Hyper-Box
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1. Infected wounds Page 17 of 30 The Hyper Box Topical Wound Oxygen system is intended as adjunctive therapy to standard wound care for acute or chronic wounds The Hyper Box Topical Wound Oxygen controller regulates the humidified oxygen pressure and the duration of treatment inside the extremity chamber in accordance with the physician s orders The reusable chamber must be cleaned and sterilized between patients to alleviate any potential cross infection risks It is recommended to remove all bandages dressings creams and ointments from the wound prior to treatment Wounds should be cleaned and debrided if required per standard wound care protocols prior to commencing treatment with this device Recommended treatment durations are Out patient e 60 90 mins once a day In patient or home patient 3 hours once a day or 90 mins twice a day It is recommended that all infected wounds including those infected with antibiotic resistant strains such as MRSA be treated utilizing the institutions standard operating procedures in conjunction with the therapy Hyper Box User Manual Rev D 7 2009 P N G00102 7 5 Applying the therapy utilizing the Reusable Chamber 7 6 Aftercare Page 18 of 30 TopicglWound Set the desired therapy pressure and duration as prescribed by the physician as detailed in section 8 of this manual Insert the patient s limb through the Patient Ring making sure to stretch2. On Off Use the On Off switch to switch the device on or power down to the stand by mode Navigation Use the navigation button Up to scroll button UP up a menu Navigation Use the navigation button Down to button DOWN scroll down a menu Enter The Enter button is used to move between menu levels and to acknowledge alarms Page 19 of 30 Hyper Box User Manual Rev D 7 2009 P N G00102 TopicglWound 8 2 Personnel Caution The Hyper Box Topical Wound Oxygen system should only be operated by personnel with suitable trainina 8 3 Switching the Check that all cables and tubes are correctly installed device on off Start the device by pressing the On Off button 8 4 The start screen When the Hyper Box is switched on using the On Off button the welcome screen appears After two seconds the chamber selection screen is displayed 8 5 Reusable The preset therapy pressure and duration time is now Chamber displayed Selected Toggle through to the Start Stop display by pressing the navigation buttons Down Press Enter to commence the therapy While the therapy pressing the Enter key will cause the therapy to stop 8 6 Therapy After completion of the therapy the message Therapy Complete screen Complete is displayed Page 20 of 30 Hyper Box User Manual Rev D 7 2009 P N G00102 8 7 The monitoring and settings menu 8 8 Changing Settings for therapy Pressure and Duration 8 9 Running hours P
3. Pressure Automatic stand by mode Operating time Operating pressure Check seals 5 10 L min 100 oxygen 0 60 Psi 0 4 Bar 0 50 mb Therapy pressure too high Internal temperature too high Therapy complete WxLxHof Reusable Hyper Box Chamber WxLx Hof Single Use Hyper Box Chamber W x Lx H of Controller Units Total weight of Reusable Hyper Box System Total weight of Single Use Hyper Box System Operational Temperature 14x14 x 22 inches 35 x 35 x 56 cm 12x14 x 20 inches 30 x 35 x 51 cm 8x13 x3 inches 20 x 33 x 8 cm 48 lbs 21 kg 15 Ibs 7 kg 50 to 104 F 10 to 40 C Operational Humidity lt 80 RH Storage and transport 14 to 140 F 10 to conditions 60 C at 5 to 95 RH 115 VAC 50z Input voltage 230 VAC 50 60Hz Power consumption lt 25VA Fuse Rating Hyper Box User Manual Rev D 7 2009 1A slow blow P N G00102 4 3 Compliance and Page 7 of 30 approvals TopicglWound CE 0050 The Hyper Box Topical Wound Oxygen system complies with the requirements of directive 93 42 EEC concerning Medical Devices and therefore bears the CE mark The Hyper Box Topical Wound Oxygen system is classified as protection class I Type BF steady state The Hyper Box Topical Wound Oxygen system complies with the following International standards IEC 60601 1 Electrical Safety IEC 60601 1 2 Electromagnetic Compatibility CAN CSA C22 2 No 0 M91 General
4. Requirements Canadian Electrical Code Part II CSA Std C22 2 No 0 4 M2004 Bonding and Grounding of Electrical Equipment Protective Grounding CAN CSA C22 2 No 601 1 M90 Medical Electrical Equipment Part 1 General Requirements for Safety CAN CSA C22 2 No 601 1S1 94 Supplement No 1 94 to CAN CSA C22 2 No 601 1 M90 Medical Electrical Equipment Part 1 General Requirements for Safety CSA 601 1 Amendment 2 1998 UL Std No 0601 1 1 Medical Electrical Equipment Part 1 General Requirements for Safety Hyper Box User Manual Rev D 7 2009 P N G00102 4 4 Manufacturer s declaration Guidance and manufacturer s declaration electromagnetic emissions The Hyper Box with O2 controller is intended for use in the electromagnetic environment specified below The customer or the user of the Hyper Box with O2 controller should assure that it is used in such an environment Emissionstest_ Compliance Ss Electromagnetic environment guidance RF emissions The Hyper Box with O2 controller uses RF energy CISPR 11 only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment CISPR 11 in all establishments including domestic Harmonic emissions Class A establishments and those directly connected to the IEC 61000 3 3 Guidance and manufacturer s declaration electromagnetic immunity The Hyper Box with O2 controller is intended for use
5. can find the AC power connection on the right side of the Hyper Box Topical Wound Oxygen controller The Topical Wound Oxygen Hyper Box should be connected to a grounded 115 VAC 60 Hz or 230 VAC 50 60 Hz mains outlet Only use the grounded three pin power cord provided with the device Connect the DISS oxygen hose to the DISS connector located on the right hand side of the controller unit DISS O2 Connector Hyper Box User Manual Rev D 7 2009 P N G00102 6 6 Connecting the Oxygen hose toa Liquid Oxygen LOX system or a High Pressure Cylinder TopicglWound Use only in a well ventilated room Inadequate room ventilation or Inappropriate venting of oxygen from the Hyper Box Topical Wound Oxygen System could lead to fire or explosion Never smoke or use a naked flame in the presence of oxygen If utilizing a Liquid Oxygen System LOX with the device follow all rules pertaining to the safe handling of liquid oxygen as detailed in Appendix B Only use clean oil free DISS hoses and connections to connect the Oxygen Source to the Hyper Box Topical Wound Oxygen controller Bottle Installation instructions 1 Connect the alternate end of the DISS oxygen hose to the regulator flowmeter outlet on the oxygen cylinder or LOX system Slowly open the main valve on the oxygen cylinder or LOX system Set the flowmeter to 10 Ipm Page 15 of 30 Hyper Box User Manual Rev D 7 20
6. in the electromagnetic environment specified below The customer or the user of the Hyper Box with O2 controller should assure that it is used in such an environment Immunity tests IEC 60601 Compliance level Electromagnetic environment guidance Test level Electrostatic discharge 6 kV contact 6 kV contact Floors should be wood concrete or ceramic tile If ESD floors are covered with synthetic material the 8 kV air 8 kV air relative humidity should be at least 30 IEC 61000 4 2 Electrical fast 2 kV for power 2 kV for power supply Mains power quality should be that of a typical transient burst supply lines lines commercial or hospital environment IEC 61000 4 4 1 kV for 1 kV for input output input output lines lines Surge 1 kV differential 1 kV differential mode Mains power quality should be that of a typical mode commercial or hospital environment IEC 61000 4 5 2 kV common mode 2 kV common mode Voltage dips short lt 5 Ur lt 5 Ur Mains power quality should be that of a typical interruptions and voltage gt 95 dip in U7 gt 95 dip in U7 commercial or hospital environment variations on power supply for 0 5 cycle for 0 5 cycle input lines If the user of the Hyper Box with O2 controller 40 Ur 40 Ur requires continued operation during power mains IEC 61000 4 11 60 dip in Ur 60 dip in Ur interruptions it is recommended that the Hyper Box for 5 cycles for 5 c
7. is met The alarm ends as soon as the alarm condition no longer exists The alarm can be silenced for two minutes by pressing the Enter button If the alarm condition is still present once these two minutes have elapsed the alarm will resume Alarm condition fulfilled high pressing the Enter button Alarm condition not fulfilled High priority alarm er ee conditions Alarm condition Reset Criteria Reaction of device High Pressure alarm Therapy Pressure Therapy Pressure Switch to stand by exceeds set alarm within limits and vents value chamber to atmosphere 8 10 2 Warnings N Warning All alarms should be responded to in timely manner Ignoring any alarm may interfere with the functionality of the device and could result in patient injury Page 22 of 30 Hyper Box User Manual Rev D 7 2009 P N G00102 TopicglWound Medium priority alarm conditions Alarm condition Reset Criteria Reaction of Corrective action device Check seal The therapy pressure Check all patient Controller in the chamber has not connections tubes vents been reached within 90 and cuff for leakage chamber to seconds atmosphere Informational Alarm condition Reset Criteria Reaction of Messages Corrective action device Therapy complete Preset therapy Once the Enter None duration has elapsed button has been pressed the settings screen appears 8 10 3 Exiting the alarm Once the alarm condition is no longer active the current menu setti
8. rating in 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 Ko NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people Fixed 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 access the electromagnetic environment due to fixed RF transmitters and electromagnetic site survey should be considered If the measured field strength in the location in which the Hyper Box with O2 controller is used exceeds the applicable RF compliance level above the Hyper Box with O2 controller should b observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the Hyper Box with O2 controller Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m Page 9 of 30 H
9. 09 P N G00102 6 7 Connecting the Oxygen hose to the hospital s piped medical gas supply 6 8 Setting up the Humidifier 6 9 Connecting the patient sleeves on the Reusable chamber Page 16 of 30 TopicglWound Installation instructions 1 Connect the alternate end of the DISS oxygen hose to the DISS oxygen outlet of the flowmeter connected to the piped wall supply 2 Set the flowmeter to 10 Ipm Take a new Single Use humidifier jar from the Hyper Box Topical Wound Oxygen system and fill it to full with sterile demineralised distilled water Then screw it to the humidifier jar connector Caution The use of fluids other than sterile distilled water for humidfication may cause damage to the Hyperbox svstem After each treatment dispose of the water and jar utilizing standard hospital procedures Remove the patient ring from the Reusable Hyper Box chamber Select the correct sleeve size for the patient as detailed below 4 Sleeve Patient Ring Sleeve Limb Size Paediatric sleeve lt Q inches Small sleeve gt 9 lt 10 Inches Medium sleeve gt 10 lt 13 5 Inches Large sleeve gt 13 5 lt 15 Inches X Large sleeve gt 15 Inches Stretch the larger end of the sleeve over the patient inlet ring Hyper Box User Manual Rev D 7 2009 P N G00102 TopicgiWeund 7 Applying the Therapy 7 1 7 2 7 3 7 4 Basic description Preparing the wound Recommended Treatment duration
10. 7 The monitoring and settings menu 21 8 8 Changing Settings for therapy Pressure and Duration 21 8 9 Running hours 21 8 10 The alarm screen 22 8 10 1 High Priority Alarms 22 8 10 2 Warnings 22 9 Care and Maintenance 24 9 1 Personnel 24 Page 2 of 30 Hyper Box User Manual Rev D 7 2009 P N G00102 9 2 Guidelines for care and maintenance 9 3 Cleaning and Disinfection 10 Accessories and Spare Parts 10 1 Address for orders 10 2 Accessories and spare parts 11 Disposal 12 Appendix A Abbreviations and Glossary 13 Appendix B Liquid Oxygen Safety Page 3 of 30 Hyper Box User Manual Rev D 7 2009 TopicglWound 24 25 26 26 26 27 28 30 P N G00102 TopicgiWeund Application This documentation applies to the product described as e Hyper Box Topical Wound Oxygen TWO System You will find this description on the nameplate on the side of the device Firmware version This documentation applies to the firmware version SW Version 1 0 or greater Second edition of this user manual Rev C January 2008 Subject to technical modification without prior warning Key to symbols used in this manual Keys Hyper Box labels and information Keys such as Enter Hyper Box Labels in the display such as Air IN and information in the display such as Change Settings are shown in bold italic type Page 4 of 30 Hyper Box User Manual Rev D 7 2009 P N G00102 TopicgiWeund 3 Intended Us
11. Topicg Wound Hyper Box Topical Wound Oxygen System User Manual Page 1 of 30 Hyper Box User Manual Rev D 7 2009 P N G00102 TopicglWound 1 Table of Contents 1 Table of Contents 2 2 Preface 4 3 Intended Use 5 4 Technical Data 6 4 1 Configuration 6 4 2 Power supply 6 4 3 Compliance and approvals 7 4 4 Manufacturer s declaration 8 4 5 Device labels and symbols 11 5 Safety Instructions 13 5 1 Symbol for warnings cautions and notes 13 5 2 Personnel 13 5 3 Basic safety information and warnings 13 6 Preparing for Use 14 6 1 Personnel 14 6 2 Items supplied with the Hyper Box Topical Wound Oxygen Chamber and Controller system 14 6 3 Set up and assembly 14 6 4 Connecting the Mains supply 14 6 5 Connecting the Oxygen hose to the controller unit 14 6 6 Connecting the O2 hose to a Liquid Oxygen system or High Pressure Cylinder 15 6 7 Connecting the Oxygen hose to the hospital s piped medical gas supply 16 6 8 Setting up the Humidifier 16 6 9 Connecting the patient sleeves on the Reusable chamber 16 7 Applying the Therapy 17 7 1 Basic description 17 7 2 Preparing the wound 17 7 3 Recommended Treatment duration 17 7 4 Infected wounds 17 7 5 Applying the therapy utilizing the Reusable Chamber 18 7 6 Aftercare 18 8 Controller Unit Operation 19 8 1 Description of operating controls 19 8 2 Personnel 20 8 3 Switching the device on off 20 8 4 The start screen 20 8 5 Reusable Chamber Selected 20 8 6 Therapy Complete screen 20 8
12. age 21 of 30 TopicalWound The monitoring and settings menu displays a number of selectable or monitored parameters These include 1 The therapy pressure in mb 2 The therapy duration in minutes 3 The devices running hours 4 Various alarm messages You can scroll through these menus or select another display value by pressing the navigation buttons Up and Down You can set the therapy pressure and duration as prescribed by the physician as follows Start the device by pressing the Power button The welcome screen appears After two seconds the chamber selection screen is displayed Press the Up and Down arrow together to progress into the settings menu Use the Up and Down arrow to adjust prescribed therapy pressure and then press Enter Use the Up and Down arrow to adjust prescribed therapy duration and then press Enter These values are now stored in memory and will be retained until changed using this process The running hours can be viewed by using the Up and Down arrow to toggle to the running hours display DOF Controller Some in Monnallseiral Hyper Box User Manual Rev D 7 2009 P N G00102 TopicglWound 8 10 The alarm screen If an alarm is triggered a corresponding message will appear in the display Alarms are divided into two priority classes e High priority alarm e Medium priority alarm 8 10 1 High Priority A high priority alarm is generated when a certain alarm Alarms condition
13. anual Rev D 7 2009 P N G00102 4 5 Device labels and The following labels and symbols can be found on symbols the Hyper Box Topical Wound Oxygen system 230V 50 60Hz SN YYYY A S amp C 0050 A Power switch On Off Navigation and value setting button Up Navigation and value setting button Down Enter button change menu level apply changed value and acknowledge of alarms Mains input 115V 60Hz Mains input 230V 50 60Hz Serial number Warning observe accompanying documents No smoking Do not use oil or grease CE number Applied part type BF according to EN 60601 1 CSA amp UL Approval Page 11 of 30 Hyper Box User Manual Rev D 7 2009 P N G00102 TopicgiWeund Dispose of Safely Page 12 of 30 Hyper Box User Manual Rev D 7 2009 P N G00102 TopicgiWeund 5 Safety Instructions 5 1 Symbol for This triangular hazard symbol is used to draw your warnings cautions attention specifically to the remaining dangers and notes associated with proper use and to emphasise important technical requirements Cautions or Instructions to prevent potential injury or damage 5 2 Personnel Caution The Hyper Box Topical Wound Oxygen system should only be operated by personnel with suitable trainina 5 3 Basic safety information and warnings Warning The Hyper Box Topical Wound Oxygen system should only be used with medical grade oxygen If util
14. components in the device carry AC mains voltage Before you open the device always disconnect the mains plug risk of electrocution Page 27 of 30 Hyper Box User Manual Rev D 7 2009 P N G00102 TopicglWound 12 Appendix A Abbreviations and Glossary A A Ampere AC Alternating Current AT Ampere Slow Blow fuse B bar 1 bar 14 50 psi C C Degrees Celsius Converting Celsius C to Fahrenheit F F 9 C 5 32 D dBA Decibels measured with a filter DC Direct Current F F Degrees Fahrenheit Converting Fahrenheit F to Celsius C C F 32 5 9 H Hz Hertz 1Hz 1s IP Safety class according to ISO standards L Litres lbs Pounds Ipm Litres per minute of flow M Max max Maximum Min Minute min Minimum mmHG Millimetres of mercury pressure P psi Pressure pounds per square inch 1 bar 14 50 psi R RH Relative humidity T TF Technical fault V V Volt Page 28 of 30 Hyper Box User Manual Rev D 7 2009 P N G00102 TopicglWound VA Apparent power of device VAC Volt Alternating Current VDC Volt Direct Current Page 29 of 30 Hyper Box User Manual Rev D 7 2009 P N G00102 Page 30 of 30 TopicgiWeund 13 Appendix B Liquid Oxygen Safety PATIENT USER TRAINING CARD USE OF MEDICAL LIQUID OXYGEN VESSELS IN THE HOME 1 Read the User Instruction Manual carefully before operating your liquid oxygen vessels and equipmen Pay special attention to in
15. control valve anticlockwise wily gt Open 11 When transfilling the portable unit never leave it unattended until the unitis full If the unit will not disconnect easily never use force to remove it Wait a few moments to allow it to thaw and then try again 14 Select zero on the oxygen flow control valve after use Keep closed when the liquid oxygen vessel is not in use NUZ Ss Close Hyper Box User Manual Rev D 7 2009 3 Only use your liquid oxygen vessels and equipment in a well ventilated area Keep internal doors open whilst your oxygen vessels are in use 6 Do not use oils or grease with your liquid oxygen vessels or equipment Ensure that your hands are clean when using the vessels Only use authorised creams and moisturisers when using your medical oxygen 9 Set the flow control valve to the flowrate prescribed by your Doctor Check for any leaks on the tubing connection after selecting the into contact with correct flowrate your skin This could cause a serious burn Immerse affected parts in tepid water if you receive a cold burn fails for any reason call unless specifically instructed by your Service Provider 12 Never touch any cold parts on either vessel or allow liquid oxygen to come If either liquid oxygen vessel your Service Provider immediately Never try and repair any fault P N G00102
16. e Page 5 of 30 The Hyper Box Topical Wound Oxygen System is intended to be used for the treatment of acute and chronic wounds such as o Skin ulcerations due to diabetes venous stasis post surgical infections and gangrenous lesions decubitus ulcers amputations infected stumps skin grafts burns frostbite 00000 The Hyper Box Topical Wound Oxygen controller regulates the oxygen pressure and the duration of treatment inside the extremity chamber in accordance with the physician s orders Warning Inadequate cleaning and disinfection or sterilization of the Hyper Box Topical Wound Oxygen system after use may lead to transmission of infectious disease Inadequate room ventilation or Inappropriate venting of oxygen from the Hyper Box Topical Wound Oxygen System could lead to fire or explosion Never smoke or use a naked flame in the presence of oxygen Do not use in the presence of acute Caution Federal law restricts this device to sale by or on the order of a physician The Hyper Box Topical Wound Oxygen System should be operated by trained personnel under the direction of a qualified medical practitioner Hyper Box User Manual Rev D 7 2009 P N G00102 TopicgiWeund 4 Technical Data 4 1 Configuration 4 1 1 Pneumatics Special functions Monitoring Alarms warnings Physical data 4 1 6 Rating 4 2 Power supply Page 6 of 30 Input flow Input Pressure Therapy
17. formation where the hazard symbol is shown 4 Never place your oxygen vessels near curtains or cover them with clothing as this will restrict air circulation Materials become oxygen enriched if any leak occurs with no ventilation Never use or carry the portable oxygen vessel under any clothing 7 Attach the oxygen tubing to the outlet connector on the liquid oxygen vessel Ensure that the length of the tubing does not exceed 15 metres 10 Check for flow by placing the end of the tubing in a glass of water and watch for bubbles If no bubbles appear check a flow has been selected and there are no leaks If a flow is still not evident contact your Service Provider 13 Use only a clean damp cloth to clean your liquid oxygen vessels or any associated equipment Only use mild non abrasive cleaning materials Allow the liquid oxygen vessels to dry after wiping down 2 Materials burn much more vigorously in oxygen than air Never smoke or let someone else smoke near you whilst using your oxygen equipment Do not use your oxygen vessels near open fires or naked flames 5 Follow the advice Your Service Provider has given you where to safely store and use your liquid oxygen vessel Use and store your liquid oxygen base unit upright Use the portable unit only as shown in the Instruction Manual 8 To turn on your liquid oxygen vessel turn the oxygen flow
18. izing a Liquid Oxygen System LOX with the device follow all rules pertaining to the safe handling of liquid oxygen as detailed in Appendix B Only use clean oil free DISS hoses and connections to connect the Oxygen Source to the Hyper Box Topical Wound Oxygen controller Inadequate room ventilation or Inappropriate venting of oxygen from the Hyper Box Topical Wound Oxygen System could lead to fire or explosion Never smoke or use a naked flame in the presence of oxygen To sterilize the Hyper Box Topical Wound Oxygen Reusable Chamber or Controller Use only the specified cleaners detailed in section 11 Care and Maintenance of this manual Page 13 of 30 Hyper Box User Manual Rev D 7 2009 P N G00102 6 1 6 2 6 3 6 4 6 4 1 Personnel Items supplied with the Hyper Box Topical Wound Oxygen Reusable Chamber and Controller system Set up and assembly Connecting the Mains supply Input voltage 6 4 2 Mains power cord 6 5 Connecting the Oxygen hose to the controller unit Page 14 of 30 TopicgiWeund 6 Preparing for Use Caution The Hyper Box Topical Wound Oxygen system should only be operated by personnel with suitable trainina Reusable Chamber and Controller DISS Oxygen Hose Power cord User manual The set up and assembly is the same when utilizing either the Reusable or Single Use Chamber with the Controller unit except for steps 6 10 and 6 11 You
19. ler should be cleaned and disinfected after every use with an effective high level disinfectant Even antibiotic resistant organisms such as MRSA are effectively destroyed by the high level disinfectants listed below The sleeves on the reusable chamber are single patient use and should be replaced between patients Clean and Disinfect all internal and external surfaces of the reusable chamber and the external surfaces of the controller including gas connections hoses and mains power cord The following high level cleaner disinfectants or equivalents are recommended for this purpose Alpha Guard GF Dr Deppe Laborities GmbH Germany T36 Disinfectant Alda Pharmaceuticals Corp Canada Professional AMPHYL Disinfectant Cleaner Reckitt Benckiser Inc USA AOTI Ltd Qualtech House Parkmore Business Park West Galway Ireland AOTI Ltd Qualtech House Parkmore Business Park West Galway Ireland service aotinc net Hyper Box User Manual Rev D 7 2009 P N G00102 TopicglWound 10 Accessories and Spare Parts 10 1 Address for adar AOTI Ltd Qualtech House Parkmore Business Park West Galway Ireland sales aotinc net 10 2 Accessories and Article Ordernumber spare parts Hyper Box System 230 VAC G00001 Hyper Box System 115 VAC G00002 Hyper Box Reusable G00004 Chamber Alpha Guard G00005 disinfectant cleaner bottle Alpha Guard G00131 disinfectant cleaner case 12 Sleeves Single Use Paediat
20. ngs screen returns to the display Page 23 of 30 Hyper Box User Manual Rev D 7 2009 P N G00102 9 1 Personnel 9 2 Guidelines for care and maintenance Page 24 of 30 TopicglWound 9 Care and Maintenance Caution The Hyper Box Topical Wound Oxygen system should only be operated and maintained by personnel with suitable training To ensure the safe and effective functionality of the Topical Wound Oxygen Hyper Box it is important that the device is cleaned and maintained according to these instructions Only use spare parts and accessories recommended by the manufacturer Caution Guidelines and maintenance instructions provided by the manufacturer should be followed This is particularly important for the cleaning and sterilization of reusable products Inadequate cleaning and disinfection or sterilization of the Hyper Box Topical Wound Oxygen system after use may lead to transmission of infectious disease Alternative cleaning disinfectant substances to those recommended may cause damage to the acrylic material of the reusable Hyper Box chamber Always observe the manufacturers instructions for man far tha AnlnAannina Aiainfantant n hntannn Hyper Box User Manual Rev D 7 2009 P N G00102 9 3 Cleaning and Disinfection 9 3 1 Manufacturer s address 9 3 2 Technical support service Page 25 of 30 TopicglWound The surfaces of the Hyper Box Reusable chamber and the control
21. ric sleeve G00006 Small sleeve G00007 Medium sleeve G00008 Large sleeve G00009 X Large sleeve G00010 Sleeves Reusable Paediatric sleeve G0001 1 Small sleeve G00012 Medium sleeve G00013 Large sleeve G00014 X Large sleeve G00015 Chamber door patient G00016 Chamber door closed G00017 Humidifier Jar Kit G00021 Oxygen Sup Hose DISS DISS US G00167 Oxygen Sup Hose DISS DISS G00059 Page 26 of 30 Hyper Box User Manual Rev D 7 2009 P N G00102 11 Disposal TopicglWound The operator is responsible for the disposal of the device The operator must either Deliver the device free of charge and duty paid to the manufacturer for disposal or Surrender the device to a licensed private or public collection company or Competently recycle the parts dispose of them properly Where an operator chooses to dispose of the device himself the disposal regulations are specified for each country and laid down in the appropriate laws and regulations Please consult the responsible authorities for instructions on what is required With this in mind all waste is to be recycled or disposed of e Without any risk to human health Without employing procedures or methods which cause damage to the environment in particular water air earth flora and fauna Without causing any noise or odour nuisance Without detriment to the surroundings or landscape Caution During self disposal please note that some of the electronic
22. the sleeve such that it does not come in contact with the wound Position the limb in the chamber and close all three red clamps Check that the side access door is completely closed When the Hyper Box is switched on using the Power button the welcome screen appears After two seconds an information screen is displayed followed two seconds later by the first monitoring menu screen time and pressure The monitoring and settings menu displays specific Hyper Box values Toggle through to the Start Stop display by pressing the navigation buttons Down Select Start by pressing the enter key on the controller unit The therapy will now be applied to the patient per the physician s orders The therapy will automatically stop once the set treatment duration has completed Remove the Patient Ring from the chamber and the patient s limb from the sleeve After treatment the wound should be dressed utilizing the desired dressings as recommended by the clinician and following standard wound care procedures Hyper Box User Manual Rev D 7 2009 P N G00102 TopicglWound 8 Controller Unit Operation 8 1 Description of _ operating d l controls A HYPER BOX Display Field Too Wound A Display Field The display field provides information on the monitoring values for the Topical Wound Oxygen Hyper Box and is used to enter setting values LED The LED provides a visual alarm
23. ycles with O2 controller be powered from an uninterruptible power supply or a battery 70 Ur 70 Ur 30 dip in Ur 30 dip in U7 for 25 cycles for 25 cycles lt 5 Ur lt 5 Ur gt 95 dip in Us gt 95 dip in Ur for 5 secs for 5 secs Power frequency Power frequency magnetic fields should be at levels 50 60Hz magnetic field characteristic of a typical location in a typical IEC 61000 4 8 commercial or hospital environment NOTE Ur is the AC mains voltage prior to application of the test level Page 8 of 30 Hyper Box User Manual Rev D 7 2009 P N G00102 opie Wound Guidance and manufacturer s declaration electromagnetic immunity The Hyper Box with O2 controller is intended for use in the electromagnetic environment specified below The customer or the user of the Hyper Box with O2 controller should assure that it is used in such an environment Immunity tests IEC 60601 Compliance level Electromagnetic environment guidance Test level Portable and mobile RF communications equipment should be used no closer to any part of the Hyper Box with O2 controller including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance Conducted RF d 1 2 x root P IEC 61000 4 6 Radiated RF d 1 2 x root P 80 MHz to 800 MHz IEC 61000 4 3 d 2 3 x root P 800 MHz to 2 5 GHz Where P is the maximum output power
24. yper Box User Manual Rev D 7 2009 P N G00102 opie Wound Recommended separation distances between portable and mobile RF communications equipment and the Hyper Box with O2 controller The Hyper Box with O2 controller is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the Hyper Box with O2 controller can help prevent electromagnet interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the Hyper Box with O2 controller as recommended below according to the maximum output power of the communications equipment heen distance according to frequency of transmitter Rated maximum output ie of transmitter P isp kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz d 1 2 x root P d 1 2 x root P 2 3 x root P transmitters rated at a maximum output power not listed above the recommended separation distance din metres m can be calculated using the equation applicable to the frequency of the transmitter P is the maximum output power rating of the transmitter in watts W as declared by the transmitter manufacturer NOTE 1 At 80 MHz and 800 MHz the separation distance fort he higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people Page 10 of 30 Hyper Box User M
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