Amoul D-Tiger AII6000A, User Manual

Page 1: ...1 文件编号 H 1 601 00024 打印要求 彩色 黑白 AII6000A USER MANUAL 参 考 资 料 文件编号 说明 修 订 记 录 版本 ECR PCN TCN 更 改 内 容 制 订 批准日期 A3 0 ECR20180 108 更新地址 电话传真号码 苑振家 发放部门 生产部 采购部 质量部 市场部 研发部 存档方式 电子文档 纸文档 其它 制 订 审 核 批 准 日 期 日 期 日 期 2018 1 18 2018 1 18 2018 1 18 ...

Page 2: ...D Tiger AII6000A USER MANUAL Instructions and Safety Considerations of Ambulanc Emergency Ventilator FILE NO H 1 601 00024 VERSION A3 0 ISSUE DATE 2018 1 18 ...

Page 3: ...d only for editorial purposes without the intention of improperly using them They are the property of their respective owners Responsibility Statement on the Manufacturer Party Contents of this manual are subject to changes without prior notice All information contained in this manual is believed to be correct Ambulanc shall not be liable for errors contained herein nor for incidental or consequen...

Page 4: ...e or man made failure Malfunction or damage caused by unstable or out of range power input Malfunction or damage caused by force majeure such as fire and earthquake Malfunction or damage caused by improper operation or repair by unqualified or unauthorized service people Malfunction of the instrument or part whose serial number is not legible enough Others not caused by instrument or part itself S...

Page 5: ...g Telephone 49 40 2513175 Fax 49 40 255726 Preface Manual Purpose This manual contains the instructions necessary to operate the product safely and in accordance with its function and intended use Observance of this manual is a prerequisite for proper product performance and correct operation and ensures patient and operator safety This manual is based on the maximum configuration and therefore so...

Page 6: ...ion of oxygen content remaining operating time 22 5 10 Alternative ventilation procedures 23 6 Hygienic preparation 24 6 1 AII6000A 24 6 2 Patient valve 24 6 3 Ventilation hose 24 6 4 Masks 25 6 5 Fittings 25 6 6 Cleaning and disinfection procedure 25 7 Functional checks 27 7 1 Intervals 27 7 2 Checking for leaks in the system 28 7 3 Checking the patient valve 28 7 4 Checking the alarm systems 29 ...

Page 7: ...QUIPMENT and SYSTEMS 42 14 2Guidance and manufacturer s declaration electromagnetic immunity for all EQUIPMENT and SYSTEMS 43 14 3 Guidance and manufacturer s declaration electromagnetic immunity 44 14 4 Recommended separation distances between portable and mobile RF communications equipment and the EQUIPMENT or SYSTEM 46 ...

Page 8: ...switch B AII6000A connections 10 Pressurized gas connection 11 Product label 12 Battery compartment 13 Speakers 14 Pressure gauge hose connection 15 Fresh air intakes 16 Outlets C AII6000A device combinations 17 Masks 18 Patient valves 19 Pressure pipeline 20 Ventilation hose Symbol Meaning Emergency ventilation mode Toddler Emergency ventilation mode Child Emergency ventilation mode Adult IPPV wa...

Page 9: ...H 1 601 00024 A3 0 2 46 13 12 17 19 20 18 2 1 4 6 7 8 9 3 5 10 16 14 15 11 ...

Page 10: ...aximum ventilation pressure Pmax is not exceeded Permits respiration controlled oxygen inhalation in Demand mode 2 2 Ventilation function AII6000A operates within a pressure range of 2 7 to 6 bar and at a flow rate of not less than 70l min O2 It has a built in power pack It uses high pressure medicinal grade oxygen An external pressure reducer brings this down to the required operating pressure Th...

Page 11: ...tient valve The gas for inspiration is channeled into the patient s airways through the patient valve The valve is designed to enable spontaneous breathing in the event of failure of the AII6000A When connecting the patient valve take care to ensure that the direction of respiratory gas flow is correct see arrow 1 Outlet Φ30mm Convex cone Interface 2 Intake Φ15mm 20mm Coaxial Interface 3 Patients ...

Page 12: ...device has an audio response facility that can be switched on for user guidance especially for users who have little practice If audio response is not required a key combination can be used to switch it off See 5 8 Audio responses for user guidance ...

Page 13: ...A for the described purpose only See 2 1 Uses Warning Do not use the AII6000A in toxic environments or where there is a risk of explosion AII6000A is not suitable for hyperbaric use pressure chamber Do not use AII6000A with flammable anesthetics A back up ventilator should always be available in case of technical failure Before starting to work with AII6000A you must understand how to operate it T...

Page 14: ...xplosive reactions can occur if high pressure oxygen comes into contact with flammable substances fat oil alcohol etc Keep the equipment and all screw connections absolutely free from oil and grease Always wash your hands before starting to work on the oxygen supply Smoking and open flames are strictly prohibited in the vicinity of all fittings containing or transporting oxygen During assembly and...

Page 15: ...d prolonged exposure to direct sunlight as this can make them brittle and friable Adjustable knob The effective adjustable area of the knob is situated in the colorized scale of operation panel only the yellow orange brown green and white area on above figure and other region is strictly forbidden to access Warning It is strictly forbidden turning the knob into non operating area which is indicate...

Page 16: ...3 0 9 46 the indicating on the knob is aligned with the lower left edge of yellow colorized scale If not the device may exist problem please stop using and contact the manufacturer or the Ambulanc authorized personnel ...

Page 17: ...eactions if they come into contact with high pressure oxygen Never use wrenches or similar tools to tighten or loosen the screw connections Removing the empty cylinder Close the valve of the oxygen cylinder Switch on AII6000A with ON OFF switch 9 This exhausts any residual oxygen and depressurizes the ventilator Wait until the pressure gauge on the pressure reducer shows an oxygen content of zero ...

Page 18: ...his has not yet been done 4 2 Ventilation hose 1 Slide the pressure gauge hose onto connection 14 2 Slide the ventilation hose onto connection 15 Make sure that this does not cause any kinks in the pressure gauge hose already connected If necessary turn the ventilation hose while sliding on as appropriate Caution Always grasp the ventilation hose and pressure gauge hose by their end only position ...

Page 19: ...e hose Warning Please use the ventilation hose which is supplied by the manufacturer Ambulanc otherwise Ambulanc is not responsible for any adverse effect on the product performance If you are using the disposable patient ventilation hose please discard it after using 4 3 Wall mounting set A wall mounting set is available for permanent fixing e g on a vertical surface inside a vehicle Please refer...

Page 20: ...g Check power alarm status Check Respiratory Valve for patients Check trigger pressure Check the stenosis alarm see 7 4 Checking the alarm systems Check the disconnection alarm see 7 4 Checking the alarm systems Check the drop in O2 pressure alarm see 7 4 Checking the alarm systems ...

Page 21: ...llowing if not then there is no voice prompt for operation During this test the four LEDs in alarm panel 3 flash on and off and a short alarm tone sounds Warning If an error is found during self test the individual LEDs of 50 55 and 60 in ventilation pressure gauge2 will keep flashing approx 5 seconds then the machine will enter into working state but no oxygen supply The device must not be used f...

Page 22: ...light up in active mode Recommended maximum ventilation pressure Mask ventilation Intubations 20 mbar 45 mbar Audio response enabled Mask ventilation mode Tilt the head back secure mask tightly Audio response enabled Tube ventilation mode Ventilation pressure limit 45 mbar If the maximum level is reached e g in cases where compliance is inadequate AII6000A sets off a stenosis alarm NOTE The mask t...

Page 23: ...tion the ventilator will react by increasing the ventilation pressure at constant volume 5 5 Demand Flow NOTE A PEEP valve must not be fitted when using the ventilator in Demand Flow mode Demand Flow must be switched on for O2 inhalation To switch the AII6000A to Demand flow mode turn the ventilation settings regulator knob 6 until it engages in the fixed point marked by the white triangle The gre...

Page 24: ... Flow 1 Check the oxygen supply on the pressure reducer gauge Always change the cylinder in good time e g when the pressure is lower than 50 bar to ensure that oxygen is available for an adequate period 2 Close the valve of the oxygen cylinder 3 Switch off the AII6000A To prevent the ventilator being switched off unintentionally ON OFF switch 9 must be kept pressed down for at least 3 seconds unti...

Page 25: ...an acoustic signal sounds If audio response is enabled the user also hears additional information about the individual alarm Simultaneous disconnection and drop in oxygen pressure will initially set off only the 2 7 bar alarm Stenosis alarm Actual ventilation pressure exceeds the maximum ventilation pressure 20 or 45 mbar AII6000A briefly switches to expiration if the maximum ventilation pressure ...

Page 26: ...operating parameters are no longer within the permissible limits If audio response is enabled the ventilator announces Check pressure hose system and gas supply Alarm The battery is failing Failure of the automatic ventilation function must be expected Immediate steps must therefore be taken to provide alternative ventilation see 5 10 Alternative ventilation procedures If audio response is enabled...

Page 27: ...sh 5 Chinese 3 Press mask tube switch 1 as many times as necessary until the LED for the desired language lights up and a corresponding message is heard example LED 10 mbar language English message English Then press the alarm mute button 4 the new selection is stored Press the ON OFF switch 9 about 3 seconds to exit the language setting The LED for the selected lan guage goes out Select the setti...

Page 28: ... volume AII6000A has measured excessive airway resistance Check the airways or adjust respiratory frequency and minute volume settings to suit the patient Device malfunction Administer alternative ventilation The device is faulty or the battery is failing The device can no longer be used for ventilation You must therefore use another ventilation method Check pressure hose system and gas supply AII...

Page 29: ...Oxygen content of cylinder Oxygen volume volume of cylinder x cylinder pressure Cylinder volume x cylinder pressure oxygen content Example 1 10 L x 200 bar 2000 L Example 2 10 L x 100 bar 1000 L Real ventilation time Real ventilation time min oxygen content L MV L min Example O2 content 1000 L MV 11 L min This gives the following equation Real ventilation time 1000 L 11L min 91 min 1 h 31 min Real...

Page 30: ...0L MV 15L min This gives the following equation Real Demand Flow time 2000L 15L min 133 min 2h 13min 5 10 Alternative ventilation procedures If AII6000A ceases to function during a ventilation procedure the following alternatives can be applied Ventilation bags 1 Remove the patient valve from the tube or the mask 2 Replace it with the ventilation bag and perform manual ventilation Exhaustion of ox...

Page 31: ...t valve It is neither necessary nor permissible to remove the membrane in the emergency air intake for cleaning and disinfection 4 Crinkled misshapen and sticky valve membranes must be replaced 5 Perform the hygienic preparation as described in section 6 6 6 Reassemble the patient valve When reassembling make sure that the one way valves membrane is correctly positioned 7 Always perform a function...

Page 32: ...I6000A With a dry or damp cloth Wiping Not permissible Not permissible Patient valve In warm water with a mild household detergent Immerse in dilute solution so that all surfaces inside and out are thoroughly wetted without bubbles Wait until the full exposure time has elapsed After disinfection rinse all parts thoroughly inside and out with distilled water and leave to dry Rinsing programmed up t...

Page 33: ...on the pressure gauge hose must be rinsed with distilled water at least 8 times using the same principle 6 You can support the subsequent drying process with medical compressed air or medical oxygen Caution Then allow the components to dry thoroughly If any water is left in the patient valve or the pressure gauge hose of the ventilation hose the unit may not function correctly ...

Page 34: ...lanc or by specialists explicitly authorized by Ambulanc A complete functional check includes 7 2 Checking for leaks in the system 7 3 checking the patient valve 7 4 Checking the alarm systems We recommend that you always hold reserve stocks of the following items replacement washers for the connections one way valve membrane membranes for the patient valve 7 1 Intervals Before each use Perform a ...

Page 35: ...he site of the leak 3 Depressurize the system To do this first close the oxygen cylinder Switch on AII6000A briefly until the pressure gauge on the O2 cylinder reads 0 Then switch off AII6000A again 4 If leaks are discovered the defective components must be changed 5 After changing make a fresh check for leaks 6 If it proves impossible to eliminate the leak the ventilator will have to be repaired ...

Page 36: ...rom the patient valve 3 Switch on AII6000A 4 Switch the mask tube switch 1 to mask ventilation mode 5 Keep the ventilation connector on the patient valve closed with the flat of your hand during two successive inspiration phases The stenosis alarm should be set off If audio response is enabled the ventilator announces Check airways and minute volume Disconnection interruption of breathing system 1...

Page 37: ... announces Check pressure hose system and gas supply Power supply The alarm that indicates a failing battery is checked automatically in the self test that runs when AII6000A is switched on The power supply is in order if no alarm is set off when the valve on the oxygen cylinder is opened and AII6000A is switched on and starts to function ...

Page 38: ...entilation hose mask tube Remove kink or obstruction if necessary replace parts Tube incorrectly positioned Correct tube position AII6000A defective Arrange for repair Disconnection alarm Breathing system interrupted Ventilation hose leaking slipped out Check connections Mask tube incorrectly positioned Pressure gauge hose leaking slipped out AII6000A defective Arrange for repair 2 7 bar alarm oxy...

Page 39: ...no visual alarm flashing Alarm Device malfunctions Device defective No audio response Audio response deactivated Activate audio response Pressure gauge not reading 0 AII6000A defective Arrange for repair AII6000A will not switch off Operating error Keep button pressed for at least 3 seconds Unusually high oxygen consumption Leak in oxygen supply Find and eliminate leak MV too low Ventilation param...

Page 40: ...or by a specialist expressly authorized by the manufacturer Every 2 years Servicing the fittings in the oxygen supply system e g pressure reducer by the manufacturer or by a qualified specialist authorized by the manufacturer 9 2 Performing technical safety check and servicing We recommend that maintenance work such as inspections and repairs be performed only by the manufacturer Ambulanc or by qu...

Page 41: ...ncy proceed as follows Changing the battery 1 Make sure the ventilator is switched off 2 Open the battery compartment on the side of the AII6000A e g with a coin 3 Remove the empty battery 4 Insert the full charged battery Make sure it is inserted the right way round 5 Close the battery compartment again Warning The 3 7 V Li ion battery is a special battery for this unit Use only battery supplied ...

Page 42: ... 4 Push the emergency air intake interface back into the patient valve Outlet 1 Use pointed tweezers to pull the defective valve membrane out of the outlet 2 Insert a new valve membrane 9 5 Storage If you do not intend to use AII6000A for a long period we recommend the following storage precautions 1 Clean and disinfect the ventilator see 6 Hygienic preparation 2 Store AII6000A in a dry place 3 Th...

Page 43: ...II6000A User manual 1 601 00024 1 10 2 Optional Accessories Accessories Part No QTY PCS Pressure reducer 5 000 00169 1 Respirator air supply connection pipe 1 703 00003 1 Reusable mask Child 5 000 00174 1 Ventilator bag Ⅰ 2 601 00017 1 10 3 Consumables Spare parts Part No QTY PCS One way valve membrane 1 402 00030 1 Reusable ventilation hose 1 703 00021 1 Li Battery 1 115 00002 1 Caution Specific ...

Page 44: ...lse volume constant Gas input Medical oxygen Operating pressure 2 7 to 6 0 bar Minimum gas volume required 70 L min ATPD Insp exp Ratio 1 1 67 Ventilation frequency Continuously variable from 10 to 30 min 1 Minute volume MV Continuously variable from 3 to 16 L min ATPD MV tolerances 20 Max ventilation pressure 20 or 45 mbar O2 concentration 100 O2 Pressurized gas connection External thread 9 16 18...

Page 45: ...1 IEC60601 1 2 EN794 3 EN1789 Pressure gauge accuracy Deviation 1 4 99mbar Trigger sensitivity Deviation 1mbar Patient valve resistance Inspiration Expiration Emergency air intake 6 mbar at 30 60 L min 6 mbar at 30 60 L min 6 mbar at 15 30 L min Respiratory compliance 100 ml cmH2O 1 1 bar 100kPa 2 1 mbar 1 hPa 11 2Product structure diagram AII6000A Pressure reducer Flow control system Relief valve...

Page 46: ...H 1 601 00024 A3 0 39 46 11 3 Relationship between ventilation parameters The following diagram shows the relationship between the ventilation parameters minute volume and respiratory frequency ...

Page 47: ...aintenance Operational and normal wear and tear which includes for example the following components Filter Battery Articles for one time use etc Failure to use original spare parts Ambulanc is not liable for consequential harm caused by a defect if it is not based on intention or gross negligence Ambualnc is also not liable for minor physical injury to life or limb resulting from negligence Ambula...

Page 48: ...vere vibration and moisture Transport temperature is 40 50 relative humidity should be less than 95 Storage temperature 40 50 Moisture protection Up Stacking layers Handle with care Warning When the storage condition is beyond the required working environment the device should be placed in a standard environment at least 8 hours before enter into standby state 8 ...

Page 49: ...omer or the user of AⅡ6000A emergency ventilator should assure that it is used in such an environment 1 Emissions test Compliance Electromagnetic environment guidance 2 RF emissions CISPR 11 Group 1 The AⅡ6000A emergency ventilator uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment 3 RF e...

Page 50: ...hould be at least 30 Electrostatic transient burst IEC 61000 4 4 2 kV for power supply lines 1 kV for input output lines N A Mains power quality should be that of a typical commercial or hospital environment Surge IEC61000 4 5 1 kV differential mode 2 kV common mode N A Mains power quality should be that of a typical commercial or hospital environment Voltage dips short interruptions and voltage v...

Page 51: ... customer or the user of the AⅡ6000A emergency ventilator should assure that it is used in such an environment Immunity test IEC 60601 test level Compliance level Electromagnetic environment guidance Conducted RF IEC 61000 4 6 Radiated RF IEC 61000 4 3 3 Vrms 10 V m 80 MHz to 2 5 GHz N A 10 V m E1 Portable and mobile RF communications equipment should be used no closer to any part of the AⅡ6000A e...

Page 52: ...ons equipment could cause interference if it is inadvertently brought into patient areas For this reason an additional factor of 10 3 is used in calculating the recommended separation distance for transmitters in these frequency ranges b Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcas...

Page 53: ...W 150 kHz to 80 MHz outside ISM bands P V d 5 3 1 150 kHz to 80 MHz P V d 12 2 80 MHz to 800 MHz P E d 2 1 1 800 MHz to 2 5 GHz P E d 3 2 1 0 01 0 012 0 023 0 1 0 038 0 073 1 0 12 0 23 10 0 38 0 73 100 1 2 2 3 For transmitters rated at a maximum output power not listed above the recommended separation distance d in metres m can be estimated using the equation applicable to the frequency of the tra...

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