended for use in the electromagnetic environment specified below The customer or the user of the system should ensure that it is used in such an environment Immunity test IEC 60601 test level Compliance level Electromagnetic environment guidance Conducted RF Portable and mobile RF communications equipment IFC 61000 4 6 150 kHz to 80 MHz should be used no closer to any part of the CT515 including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Radiated RF 3V m 3V m A Recommended separation distance IEC 61000 4 3 80 MHz to 2 5 GHz d 1167VP d 1167VP 80 MHz to 800 MHz d 2 333 800 MHz to 2 5 GHz 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 meters 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
3. 60601 Compliance level Electromagnetic environment guidance test level Electrostatic discharge ESD 6 kV contact 6 kV contact Floors should be wood concrete or ceramic tile IEC 61000 4 2 8 KV air 8 kV air If floor are covered with synthetic material the relative humidity should be at least 30 Electrical fast transient burst 2 kV for power 2kV for power Mains power quality should be that of a typical IEC 61000 4 4 supply lines supply lines commercial or hospital environment Surge IEC 61000 4 5 1 kV line s to 1kV differential Mains power quality should be that of a typical line s mode commercial or hospital environment Voltage dips short lt 5 0 295 dip lt 5 0 gt 95 dip Mains power quality should be that of a typical interruptions and voltage in U for 0 5 cycle in U for 0 5 cycle commercial or hospital environment If the variations on power supply 40 U 60 dip 40 U 60 dip user of the Span system requires continued input lines U for 5 cycles in U for 5 cycles operation during power mains interruptions it 61000 4 11 70 0 30 dip 70 U 30 dip is recommended that the system be powered in U for 25 cycles inU_ for25cycles from an uninterruptible power supply or a lt 5 0 gt 95 dip lt 5 0 gt 95 dip battery in U for 5 sec in U for 5 sec Power frequency 50 2 Power frequency magnetic fields should be at magnetic field levels characteristic of a typical location in a
4. 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 2 Remove the Rapid Release Handle from the Control Unit 3 Place Control Unit and power cable on top of the Mattress and detach Mattress from the bed frame 4 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 4 Troubleshooting Warning Fault Cause Solution The Control Unit may not be attached to a power source or a fuse may need replacing Control Unit does not operate no display lights illuminate 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 nit 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 fuses is carried out accordanc
5. Manufacturer will provide circuit diagrams component part lists descriptions to assist to service personnel in parts repair A The mattress is treated as the applied part A Unplug the control unit from the mains power supply to disconnect the power Control Unit 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 power cord supplied with the system A Exposure of the electronic Control Unit to any liquid while it is 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 sho
6. 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 be a 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 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 Insert a 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 a new 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 7 Warranty Information This product is produced to perform in accordance with established specifications starting from the date the product is shipp
7. Dyna Form Air Suresse User Manual Direct Healthcare DIRECTHEALTHCARESERVICES CO UK Dyna Form K Air Suresse 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 Contents O 4 2 e 5 6 Unpacking SclMSPSCUON alee 6 AA 7 srar ae 7 Audible Warning FUNCTIONS c ccccccccsecsessessesssessecsesssseseecsecsssseceesessssassassassascessesessassaseaseessessesesseseeseesanseeseesessessesesansanas 8 ee 8 Removal amp Transport FUNCION 10 eanne r 11 VAG tee 13 6 MaintenaNCE ii dt 15 7 Warranty 16 8 Technical Specifications 8 1 Safety Precautions In General A Do not use this
8. 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 Audible Warning Mute and Lock Unlock buttons remain operational Press 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 peration Warning Function Ho The system has three different warning signals identified by illumination sequences he signals and corresponding Pressure Setting LED displays are illustrated below Display Warning Signal he red Warning 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 he audible warning can be silenced by pressing the Audible Warning Mute button We A High pressure The system cannot reach the set pressure within 8 minutes The system pressure is to high 00 ABC MN The system cannot reach the set pressure within 8 minutes Low pressure o 0 The system pressure 15 to low ABC MN Mains Failure gt Power unit has no power feed
9. Promise 150 9001 2008 EN ISO 13485 2012 Issue 2 Date September 2015 Sales Offices UK amp Europe Direct Healthcare Services Ltd 6 10 Withey Court Western Industrial Estate Lon y Llyn Caerphilly CF83 1BF UK T 44 0 845 459 9831 info directhealthcareservices co uk Asia Pacific Direct Healthcare Services PTY Ltd PO Box 562 Wembley Western Australia 6913 T 61 0 423 852 810 info directhealthcareservices com au
10. and to avoid bottoming out A It is important to return to the original pressure setting when the patient returns to the supine position 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 the Mattress may be required for emergency treatment or to decommission the system Firmly pull the Rapid Release CPR Tag from the side of the Mattress to rapidly deflate the entire system To re inflate the system after the Rapid Release CPR Tag 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 system The Air Suresse is a replacement mattress system Remove the standard foam hospital mattress before patient use Operation Transport Function 1 Before patient transport switch modes from alternating to static and wait for 10 15 minutes for cells to inflate to maximum pressure 2 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 hours as a transport feature
11. dure please use hygienic hand disinfection with an alcoholic skin disinfectant To protect 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 Suresse 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 hose
12. e with local legislation Mains failure Other see above plus gt Warning LED C Audible warning A W wy y Y O 9 PAS TIN ABC 1 Reset the warning turn off power and press the Audible Warning 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 Warning LED Pressure too low B Audible warning A 1 Reset the warning turn off power and press the Audible Warning 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 Warning Fault Cause Solution Warning LED Pressure too hig
13. ed 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 customer damage negligence and or misuse 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 on cover 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 8 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 Caution Consult accompanying documents Class ll equipment Manufacturer Serial number Type B applied part DISPOSAL Do not dispose of this product as unsorted municipal waste Collection of such waste separately for special treatment is necessar
14. equipment in the presence of flammable anaesthetics Explosions could result In line with MDA 2013 073 the manufacturer warns against the dangers of smoking in bed 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 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 A No special skills or training of the operator is required there is no restriction on location or 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 between the system and other device may occur If interference is suspected move equipment from sensitive devices or contact the manufacturer A Preventive inspection and calibration is not required A Do not modify this equipment without authorization of the manufacturer A
15. h 1 Reset the warning turn off power and press the Audible A Warning mute button Audible warning 2 Disconnect the air hoses to reduce pressure reconnect when pressure has decreased 3 Check for twists in the air hoses between Mattress and Control Unit 4 Switch on power ABC Other checks to consider as below Warning LED Alternating Mode Failure 1 Reset the warning turn off Power and press the Audible Any no alternation Warning Mute button 2 Disconnect the air hoses to reduce pressure reconnect Audible warnin i when pressure has decreased Warning LED Power down 1 Press the Audible Warning Mute button to silence the audible Any warning 2 Check the power cable is firmly plugged into the mains outlet and the Control Unit and check the mains power is switched on 3 Check the Control Unit fuse 1 AMP fuses can be released using a screwdriver to push and turn Audible warning Patient is sinking or The pressure may be set too 1 Increase the pressure setting by pressing up the Pressure bottoming out whilst lying low for the patient s weight arrow flat on the Mattress 2 To check effective system performance conduct a bottoming Replacement out test as described on page 8 A lf the problem is not resolved please contact Direct Healthcare or an authorised local distributor See contact information on cover 5 Cleaning Before the cleaning and disinfection proce
16. harged will last the life time of the product Buttons on the control panel adjust the three comfort level settings lt The Warning LED indicator and Audible Warning Mute completes the profile The visible and audible warning 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 wiring 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 Audible Warning will sound See picture on inside cover Installation Unpacking amp Inspection A Itis 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 back 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 3 Operation Control Unit Panel see inside cover A Power Button Turns system power on and off by pressing the Power button fo
17. nd disinfection solution to the 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 Allow to air dry before use Handle The exterior of the Handle can be periodically wiped using a cloth and 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 anaesthetic 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 6 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 unit
18. occur in the vicinity of equioment marked with the following symbol NOTE1 At80MHza NOTE2 These guidelines may not from structures objects a nd 800 MHz the higher frequency range applies apply in all situations Electromagnetic propagation is affected by absorption and reflection nd 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 If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the system b Over the frequency range 150kHz to 80Mk7 field strengths should be less than 3V m 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 SURESSE PUMP Alternating Control Unit The MAT SURESSE PUMP is intended fo
19. r at least two seconds B Warning LED A B amp C One of these red light flashes and an audible warning sounds to alert when Control Unit or Mattress Replacement pressure fails The warning has three different signals to indicate the cause of the failure see over The Audible Warning also sounds when power is switched off press Audible Warning Mute to silence C Audible Warning Mute Button Silences the audible warning on off Audible warning 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
20. r use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the system can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the system as recommended below according to the maximum output power of the communications equipment Rated maximum output Separation distance according to frequency of transmitter m power of transmitter W 150 KHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz d 1167 P d 1167VP d 2 3337 0 01 0 117 0117 0 233 01 0 369 0 369 0 738 1 1167 1167 2 333 10 3 689 3 689 7 379 100 11 667 11 667 23 333 For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters 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 NOTE1 At80 MHz 800 MHz the separation distance for the higher frequency range applies NOTE2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people 22 DYNA FORM AIR SURESSE DIRECTHEALTHCARESERVICES CO UK USER MANUAL DIRECTHEALTHCARESERVICES CO UK 23 Direct Healthcare Delivering the
21. s before sliding each cell out from the cell straps Swab 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 select an 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 lf 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 a
22. uld 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 A Do not position the system so that it is difficult to operate the disconnection device 2 Product Overview Alternating Mattress system see cover Dyna Form Air Suresse is an Alternating Mattress Replacement 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 15 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 Audible Warning sounds when pressure fails or power is interrupted Audible Warning Mute silence the Audible Warning for maximum of 20 minutes the Audible Warning resumes if cause of failure is not resolved The Audible Warning will sound for up to two hours following an interruption to power The Control Unit includes a back up power battery for the Audible Warning This battery is continuously re c
23. y Operating Instruction Y Dx gt 2E 0 Technical Specification Declaration electromagnetic emissions for all ME EQUIPMENT and ME SYSTEMS Guidance and manufacturer s declaration electromagnetic emission The MAT SURESSE PUMP is intended for use in the electromagnetic environment specified below The customer or the user of the system should ensure that it is used in such an environment Emission test Compliance Electromagnetic environment guidance RF emissions Group 1 The system uses RF energy only for its internal function CISPR 11 Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emission Class B The system is suitable for use in all establishments including CISPR 11 domestic establishments and those directly connected to the public low voltage power supply network that supplies Harmonic emissions Class A buildings used for domestic purposes IEC 61000 3 2 Voltage fluctuations flicker Complies emissions IEC 61000 3 3 Technical Specification Declaration electromagnetic immunity The customer or the user of the system should ensure tha Guidance and manufacturer s declaration electromagnetic immunity The MAT SURESSE PUMP is intended for use in the electromagnetic environment specified below it is used in such an environment Immunity test IEC
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