rrr Cetin “ACOMA INSTRUCTION MANUAL Acoma Lung Ventilator ART-21EX De ue Ruin Ge Ree eta Rerum Pee Rr coma hn mm eae cea NCC oe Cn a Pec CUS Rate sie our re Touma as ra meatier et ae eos eee ee RUN a aa oa eee Meme Rca [1m-v.1.04 |ART-21EX We thank you for selecting Acoma's Lung Ventilator ART-21EX. For both the patient's and your safety, as well as correct optimal performance and long life for the unit, carefully read this Instruction Manual before using this unit for the first time. Be forewarned that improper handling may not only result in unsatisfactory performance, cause a malfunction, or damage the unit, but could possibly even cause serious bodily harm.CONTENTS PRIOR TO USE 1,Safety Precautions 2.Accessories ----- 3. Nomenclature [1] Front view [2] Rear view- [3] Expiratory valve unit --- 4. Front Panel Composition & Functions [A] Respiratory mode selection area - [B] Ventilation condition preset area = Oxygen Consumption [C] Specific function preset area [D] Circuit pressure monitor area -- [E] Ventilation monitor area [F] Alarm area -- mw Error cords 5. Drive Circuit ---------+- 6. Pre-use Preparations/ Operational Checks [1] Preparations - - [2] Operational Checks - Si 7, Usage [1] Ventilation mode selection & Presetting of Heater-humidifier [2] Each ventilation mode 8. During-use Checks + 22 1-2~17 3-2~4 3-5~8 3-9~10 42~3 4-3~5 4-6~7 4-9~10 AI ~17 416~17 -5-2~4 6-2~13 6-14~29 7-2~5 ery aam =n Oza 9, Aftercare [1] Finishing daily use - [2] Aftercare - Parts/ components oe [3] Checking total hours of unit operation, and others - [4] A long period of absence from using unit MAINTENANCE, ABNORMALITIE: 10. Troubleshooting 11. Specifications - 12. Pre-use, During-use and ater: use Checkup items --10-2~7 =11-2~5 +12-2~9a Safety Precautions Warning Contraindication/Don’ ts Caution Preventing Hazardous Conditionssuoljnedeld nyse Safety Precautions [Intended use] Anesthetic ventilator designed aiming at assisting patient breathing during surgery er ccecrececcccccccccccccccccsceccesccescccees The following contents are important to ensure safe use of the Acoma Lung Ventilator ART-21EX, therefore be sure to take special care in reading them prior to using this unit for the first time, ° . . . . . [Extent of injury/damage denoted by:] Indicates that even while the unit is being used in a proper A Warnings manner, a deadly or extremely serious harmful condition could present itself should this problem occur. © Indicates that if the unit Is so misused, a great possibility will exist that critical bodily injury or even death could occur. ° . ° ° ° contraindication ® Mentions items exceeding the manufacturer's maximum YQ yea igucation liability such as the design limit of this medical equipment, improper use, as well as the manner of usage. ti @ Indicates that if so misused, a slight degree of bodily injury Au one (or damage only to the unit) may result. © Denotes important points, that although not linked with any Important harmful condition, could cause problems including unit malfunction, and thus would be helpful if made known to the user. : Meaning of the symbols ] Q © ‘Prohibition’ ; forewarning of things that should NEVER be done. @ ‘Requirements’, ‘Instructions’ items; indicating things that MUS be accomplished, ° Pecos ercccc ce cesveeeeceseescenessesenaesnses < Terminology> 1) Problem: An unfavorable equipment condition or unit malfunction 2) Harmful condition : Causing personal injury to the patient or unit operator< Qualification > Make sure this unit is used only by a ‘qualified’ Folow technician. < Instruction manual > (4 Make sure to carefully read all instruction manuals and other related documents prior to operating this unit as well as other related equipment (such as a heater-humidifier) for the first time so that you have a thorough understanding of operational | procedures). ) Read Make sure to carefully read the instruction manual of the ART-2 1EX Dedicated Blower (Compressor) “ART-218” prior to operating this unit for the first time so that you have a thorough understanding of its handling. | (Detailed operational/handling/ connection matters as well as Nw Precaution items are covered in this manual.) yy Read @ Coupled use of a “Pulse oximeter or Capnogram w/alarm” is strongly recommended, Full (For top patient safety, to back up the built-in alarm devices, observation especially should the ART-21EX stop operation or the respiratory circuit become detached, the unit should also be used in combination with bio-info monitoring units that provide patient-abnormality alarm warning.) Before using an external power supply (other than AC), be sure to check the waveform it produces. (Prior to using a DC/AC inverter, generator or UPS unit, ensure that it has a sinusoidal output.) Confirm suol]nedeiq a |2 = = < 3 S 8 S & & Ss a 0 Prepare Keep a manual drive ventilator ready for immediate use. (To be prepared for an emergency, such as the ART-21EX stop or ‘malfunction, a manually operated ventilator unit should be kept near at hand.) Always connect O2 For provision against power failure, make sure that \ 02 is connected to the ART-2 1EX main unit AT ALL TIMES, (Unless O2 is connected, should power fail, because the optional dedicated blower ‘ART-21B’ Is not backed up by the internal battery, it won’ t function at all. In such an event, O2 supply can act as a substitute for continuing blower drive. For this reason, O2 MUST be kept connected.) DS < Related to connection > oO Connect securely Contirm the power cord is fixed in place with the ‘Cord lock fitting’. (if the cord is not fixed with the fitting, should it be detached, all power to the unit and the dedicated blower will cease to be supplied.) < Related to usage > (o Confirm XX Start using the unit after checking activation of > ‘power failure’ alarm as well as the remaining capacity of the backup ‘internal battery’. (lf the unit is used with very low backup battery capacity, in emergencies such as power failure, unit operation on this battery will continue for only a short time. Also, such low capacity operation will shorten the battery life as well. Accordingly, periodically check on the remaining capacity, and if the backup battery is not fully charged, fully charge it. # While the ART-21EX is in use, this battery will be charging. TT@ Unless an AC power source is available, applicable functions are limited. Functional (Qnly the ventilator’ s control section can be driven by the backup restriction hattery, so the ‘Nebulizer’, ‘Heater-humidifier’ and dedicated blower ‘ART-21B’ won’ t function.) Fill ‘heater-humidifier’. (The ‘heater-humidifier’ should be filled with water up to noted level. Supply water’ Should it be operated without water, inspiratory gas temperature increases, and this could cause a serious danger such as the patient’ s airway being subject to a burn.) @ Be careful so that liquid such as water or medicinal liquid won't splash on the main unit. Prevent” (ART-21EX ventilator is not watertight or drip-proof, so a problem leakage could occur if the unit gets wet such as operation stopping.) (— @ Preset both ‘Low inspiratory pressure alarm level’ ae and ‘Excess pressure alarm level’ to a value near carefuly 0 the maximum inspiratory pressure. # If the ‘Low inspiratory pressure’ is preset to too low a level, should any leakage be caused from the respiratory circuit, an alarm won’ t activate. # Also, if the ‘Excess pressure’ is preset too high, there is concern XS that a pressure injury might be caused to the patient’ s lung. ( @ “Alarm level” should be set to a rather high sound ) level. (If preset too low, the alarm may not be audible above room noises.) # The level can be adjusted by manipulating the “Alarm level Set to higher level adjustment knob” on the rear panel.) suoljnedaig Ajejes Easuolneoaig Ajajes | — | 1-6 Prevent slogging Confirm that the ‘Expiratory flowmeter’ is free from clogging. (if the unit continues to be used with the meter clogged with water droplets, accurate measurement of ventilation volume will not be possible, and may lead to improper operation such as insufficient triggering.) < Measures against Abnormality/ Unit trouble > (~@ Immediately turn the unit OFF if it should function abnormally, then remove the power plug from the AC Remove plue outlet. (Should a malfunction or any abnormality such as high temperature, smoke, offensive smell, or a strange sound occur, immediately turn the power off and detach the power plug from the AC outlet. If the unit continues to be used as is, it may lead to a fire, electrical shock, or unit trouble.) (@ Ensure continual ventilation Jn case of an abnormality occurring, immediately Stop unit use, and ensure that patient ventilation continues by using a manually~functioning ventilator or a self-inflating Ambu bag. (Be sure to have a spare ventilator or backup Ambu bag at the ready near the main unit ART-21EX.) /) Uf the ‘Power failure’ alarm won’ t activate, immediately have the unit sent for ‘overhaul’ or oor ee ‘epair’ to an Acoma authorized service station. @ When the ‘Circuit breaker’ has activated, have the Prd repaired/inspected before resetting the breaker. (This breaker’ s activation alerts one that some abnormality has occurred within the main unit, Rather than reactivating the breaker, have the unit repaired/inspected by an Acoma authorized service station.)Celie ler tn AP ois < Usage environment/condition > a NEVER use this unit in a location that contains Don't use ‘inflammable gas. © NEVER place oils, other combustibles, or a flame near Cauflon- where “oxygen” is connected. flammable Q A bacteria filter should not be used on the ‘expiratory side’ of respiratory circuit (Should it be used, expiratory resistance will increase due to moisture accumulation from water and nebulizer medicinal liquid.) Don’t attach 8 Don’t connect any equipment/device to the ART-21EX, except those for which the unit has Coupled iti . . c broiited _ been specifically designed to have attached to it. — Don’ t connect any equipment/device to the Conned use ART-21EX, which might cause blockage of the prohibited respiratory circuit. Don't connect any equipment/device to the coueduse 4AT-21EX, which might be difficult to disconnect prohibited from the main unit. ONLY the (optional) specially designed ART-21B blower should be connected to its dedicated, conta Specially configured ART~21EX rear outlet. | | | suolnedaid ‘ojos lal8 Don't connect ONLY the specially designed heater-humidifier Should be connected to its dedicated, specially configured ART-21EX rear outlet. (Connection of other than this dedicated heater—humidifier may cause damage to parts/components or improper operation, which in an extreme case could even lead to ventilator stoppage.) Fit standard only. Don't attach anything on the ‘Side rail’ other than the standard optional items. (If any nonstandard item like a monitor is attached, it might fall down.) © Don’ t fit Both ‘Arm bracket’ & ‘rrigator stand’ SHOULDN'T be mounted on a single side rail, (Doing so would create an imbalance that might lead to both attachments falling down.) la 8 Careful about excess weight Don’t overload the ‘rigator stand’ with other than things required for fluid infusion/instillation (allowable weight, 2kgs.). (if other than the requisites for medicinal liquid infusion instillation are hung from the stand, they might fall down or even cause damage to the unit.) S/ S Careful about excess weight Don’t place anything exceeding an allowable weight of ‘10kgs’ on the ‘Monitor stand’. (Such might lead to an accident should a unit/device fall down.) < Related to electromagnetic noise > © Don't use Avoid combined use with an MRI (magnetic resonance imager).8 Don’ t use A mobile phone, transceiver or radio controller should NEVER be used in the same room while the ART~21EX is in use. (Electromagnetic waves from such sources could cause a unit malfunction which might even threaten the patient's life.) 8 Don’t use < Related to how-to-use > NEVER use a defective ART-21EX (plus, ART-21B blower) suoljnedeld an — | Don’ t use Don't use the ART-21EX while the “improper presetting alarm” has activated. (Correct tidal volume and respiratory rate will not be available.) 8 Don’ t block The Expiratory valve unit’s ‘Exhaust port’ should not be blocked. (Should it be blocked, the patient’ s expiratory gas cannot be expelled out of the port, and could lead to an accident or unit malfunction.) Don’ t use NEVER use the ART-21EX operating on backup battery power while transporting a patient. (The internal battery is solely designed to serve as an emergency back up power source, such as AC power be interrupted due to power failure, in order to continue ventilator operation for a limited duration until the main AC source is recovered. Accordingly, the ART-21EX unit SHOULD NOT be moved from ward to ward if it is operated on the backup battery.) Don’t contact Be careful that the ‘Expiratory valve unit’ doesn’t contact the patient’ s/operator’ s skin. (This unit normally reaches a temperature of approx, 40°C, so if it contacts skin, it might lead to a minor burn.)suoljneosid Ayajeg Ee 1-10 oF ia @ All “Disposable products” should NEVER be reused. | (As materials and design are intended for one-time use, reuse could cause holes, cracking or loose joints that would result in leakage.) # These products should be disposed of in a safe, appropriate | manner in order to avoid contamination and infection, oy Don’ t reuse ___< Unit maintenance > '@ ‘Don’t disassemble or modify the unit. @ fl (Doing so could lead to a fire, electrical shock, or unit trouble.) disassemble } 8 Don’ t damage Power Cord. (Cord shouldn’t be stepped on or forcibly pulled, because if damaged Don't i damage and continually used, fire or electrical shock may occur.) % Usage environment/ condition > @ Be sure to have the drive gas (02 or AIR) maintained within the rated supply range of ‘350~500kPa’. Proper range < Related to connection/attachment >_ (4 @ BOTH ‘02/AlR’ pressure tubes should be connected. " supply (Be sure the ‘AIR’ and ‘Oz’ tubes are both connected, because when the power is turned on, if only the ‘O2’ tube is connected, the main unit won’ t operate.) ) / @ Connect ‘Heater-humidifier’ to its dedicated outlet (As ‘Heater-humidifier’ operation is linked with the ART-21EX, when | the ventilator’ s “Power switch’ is OFF, power will not be supplied to | the humidifier.) oY FollowBe sure to connect the power plug to a properly grounded medical-purpose 3-prong outlet. Follow & Be sure to grasp the power plug, not cord, when detaching it from the outlet. Grasp plug (if the Cord is pulled out improperly, damage to it may later cause an electrical shock or a fire.) ® Connect securely Connections should be tight # Make sure the ‘Respiratory circuit’ has been securely attached. If the connection is loose, gas leakage may occur. # Attach the ‘Expiratory valve unit’ securely. If the connection is loose, not only gas leakage may occur, but also the ventilation volume and PEEP pressure might be incorrect. # When screwing on the ‘Nebulizer cup’, make sure it is level. Leakage test Prior to connecting the ‘Respiratory circuit’ to the ) patient, make sure to run a leakage test. (As long as no pressure decrease is detected within the plateau period, the circuit is free of gas leakage.) # Should drops of condensation appear during usage, gas is leaking out from that portion, 0 Prevent infection Attach Bacteria filter’. (When inspecting the respiratory circuit, attach a ‘Bacteria filter’ in between the ‘Test lung’ and ‘Y-adaptor’ in order to help prevent cross~ infection.) # For more details on filter use, read the dedicated attached document. ‘anew one Replace with (Should the filter clog, filtration ability will be greatly lost, so for top ‘inspiratory bacteria filter’ should be replaced every 24 hours. filtration performance and to prevent infection, replace it with a new one every 24 hours.) # For the use/replacement of this filter, refer to its attached relevant document. suolnedaid Ajajeg 1-11suojjneoaig Ayajeg e 1-12 Replace periodically Replace the ‘Respiratory circuit’ ‘once a week’. (Over an extended period, bacteria will propagate within the Respiratory circuit, so to prevent cross infection, replace it with a new one at least once a week, or preferably more often.) (o Inspect XS ® Proper suction < Checking of proper unit operations > Prior to ventilator use, make sure to perform operational checks according to the “Pre-use, During-use and After-use Checkup Items” found at the end of this manual. (Following each inspection table, “Preparatory check” +“Pre-use operational check”, “During-use check”, and “After-use check”, ensure that your ART-21EX operates normally and no problem is detected, so as to be ready for the next use.) < How-to-use-related caution > When using an enclosed-type intratracheal suction catheter, the suction unit should be used with proper pressure so that an excessive negative pressure is not produced within the respiratory circuit. (Excessive negative pressure might cause damage to the pressure transducer within the equipment.) ® Drainage Empty ‘drains’. (Make sure water accumulated within the ‘Inspiratory drainage cup’, ‘Expiratory corrugated tubes’ and ‘Expiratory valve unit’ are all emptied out on a timely basis, as otherwise, expiratory resistance and PEEP might occur, and the collected water might back up into the patient.) # Care should also be taken that the corrugated tubes are set at the right position and height.@ Periodically empty the water that might have : accumulated within the expiratory valve unit. Drain a! rexuler” (Even if water collected in the unt is drained automatically, a manual discharge should also be made at regular intervals.) @ Protection cover’ should be closed other than when changing preset values. (This cover serves to protect the parameters entered inthe ‘Preset dial’ section being accidentally changed.) Close suolnedaig on — | < Moving the ART-21EX main unit and stability of peripheral equipment/devices > When moving the main unit, be careful to: 1. Remove aif the units/devices placed on the mgt (optional) monitor stand 2. Unlock the castors 3. Hold the handle on the main unit’ s front 4. Keep the unit from tioping 5. Move the unit in a single direction (to the front or to the rear). (If the unit is moved with the castors locked, or forcibly, injury due to the unit falling down may cause damage to the product.) # Horizontal (left or/right) movement of the unit might cause it to fall down. Q ‘Supporting arm’ position should be changed only ‘Am after loosening the levers. position (Should the levers be locked, and an attempt made to forcibly move the unit, it might cause the unit to fall down or damage to the arm.) 1-132 =F 2 < 2 2 3 S = = Ss @ < Replenishment/Replacement > @ if the battery-operability becomes extremely short, or after every ‘two years’ use, replace the battery Replace | with a new one. ith “i one (This is probably due to the battery running down due to age/use. Replace it with a new one.) # Battery life is approx. ‘two years’ . Ask an Acoma authorized service station for a replacement. BE SURE to use only Acoma-approved replacement “cemine’ Parts. parts (Use of substitutes may cause unit malfunctioning.) Sterilize or disinfect the ‘Expiratory valve unit’ every time after using it Sterilize/ (To prevent infection, this unit should be sterilized in an autoclave or disinfect disinfected with alcohol after each use.) X Sterilization: Autoclave (121°C, 15 minutes) X Disinfection: Alcohol # When using disinfectant alcohol: Attach the Expiratory valve unit (securing it with the fixing screws) to the main unit, and let it /a/e for more than 30 minutes, This is because the alcohol remaining within the expiratory \ flowmeter in the unit needs to be dried out in advance.) oe Diaphragm’ should be removed before sterilization/ disinfection. (When sterilizing/disinfecting the “Expiratory valve unit’, the “Diaphragm holder’ and ‘Diaphragm’ should both be removed in advance so that the internal portion of the valve unit can be thoroughly sterilized/ disinfected.) RemoveAttach carefully \ Diaphragm’ and ‘Diaphragm holder’ should be attached securely. (Make sure the ‘Diaphragm’ is positioned correctly when attaching it to the “Expiratory valve unit’ . Make sure the diaphragm falling-off prevention screw fully secures the ‘Diaphragm holder’ . If the diaphragm’ s positioning is wrong, or its attachment imperfect, patient circuit leakage may result, leading to abnormal functioning.) Should a problem occur, attach a note to the ventilator indicating such, and have the unit properly Note problem fepaired by an Acoma authorized service station as soon as possible. Disposables’, ‘Residues’, and ‘Units/ Dpereht accessories coming to the end of their life’ # They should be disposed of as medical waste in an appropriate manner. @ Ensure uni stability /f required to transport the ventilator unit to an >\ Acoma authorized service station (e.g., for repair), be sure to consign it to an expert ‘carrying company’. (The unit should be transported under the stable state by means of applying cushioning materials and fixing aids to avoid excessive vibration or impact and the unit falling~down.) # Unless such is complete, it might cause trouble/damage to the unit. suojynesaig an — | 1-15Follow Ensure unit storage environment. (The unit should be placed in a location free from such unfavorable environmental conditions as improper atmospheric pressure, temperature and humidity (Refer to each tolerance mentioned in the specifications on p.11-5), as well as free from improper ventilation, direct sunlight, dust, salinity and sulfur-laden air. Meanwhile, the equipment shouldn’ t be placed in a room where chemicals are stored or combustible gas is used while guarding against unstable placement or handling such as inclining the unit, excessive vibration or impact.) 8 Periodic. maintenance Be sure to have the unit either ‘inspected or overhauled’ as advised below. (To maintain normal functioning, have the unit inspected ‘once a year’ [or every ‘5,000 hours’ ] by an Acoma authorized technician.) # After ‘two years’ of use (or every ’ 10,000 hours’), the unit should be overhauled by an Acoma authorized service station.[The following precautional notes (YAKUHATSU No.495, dated June 1,1972) are provided by the Ministry of Health, Labor and Welfare to be included with medical sers to help ensure proper unit usage, as well as ¢ 1. Only properly trained should operate this equipment * 2. When setting up equipment, attention should be paid to the following items: . a. Do not place equipment where it may be splashed with water. 2 b. Place unit in a location free from unfavorable environmental conditions such as those whiche may be a result of improper atmospheric pressure, temperature, humidity, ventilation, direct® sunlight, dust, salinity and sulfur-laden air. 5 c. Guard against unstable placement or handling such as inclining the unit, excessive vibratior cr impact (including during transport). 4. Do not place equipment in a room where chemicals are stored or combustible gas is used. @. Carefully check power source frequency and voltage, as well as permissible current (or power consumption). {. Unit should be properly grounded. 3. Check the following items before using equipment: a. Inspect switch contact condition, polarity, dial settings, and meter indicators, as well as confirming that equipment operates properly. b. Confirm that equipment is fully grounded. ©. Confirm that all cord connections are correct and complete. : d. Special attention should be paid to combined use of other equipment which may electrically’ interfere with the unit and thus lead to incorrect operation, misdiagnosis or cause danger, e. Any external circuit directly connected to the patient should be double checked for safety. 4. Check the following items while using equipment: ‘a. Frequency/length of use of unit for diagnosis/treatment should not be excessive. b. Maintain constant surveillance of equipment and patient to make sure that if an abnormality occurs, it wil not go undetected. . As patient safety in the primary consideration, immediately stop using the unit if a malfunction occurs or the patient shows some abnormality. 4. Be sure to correctly position equipment to insure that it does not contact the patient. ‘* 5. Check the following items after using equipment: 2a. After returning operational switches, dials, etc., to their pre-use condition as the maker prescribes, turn the power OFF. . Do not pull cords out with excess force when disconnecting them. c. Equipment should be stored under conditions noted previously in 2a - 2d. d. Clean all accessories, cords, terminals, etc., then put them together all in one place. @. To facilitate quick next use, equipment should always be fully cleaned immediately after . use. : . If a malfunction has occurred, properly identify the trouble and have the unit serviced repaired by the appropriate authority. : 7. Do not recondition the equipment. 3. Maintenance and checking a. Equipment and parts require periodic checkups. b. Before using equipment which has not been operated for a long time, make sure itis. functioning properly and safely. 9, Others Read the special precautional notes in the instruction manual carefully before using the ‘equipment for the first time. soe seeee seeeeee 1-17MEMO| 2 | Accessoriessajjosseooy Ea 2-2 Accessories @ Pressure tube (AIR, O2! 5m) @ Respiratory circuit set (disposable) #'The assembly drawing for this set is included in the accessory package. @ Supporting arm F + + @ Testlung © Drainage cup « © Diaphragm- + tt @ Bacteria filters +--+ ++ ® Heater-humidifier (MR&10) - © Humidification chamber(MR210 for adult) - @ Instruction manuali Nomenclature [1] Front view [2] Rear view [3] Expiratory valve unitaumejouowion 3-2 13 Nomenclature [1] Front view (Fig.2) Front panel Each respiratory mode and alarms can be preset on this panel. # For details, refer to 4, Front panel composition & functions. ‘Protection cover’ should be closed other than when changing preset values. (This cover serves to protect the ‘Preset dial’ section from unexpected preset changes due to inadvertent touch.) . Nebulizer port Connect the ‘Nebulizer tube’ (included in the ‘respiratory circuit’ set) to this port..» Inspiratory port The gas from the ventilator main unit is sent to the patient through this port. Attach the ‘Bacteria filter’ to the ‘inspiratory port’ side. ‘Inspiratory bacteria filter’ should be replaced every 24 hours. ({f the filter is clogged, filtration ability is largely reduced. @ To prevent infection, replace it with a new one every 24 ; hours.) Beplecs with # For the use/replacement of this filter, refer to the came attached relevant document. 2 s 3 = g ce a = 3 .. Expiratory valve unit ‘Expiratory valve’, ‘Expiratory flowmeter’ and ‘Auto drain’ are built within this unit. While the ventilator is operating, this unit is kept warm (approx. 40°C). # For detailed functions, refer to [3] Expiratory vaive unit. 5 The Expiratory valve unit’s ‘Exhaust port’ Contraindication/] should not be blocked. (Should it be blocked, the patient's expiratory gas couldn't Don’t block be let out of the port. It might cause an accident or unit's improper operation.) Contraindication/| Be careful not to make the ‘Expiratory valve unit’ contact the patient's skin. (This unit is normally warmed up to approx. 40°C. if the Don't contact skin touches the unit for hours, it might lead to a low-temperature burn.) Exhaust water within the expiratory valve A\caution unit periodically. (The water collected in the unit should be manually discharged at regular intervals, in addition to that by the ‘Auto drain’.) Drain at regular intervals 33eume|oucuoN Ia 3-4 Sterilize or disinfect the ‘Expiratory valve unit’ every time after using it. (To prevent infection, this unit should be sterilized or @ disinfected on every use by means of either ‘autoclave ae sterilization’ or ‘alcohol disinfection’. Sterilize/disinfect # When using disinfectant alcohol: Fit the unit (fix it securely with fixing screws) to the main unit, and make it operate for more than 30 minutes. This is because the alcohol remaining within the expiratory flowmeter in the unit should be dried out in advance.) Drainage cup Exhausted water is collected here. Heater-humidifier attachment bracket Fit a ‘Heater-humidifier to this bracket. Before using this humidifier for the first time, carefully read the attached document (dedicated to this unit) as well as its instruction manual. (Detailed operation/connection manners and precaution items are mentioned in these materials. Prior to use, refer to them, making sure you have a thorough understanding of operational procedures.)[2] Rear view aun}ejoUsWON cE (Fig.3] 7 ...« Supporting arm fixing fitting _‘Supporting arm F is fitted here. elnsert the arm securely as 5 far as it goes. (Otherwise it might slip/fall off.) Fix the arm securely. (Tightening of ‘Arm fixing screw’ should be sure. Unless tightened sufficiently, the arm might come off or its positioning might become unstable, thus leading to detachment of corrugated tube.) 8 ..... Sound level adjustment dial Alarm sound level can be adjusted by turning this dial (To increase, turn it clockwise, while if ted counterclockwise, the level decreases). In case of warning the battery remaining capacity reaching ‘o’, however, an alarm sounds with the maximum level regardless of the dial’s position. 35aunjejouswon ca 36 To ensure patient safety, set the ‘Alarm A Warning | sound level’ to a sufficiently audible level. (If preset to a lower level, there might be such a case that the alarm becomes inaudible due to environmental noise.) Preset to a larger level .». Hour meter This meter's reading is cumulatively up to ‘999999.9", While the main unit is operating, the decimal point blinks, which means that the cumulative hours of usage is being counted Be sure to have the unit either ‘inspected or Z\ caution overhauled’. @ (To maintain normal functioning, have the unit inspected ‘once a year'(or, every ‘5,000 hours’ use) by an Acoma . authorized technician.) Periodic maintenance —_# After two years(or 10,000 hours) of use, the unit should be overhauled by an Acoma authorized service station 10 ..... Cireuit breaker (5A) This breaker activates when a current over ‘5A’ is supplied to shut off power input to the main unit. Power consumption for this ventilator is ‘260VA’ (including that for the dedicated optional blower ‘ART-21B)). Once this safety device has activated, take an immediate measure to have your ART-21EX repaired/inspected by an Acoma authorized technician. When the ‘Circuit breaker’ has activated, don't ‘reset’ it, but have the unit repair/ inspected, (This breaker's activation means that something Follow abnormal might have happened within the main unt. In place of recovering it, ask for unit repair/inspection by an ‘Acoma authorized service station.) Main unit power connection port Power input port for the main unit. When the unit is to be shipped from the factory, the ‘Power cord’ is connected and fixed with the ‘Cord lock fitting’. # A power source of '100~240V, over 5A’ should be connected to this port. Confirm that the power cord is fixed with /\ Warning the ‘Cord lock fitting’. (Unless fixed with this fitting, should the power cord have come off, power is not supplied to both of the main unit and dedicated blower.)Connect the power plug to a ‘Medical use A\cau nN} AC SP outlet’. (To prevent an electrical shock, the main unit should be connected to a medical use 3P outlet.) An appropriate source ART-21B dedicated outlet Through this AC outlet, power is supplied to the dedicated blower ‘ART-21B’. Insert the power plug (originating from ‘ART-21B)) into this outlet and fix it with the cord lock fitting. Confirm that the power cord is fixed with the ‘Cord lock fitting’. z Ss 3 B s EE = = o 37 (Unless fixed with this fitting, should the power cord have come off, power is not supplied to the dedicated blower.) Fix securely Before using this blower ‘ART-21B’ for the first time, carefully read its instruction manual. (Detailed operation/connection manners and precaution items are mentioned in this manual. Prior to use, refer to it, making sure you have a thorough understanding of operational procedures.) n/| Any unit other than this optional blower should not be connected to the ART-21B dedicated outlet. Don’t connectedaumelouewion 3-8 Heater-humidifier dedicated outlet Through this outlet, power is supplied to this humidifier. Insert the humidifier's power plug into this outlet. Contraindication”| Any unit other than a designated Don'ts heater-humidifier should not be connected to this outlet, 14 Don't connected (Connection of other unit may cause damage to parts/ ‘components or improper operation, thus leading to ventilator stoppage in an extreme case.) Connect ‘Heater-humidifier’ to its dedicated outlet. (The ‘Heater-humidifier’ operation is linked with the ART-21EX ventilator, so if the latter’s ‘power switch’ is Follow not set to ON, power is not supplied to the humidifier.) ao 2 gas inlet ‘Oz’ intake port, of which connection section is of DISS standard. Using a spanner on hand, connect the pressure tube (green) securely. By way of precaution against power failure, /\wam ING | connect ‘Oz’ always. 16 ous (Since the optional dedicated blower ‘ART-21B" is not backed up in the event of power failure, the blower To be connected should be driven with ‘O2’) at all times AIR gas inlet “AIR’ intake port, of which connection section is of DISS standard. Using a spanner on hand, connect the pressure tube (yellow) securely. .. ART-21B dedicated connection port The ‘AIR’ supplied by the optional dedicated blower ‘ART-21B’, is linked to this port. ‘Connection coupler’ should be connected securely.[3]Expiratory valve unit ‘Expiratory valve’, ‘Expiratory flowmeter’ and ‘Auto drain’ are incorporated within the expiratory valve unit. @Expiratory flowmeter | ‘@Fixing screw (Exhaust port @Expiratory port Fixing screw | Water level audit window | (for auto drain) ‘@Drain exhaust port ~_| | @Manual exhaust cock @Dreinege cup (for auto drain) (Fig.43 © Expiratory flowmeter Serves to measure the patient's expiratory volume. To prevent waterdrop sticking to the meter, the whole unit is heated up to approx. 40°C by means of a heater. Confirm that the ‘expiratory flowmeter’ is L \ Warning | free from clogging. @ (If the unit continues to be used with the meter clogged with waterdrops, accurate measurement of ventilation Prevent clogging volume becomes not available, in addition, it may cause improper operation such as insufficient triggering.) traindication/| Be careful not to make the ‘Expiratory ts valve unit’ contact the patient's skin. Don’t contact (This unit is normally warmed up to approx. 40°C. if the skin touches the unit for hours, it might lead to a low-temperature burn.) Auto drain mechanism: Water accumulated within the unit is automatically exhausted. After the main unit's power ON, a built-in timer serves to contro! so that water is discharged at fixed intervals, namely, in ‘30 seconds’, ‘90 seconds’, and after this, every ‘30 minutes’. aunjejouswWoN, ei 3-9auyejoueton ea ® Exhaust port The expiratory gas breathed out by the patient, is exhausted from this port. Contraindication/) The Expiratory valve unit's ‘Exhaust port’ Don'ts should not be blocked. Don’t block (Should it be blocked, the patient's expiratory gas couldn't be let out of the port. It might cause an accident or unit's improper operation.) @® Fixing screws The ‘Expiratory valve unit is connected/fixed to the main unit with two screws. Unit connection should be sure. (Fit the ‘Expiratory valve unit’ securely. If its fitting is insufficient, gas leakage is incurred. Besides, correct: ventilation volume and PEEP pressure might not get Connect securely obtainable.) @ Expiratory port Connects to the corrugated tube on the expiratory side within the patient circuit. ; Circuit connection should be sure. AX Caution : ; (Connect the ‘Respiratory circuit’ securely. If its connection @ is insufficient, gas leakage is incurred.) Connect securely © Water level audit window (for auto drain) Through this window, the level of the water collected within the expiratory valve unit can be confirmed. © Manual exhaust cock (for auto drain) Pulling this cock towards you, allows to manually discharge water within the expiratory valve unit. . Exhaust water within the expiratory valvel AV Caution | unit periodically. (The water collected in the unit should be manually] discharged at regular intervals, in addition to that by ‘Auto drain’) Drain at regular intervals @ Drain exhaust port Water accumulated within the unit is exhausted through this port. ® Drainage cup A polyethylene receptacle (capacity: 250mL) to accept discharged water.| 4 | Front Panel Composition & Functions zi [A] Respiratory mode selection area [B] Ventilation condition preset area mw Oxygen Consumption [C] Specific function preset area [D] Circuit pressure monitor area [E] Ventilation monitor area [F] Alarm area m@ Error codessuO}}OUNJ Y UOI}IsodWOD jaueg jUoI4 ES ‘As given in Fig.5, the front panel is divided into six regions according to each function, aiming at operational simplification. A. Respiratory mode selection area B, Ventilation condition preset area C. Specific function preset area D. Circuit pressure monitor area E. Ventilation monitor area F. Alarm area EMR Coie oleae rola 8 @ Respiratory mode selection key Acoma ventilator ART-21EX incorporates the following four respiratory modes. a) vev Volume Control Ventilation b) PCV Pressure Control Ventilation c) SIMV Pressure Support Synchronized Intermittent Mandatory Ventilation + Pressure Support Ventilation a) CPAP Continuous Positive Airway Pressure@ENT button When changing the currently selected respiratory mode and/or each preset value, pushing this button serves to confirm/register each entry. If a new respiratory mode is selected, the portions requiring to preset (in Fig.7 — [B] Ventilation condition preset area) blink. Turn the dial(s) at the required portion(s) to preset to desired value(s). Then push the ENT button’ to enter the preset value(s). From the point of time when the ‘ENT button’ has been pushed, the unit starts operation in the newly selected respiratory mode. # Unless the ‘ENT button’ is pushed (viz., new entry is registered) within seconds’ after changing to desired mode/ preset value(s), this new entry is cancelled, so no change is made in the mode/ preset value(s) currently in operation. [B] Ventilation condition preset area Select each respiratory mode, and only the portion(s) requiring presetting, are lit. inwitny time ee Teal volume Respiratory rate ow (gage) (68). a8 spre pressue 6G) (een CFig.73 @Tidal volume indicator Reads the tidal volume preset by the ‘Tidal volume preset dial’. @Tidal volume preset dial Serves to preset tidal volume. By turning this dial clockwise, the preset value increases, and counterclockwise, it decreases. Tidal volume is presettable within the range of ‘650~2,000mL’. @Respiratory rate indicator Reads the respiratory rate preset by the ‘Respiratory rate preset dial’. SUOIJOUNY * UO!ISOdWOg jaueY JUO14 EIsuoljouny 9 u IH[sodwog jeued UOL4 Ei @Respiratory rate preset dial Serves to preset respiratory rate. By turning this dial clockwise, the preset value increases, and counterclockwise, it decreases. Each respiratory rate can be preset in ‘one time/min.’ increments as follows: a) In the VCV mode: 6~60 times/min. b) In the PCV mode: 6~60 times/min. ©) In the SIMV pressure support mode: 0~60 times/min. @Inspiratory time/ I:E indicator Reads the inspiratory time (or, Is) preset by the ‘Inspiratory time/ I:E preset dial. ®Inspiratory time/ |:E preset dial Serves to preset inspiratory time (or, |:E). By turning this dial clockwise, the preset value increases, and counterclockwise, it decreases. ‘Inspiratory time’ can be preset in the range of '0.3~5 secs.’, and ‘LE’, in ‘1:1 ~ 1:3’. When required to preset ‘I:E' to less than ‘1:1’, tum the preset dial with the 'ENT button’ continually pushed in, and the presetting becomes available up to three steps below 1:1 (viz., 1:0.3, 0.5 and 0.7). In this case, however, the ventilation method becomes IRV (inversed Ratio Ventilation). (Inversion of IE ratio) @ Inspiratory pressure/ Pressure support pressure indicator Reads the Inspiratory pressure/ Pressure support pressure preset by the “Inspiratory pressure] Pressure support pressure preset dial’. @Inspiratory pressure/ Pressure support pressure preset Serves to preset inspiratory pressure/ pressure support pressure. By turning this dial clockwise, the preset value increases, and counterclockwise, it decreases.Inspiratory pressure/ pressure support pressure can be preset in the range of ‘1~40hPa’, in ‘thPa’ increments. # The preset inspiratory pressure/ pressure support pressure, become “+PEEP™ (viz., PEEP applied). The actually operating pressure is PEEP pressure, plus, inspiratory pressure ‘pressure support pressure. [Example] If the PEEP pressure is preset to ‘ShPa’, and the inspiratory pressure/ pressure support pressure, to '15hPa’, the result (actually operating pressure) becomes ‘2OhPa’. (PEEP indicator Reads the PEEP preset by the ‘PEEP preset dial. (PEEP preset dial Serves to preset PEEP. By tuming this dial clockwise, the preset value increases, and counterclockwise, it decreases. PEEP (Positive End-Expiratory Pressure) can be preset in the range of '0~20hPa’, in ‘thPa’ increments. @Preset O2conc. indicator Reads the Oz conc. preset by the ‘Preset Ozconc. preset dial’. @Preset O2 conc. preset dial Serves to preset Oz conc.. By turning this dial clockwise, the preset value increases, and counterclockwise, it decreases. The oxygen concentration can be preset in the range of '21~100%’, in ‘5%’ increments (viz., 21, 25, 30 ...95, 100%).Oxygen consumption Oz consumption is an aggregate of a) Oz volume in mandatory ventilation and b) Oz volume in-circuit constant flow. a) Oz volume in mandatory ventilation (L/min.) Minute ventilation volume x (FiO2-0.2)/0.8 Minute ventilation volume = Tidal volume(L) x Respiratory rate (times/min.) b) Oz volume in-circuit constant flow (L/min.) {Circuit constant flow x Expiratory time x Respiratory rate / 60} x {(FiO2-0.2)/0.8} Expiratory time (sec.) = (60/Respiratory rate) x {1-1/ (1+L:E ratio)} (in case of I:E ratio = '1:2, substitute ‘2’ for the ratio) That is, the sum total of a) and b) becomes Oz consumption. Precise Oz consumption differs depending on each selected mode, thus making calculation complicated largely. As a general procedure, however, utilizing the following simplified expression will help you obtain this consumption. O2consumption (L/min. = (Minute ventilation volume + Circuit constant flow/2) x Fi O2 [Calculation example] 1) In the VCV mode — When preset to Tidal volume 500mL, respiratory rate 12 times/min, I: ratio 1:2, preset Oz conc. 60%, assistor ventilation set to ON, and trigger sensitivity 5L/mi a) Ozconsumption in mandatory ventilation 0.5 x 12x (0.6-0.2) /0.8 = 3 (imin.) in-citcuit constant flow (when assistor ventilation is set to ON: ity + 5LJmin,; if set to OFF: 2L/min.) Expiratory time (sec.) = (60/12) x {1-1/ (1+2)} = 3.3 secs. (10 x 3.3 x 12/60) x {(0.6-0.2) /0.8] = 3.3 (L/min.) Oz consumption (L/min.) = a) + b) =3 + 8.3 = 6.3 (Limin) If this is calculated utilizing the above cited simplified version — (6 + 10/2) x 0.6 = 6.6 (Umin.) 2) In each of the PCV, SIMV Pressure Support and CPAP modes — When preset to O2conc. 40%, Minute ventilation volume 6L: a) Oz volume in-circuit constant flow (L/min.) Circuit constant flow x {(FiQz-0.2)/0.8} = 10 x {(0.4-0.2) /0.8} = 2.8 (L/min) b) Minute ventilation volume's Oz volume (L/min.) Minute ventilation volume x {(FiQ2-0.2)/0.8} = 6 x {(0.4-0.2) /0.8} = 1.5 (Ymin.) # As regards the minute ventilation volume, use the numerical value given in the ‘Minute ventilation volume alarm preset bar graph’. Additionally, this minute ventilation volume can be also estimated by the expression [The patient's body weight x 10mL x respiratory rate} Ozconsumption (L/min.) = a) +b) = 2.5 + 1.5 =4 (Limin.) If this is calculated utilizing the above cited simplified version — (6 + 10/2) x 0.4 = 4.4 (Limin,) suoljoun4 *9 UOl}Isodwiog jaued jUuoY | = | 45SUO!]OUNY *P UO!}Isodwog jaueg JUoIy ES 46 [C] Specific function preset area @Plateau indicator Reads the plateau value preset by the ‘Plateau preset button’. Plateau preset button Preset plateau (9Ti: plateau time's ratio to inspiratory time) with ‘+/~’ buttons. Plateau: EIP (End-Inspiratory Pause) can be preset in the range of ‘0~30%’ to inspiratory time, in ‘5%T? increments. [Example] a) VCV mode: If preset to respiratory rate 10 times/min. and I:E ratio 1:2, the inspiratory time becomes (60/10) x 1/3 = 2 seconds. Assuming that the preset plateau is '10%T/, the plateau time results in being 10% of this inspiratory time of 2-second, namely, ‘0.2 sec. b) SIMV pressure support mode: If preset to inspiratory time 1.5 sec. and plateau “10%T?, the plateau time becomes 10% of 1.5 sec., namely, '150ms'. @Assistor ventilation ‘ON/OFF’ button Pushing this button allows to make assistor ventilation function ready to start, and the indicator lights. Under this state, the circuit constant flow becomes the preset trigger sensitivity + SL{min. Push this button again, and assistor ventilation is interrupted, and the indicator goes out. Then the circuit constant flow returns to “aL min’. # ON/OFF is available only in the VCV and PCV mode. This button pushing in other modes is no good for initiating assistor ventilation function. ®Trigger sensitivity indicator Reads the trigger sensitivity preset by the ‘Trigger sensitivity preset button’. @Trigger sensitivity preset button Preset trigger sensitivity using the ‘+/-’ buttons. This sensitivity can be preset in the range of '3~15L/min.’, in ‘1L/min.’ increments. When assistor ventilation is set to ‘OFF, the ‘Trigger sensitivity indicator reads nothing. @Trigger indicator This indicator lights when assistor ventilation has been triggered by the patient's spontaneous breathing.ay ART-21EX incorporates a detection function against detachment of respiratory circuit. Accordingly, if the circuit is intentionally detached, for instance, while sucking phlegm, assistor ventilation function won't activate. In such an event, reconnect the circuit, which serves to || restart measurement of circuit constant flow (or the patient's expiration) with the expiratory flowmeter. The assistor ventilation function is thus recovered. @SIGH ‘ON/OFF’ button a) In the VCV mode: Pushing this button allows to make SIGH function ready to start, and the indicator lights. The ventilation volume 1.5 times larger than that preset by the ‘Tidal volume preset dial’ @, is sent to the patient every ‘100 breaths’. b) In the PCV mode: SIGH activates with the inspiratory pressure 1.5 times larger than that preset by the ‘Inspiratory pressure preset dial’ (0. @Nebulizer ‘ON/OFF’ button In every mode, if this button is pushed, the nebulizer is set to ‘ON’, and the indicator lights. Then it operates synchronized with the ‘inspiratory phase’. Push the button again, and the nebulizer stops functioning, and the indicator goes out. For safety's sake, an auto-stop function (in ‘30 minutes’) is furnished. # Since only a part of inspiratory gas is used for nebulization, the nebulizer use doesn't exert any influence on tidal volume. @Manual ventilation button In the ‘expiratory phase’, while ‘ON’ button is being continuously pushed in, an inspiratory action continues.The maximum ventilation volume in each mode is as follows: 'VCV ..... Two times larger than the preset tidal volume, or for 5 seconds PCV) ..... Two times longer than inspiratory time, or for 5 seconds 'SIMV Pressure Support} ..... Two times larger than mandatory tidal volume, or for 5 seconds TCPAP ... Two times larger than apnea backup preset ventilation volume, or for 5 seconds @100% O2 button Regardless of the preset oxygen conc., ‘100% O2' supply continues for ‘2 minutes’. # A prescribed time is required until the oxygen conc. within the main unit's reservoir reaches ‘100%’. Suolounj *p uol}sodwog jeueg yuo! y ESsuoljoun4 P Uol}sodwog jaueg 01 48 Ree a Saal Ole ucry @ Circuit pressure gauge Measures/reads patient circuit pressure. 8Circuit pressure indicator Measures patient circuit pressure, and the result is digitally shown. @Selector buttons (for circuit pressure display) The patient circuit pressure's ‘Maximum’, ‘Plateau’, ‘Average’ or ‘Expiratory end’ can be shown in the circuit pressure indicator by means of switching. If the ‘ON’ button for each measurement value is pushed, the corresponding result is displayed in the indicator. @ Circuit pressure alarm preset bar graph Measures patient circuit pressure, and reads it graphically. In addition, the alarm preset value preset by the ‘Low inspiratory pressure alarm preset’, ‘Excess pressure alarm preset and ‘Circuit pressure alarm quick preset’ buttons, and when an alarm has activated, its preset value blinks on the LED bar graph. @Low inspiratory pressure alarm preset button The ‘Low inspiratory pressure’ alarm can be preset in the range of ‘2~60hPa’ by mean of its ‘+/-’ preset buttons. @Excess pressure alarm preset button The ‘Excess pressure’ alarm can be preset in the range of ‘10~70hPa’ by mean of its “#/-' preset buttons. Both ‘Low inspiratory pressure alarm’ and ‘Excess pressure alarm’ levels should be’ preset each to a numerical value near to the maximum inspiratory pressure. Preset carefully «If the ‘Low inspiratory pressure’ is set to a too low! level, an alarm won't activate even when leakage from the respiratory circuit has been incurred. #|f the ‘Excess pressure’ is set to a too high level, a pressure injury to the lung might be caused.@Circuit pressure alarm quick preset button Pushing this button allows for one-action presetting of 'Low inspiratory pressure’ and ‘Excess pressure’ alarms Alarm's quick preset value: Low inspiratory pressure ... Actually measured maximum inspiratory pressure - 5hPa Excess pressure ... Actually measured maximum inspiratory pressure +10hPa While ‘Low inspiratory pressure’/Excess pressure’ alarms are in action, alarm presetting by the ‘Circuit pressure alarm quick preset button’ is not available. AAV CUCU amano ielm aut) @Ventilation volume/ respiratory rate indicator Reads actually measured ventilation volume, When an alarm has activated, and in case of an abnormality occurrence, the relevant ‘error code’ lights in red to inform of the cause of such an unusual happening. # When the power has been turned on or the expiratory valve unit has been replaced, the tidal volume might be shown sometimes in a less value provided that the expiratory valve unit has cooled down. Connect surely. (The ‘Respiratory circuit’ should be connected with certainly. If connected imperfectly, gas leakage may be caused. Further, it is also apprehended that correct Connect securely ventilation volume might become not obtainable.) (vote) referring to the ‘Error code’ section in the [F] Alarm area. suoljouN4 @ UO}}IsodWog jaued wo. 4-9Ss s e a © 5 = o Ss a 410 @Selector buttons (for ventilation volume/ respiratory rate display) With these three buttons, the ‘Ventilation volume/ respiratory rate indicator’ can be switched among ‘Tidal volume’, ‘Minute ventilation volume’, and ‘Respiratory rate’ As regards ventilation volume, the patient's expiratory volume is measured by the expiratory flowmeter within the expiratory valve unit. “Tidal volume’: Every expiratory volume is measured and displayed. ‘Minute ventilation volume’: The minute ventilation volume which is calculated based on the current expiratory volume and the previous two values of expiratory volume, is displayed. ‘Respiratory rate’: Actually measured respiratory rate is displayed. Unless any selector button is pushed, the indicator shows ‘tidal volume’ as default. Meanwhile, when either selector button (‘Minute ventilation volume’ or ‘Respiratory rate’) has been pushed to show relevant. value, the display automatically returns, in 30 seconds, to ‘Tidal volume’ indication. @inute ventilation volume alarm preset bar graph ‘The measurement value of ‘Minute ventilation volume’ is graphically shown. In addition, the minute ventilation volume alarm preset value preset by the ‘Minute ventilation volume alarm lower limit preset’ and ‘Minute ventilation volume alarm upper limit preset’ buttons, is shown and lit on the LED bar graph. While an alarm is activating, the alarm preset value blinks on the LED bar graph. # The minute ventilation volume shown on the LED bar graph is an actually measured value, and this value is calculated based on the current ventilation volume and the previous two values of ventilation volume. @Minute ventilation volume alarm lower limit preset button The lower limit of ‘Minute ventilation volume’ alarm can be preset in the range of “1~28L’ by means of /-’ buttons. Minute ventilation volume alarm upper limit preset button ‘The upper limit of ‘Minute ventilation volume’ alarm can be preset in the range of ‘S~30L' by means of ‘+/-’ buttons. @ Quick preset button Pushing this button allows for one-action presetting of ‘Minute ventilation volume’s upper} lower limit’ alarm. Alarm’s quick preset value: Upper limit ... ‘150%! of actually measured minute ventilation volume. Lower limit ... ‘70%’ of actually measured minute ventilation volume While ‘Minute ventilation volume’ alarm is in action, alarm presetting by this quick preset button is not available.[F] Alarm area @Alarm indicators Ifan alarm activates with simultaneous sound, and the relevant alarm indicator blinks. In such an event that the alarm in action has been canceled due to the patient's improved condition or alteration of the alarm preset value, the blinking indicator switches to ‘lit, accordinaly, allowing for confirmation of the alarm which has happened. After cancellation, this lighting continues for ‘one minute’ (except ‘Improper setting’ alarm). During this one-minute lighting, should a new alarm has been incurred, the prescribed indicator blinks. a) Circuit pressure alarm If ‘Low inspiratory pressure’ or ‘Excess pressure’ alarm activates, the ‘Circuit pressure indicator’ blinks with simultaneous sounding. At the same time, the numerical value preset on the ‘Circuit pressure alarm preset bar graph’ as well blinks with a sounding. After_alarm cancellation, if the blinking ‘Circuit pressure indicator’_has changed to ‘lit, the alarm preset point on the bar graph continues to blink for ‘one minute’ until the ‘Circuit pressure indicator’s’ ‘lit’ condition comes toan end. a-1) ‘Low inspiratory pressure’ ..... Activates in such a case that the preset level is not reached due to coming-off of intratracheal tube or leakage from the circuit. Up to the ‘2nd time’ of this alarm occurrence, the preset point on the ‘Circuit pressure indicator’ and the bar graph ‘blinks’, and if this alarm continues for the ‘3rd time’ or more, the same preset point blinks with simultaneous sounding, 2-2) ‘Excess pressure’ ..... Activates if the preset point on the bar graph has been exceeded, and at the same time the inspiratory phase is switched over to that of expiration. Up to the ‘ist time’ of this alarm occurrence, the preset point on the ‘Circuit pressure indicator’ and the bar graph ‘blinks’, and if this alarm continues for the ‘2nd time’ or more, the same preset point blinks with simultaneous sounding. # In the CPAP mode, should an apnea backup have activated, the backup ventilation volume is prioritized, accordingly, this ‘Excess pressure’ alarm function won't be activated, in other words, the inspiratory phase is not switched over to that of expiration. SUO!JOUNY *P UO!}IsodwWog jaueg jUO14 ES 4-11b) Ventilation volume alarm When the upper limit value preset on the ‘Minute ventilation volume alarm preset bar graph’ has been exceeded, or the lower limit value has been fallen below, the ‘Ventilation volume/ respiratory rate indicator’ blinks with simultaneous sounding. After_alarm cancellation, if the blinking ‘Ventilation volume/ Respiratory rate indicator’ has changed to ‘lit’, the alarm preset point on the bar graph continues to blink for ‘one minute’ until the ‘Ventilation volume/ Respiratory rate indicator's' ‘lit condition comes to an end. ¢) Apnea alarm In the SIMV Pressure Support mode (preset respiratory rate, ‘4 times/min’. or less) or in the CPAP mode, if the patient's spontaneous breathing doesn’t reach the trigger level within the standby time (30 seconds), the ‘Apnea indicator blinks with simultaneous sounding. When this ‘Apnea’ alarm has activated, a backup ventilation starts with the respiratory rate of ‘5 times/min.’. ) Power failure alarm If the main power (100~240VAC) supply is interrupted, the ‘Power failure indicator’ blinks with simultaneous sounding. At the same time, your ART-21EX ventilator operation is switched to powering by the internal battery. Start using the unit after checking proper activation of ‘power failure’ alarm as well as the remaining capacity of the backup @ ‘internal battery’. (if the unit is used with the battery's capacity little left, in Suol}oUNY *Y UOIyISodwWOg jaueg JuoLY ES Confirm in advance emergencies such as power failure, the length to allow unit operation with the battery gets shortened. Besides, it caused to shorten the battery life as well. Confirm the remaining capacity periodically, and if it is not fully charged, full charging is required.) # While the ART-21EX is in use, this battery is charged at all times. Should the ‘Power failure’ alarm not active, have Z\ Warming your unit ‘overhauled or repaired’ by an Acoma authorized service station. Ask for repaire) AIR/O2 pressure alarm While measuring the flow rate of the gas in use, if it deviates from its appropriate use range, the ‘AIR pressure indicator’ (or, ‘O2 pressure indicator) blinks with simultaneous sounding. # As a substitute for traditional pressure monitoring system designed for use in piping facilities (for instance, using a pressure switch), this device keeps watch on the gas flow supplied to the main unit. For use in the in-hospital piping facilities, the applied AIR/O2 pressure should be in the range of '350~500kPa’. + If ‘AIR pressure’ alarm activates due to the pressure running short, operation is backed up by ‘Oz’ in place of ‘AIR’ (provided that 'Oz' pressure tube is connected to a piping facility or an ‘O2' cylinder). + If ‘Oz pressure’ alarm activates due to the pressure running short, operation is backed up by ‘AIR’ in place of 'O2' (provided that ‘AIR’ pressure tube is connected to a piping facility or an ‘ART-218'). f) Improper preset alarm In the following three cases, the ‘Improper preset indicator’ blinks with simultaneous sounding. (After alarm cancellation, however, the indicator doesn't switch to ‘lighting’.) + For apnea backup ventilation in the VCV and CPAP modes: Activates if the flow rate has gone beyond the range of '5~80L/min.’. + In the PCV mode: Activates if the preset inspiratory time (+0.5 sec.) has exceeded. the time of one respiration. + In the SIMV Pressure Support mode: Activates if the flow rate has gone beyond the range of ‘5~80L{min., or if the preset inspiratory time (+0.5 sec.) has exceeded the time of one respiration. @alarm pause button When ‘Circuit pressure’, ‘Ventilation volume’, ‘Apnea’, or ‘Power failure’ alarm is in action, pushing this button allows to mute alarm sound for '2 minutes’. During this pause, the display of the relevant alarm indicator (Fig.11 on p.4-11) blinks. Alarm sound recovers automatically in ‘2 minutes’. Meanwhile, if this button is pushed again during the pause, the starting point of muting is reset, namely, starting from this very moment, the pause continues for ‘2 minutes’. # Regardless of the alarm activation, this button serves to mute alarm sound for ‘2 minutes’ starting the point of pushing. @alarm sound recovery button If this button is pushed during the alarm pause, the mute state is cancelled. @Battery-in-use indicator The power supply (100~240VAC) from the main source is interrupted, the unit drive switches to the internal battery. Then the ‘Battery-in-use indicator (Fig.11 on p.4-11) blinks to inform that the built-in source is being used. At the same time, the ‘Battery remaining capacity indicator’ (Fig.11 on p.4-11) as well lights. sUOlOUN4 9 UOlTIsodWOg jaueg jUO4 ES 4-13Od WON jaued 01 414 @Battery remaining capacity indicator Coincidentally with the blinking of ‘Battery-in-use indicator, this indicator lights. (Fig.12) The remaining capacity of internal battery is shown by the 4-step indicator lighting as follows: a) When all the four steps are lit, it means that the battery is fully charged, viz., 100% capacity available. b) The first step goes out: The full capacity’s 50% consumed ©) The first/second steps go out: 70% consumed 4d) The first/secondithird steps go out: 90% consumed © wa oo | (Full charge) (90% consumed) When the remaining capacity has reached the state of 90% consumed, the power failure alarm activates | Fig 12) again, informing that it is reaching the level of ‘0’. Should the remaining capacity have reached ‘0’, an alarm only sounds, and the ventilator main unit stops operation. When driving the unit with the internal battery, standard operability is approx. ‘30 minutes’, but depending on the state of battery charging, or because of the battery deterioration caused by across the ages, this standard ‘30-min.’ drive might not be maintained in some cases. The battery is charged while the main unit is operating, and it takes more than approx. ‘7 hours’ to charge from the remaining capacity of ‘0’ to ‘full charge’. If the main unit hasn't been used for an extended period of time, available voltage of the internal battery might have lowered due to automatic discharging. Accordingly, confirm the battery's remaining capacity ‘once every three months’ by attaching the test lung, and if not fully charged, immediately charge the battery. # While driving the main unit with the internal backup battery, the following auxiliary units won't function, in other words, each operation cannot be backed up by the battery: ‘Nebulizer’, dedicated blower ‘ART-21B’ ‘Heater-humidifier’, and the expiratory flowmeter’s ‘Heater (for prevention of waterdrop sticking)’. # Be forewarned that ventilation volume might not be sometimes shown properly while the main unit is driven by the internal battery.. For provision against power failure, make Z\ warming sure that O2 is connected to ART-21EX @ main unit at all times. (Unless O2 is connected, in power failure, the optional Connect O2 always edicated blower ‘ART-218' won't function at all because it is not backed up by the internal battery. In such an event, Or supply can act as substitute to continue blower drive. For this reason, O2 connection is a must.) Unless AC power source is available, Z\Waming applicable functions are limited. @ (The ventilator’s control section only can be driven by the backup battery, so ‘Nebulizer’, ‘Heater-humidifier and dedicated blower ‘ART-21B’ won't function with this Funetional restriction battery.) NEVER use ART-21EX being operated with the backup battery, for the purpose of patient transportation. Don't use (The internal battery's purpose is only to back up power in case of emergencies such as AC power interrupted due to power failure, to continue ventilator operation for a limited duration until the main AC source is recovered. Accordingly, an ART-21EX while it is battery operated, should not be used for, for instance, transporting the patient from ward to ward.) . If battery-operability has become extremely A\ Caution short, or every ‘two years’ use, replace the Oo battery with a new one. % (This means that the battery is deteriorated due to across Replace with a new one the ages. Replace it with a new one.) # Battery life is approx. ‘two years’. SUOIJOUNY Y UO}IsodWOD jaued wo 45Suo}OUN *y UOIIsodwWOg jeued v0 4-16 Error codes In addition to alarms, should any abnormality have been incurred in terms of various functions incorporated in the ART-21EX, relevant error codes are shown on the ventilation volume indicator — ‘E1’, ‘E2,,...... in re [Meaning of each error code & remedial measures] [E1}: Abnormal O2 flow Cause — @ The Oe flow supplied to the main unit has gone down, or an excessive flow is. supplied @® Without Ozconnection, the main unit's oxygen conc. has been preset to over ‘2190 Remedy — @ Confirm that Ozis connected securely ® Confirm that O2 supply pressure stays within the range of '850~500kPa’ @® Replace Oz cylinder with a new one [£2]: Abnormal AIR flow Cause — @ The AIR flow supplied to the main unit has gone down, or an excessive flow is. supplied @® Dedicated blower ‘ART-21B' has turned down in ability Remedy — ® Contirm that AIR source is connected securely ® Confirm that the pipeline AIR supply pressure stays within the range of "350~500kPa’ @ Replace the blower with a new one [E3]: Abnormality in main unit's drive pressure Cause — Main unit's drive pressure cannot be maintained, or the pressure is too high Remedy ~ @ If minute ventilation volume is near to the main unit's performance limit (30L), let the volume down, @ Confirm the pipeline’s pressure. (50~500kPa) # Should the above three error codes — [E1] ~ [E3]— appear at frequent intervals, ask for inspection/repair to an Acoma authorized service station. IES]: Abnormality in inspiratory flowmeter Cause — There's a difference between the calculated inspiratory flow and that actually measured using the inspiratory flowmeter. Remedy — Since the main unit is driven with a fixed inspiratory flow, the ventilator itself won't stop operation, but correct preset ventilation volume might become obtainable in some cases. # Should this code appear lastingly, ask for inspection/repair to an Acoma authorized service station.[8]: Abnormality in-circuit pressure sensor Cause — The sensor's zero point hasn't been adjusted properly, or the sensor is defective Remedy — Ask for inspection/repair to an Acoma authorized service station. [E9}: Abnormality in expiratory flowmeter Cause — Expiratory flowmeter abnormally detects flow rate. Remedy — @ Make sure that no waterdrop is collected in the expiratory flowmeter within the expiratory valve unit. f any, immediately eliminate accumulated waterdrops. @® Should this code continually appear even after making the expiratory flowmeter sufficiently dry, ask for inspection/repair to an Acoma authorized service station [E10]: Abnormal temperature within the expiratory valve unit ‘Cause — Abnormal temperature rise due to defective heater within the expiratory valve unit, or defective temperature sensor. Remedy — Ask for inspection/repair to an Acoma authorized service station. [E11]: Improper calibration of inspiratory flowmeter zero point Cause — Periodical inspiratory flowmeter zero point calibration hasn't been carried out properly. Remedy — Even if this code has appeared, there's no problem in terms of operation because conventional normal zero point calibration value is maintained. Ask for inspection/repair to an Acoma authorized service station. [E12]: Improper calibration of expiratory flowmeter zero point Cause — Periodical expiratory flowmeter zero point calibration hasn't been carried out properly. Remedy — Even if this code has appeared, there's no problem in terms of operation because conventional normal zero point calibration value is maintained, Ask for inspection/repair to an Acoma authorized service station. [E13]~[E15]: Abnormalities in CPU Cause— Because of some abnormality, microprocessor doesn't function normally. Remedy- Ask for inspection/repair to an Acoma authorized service station. suoljoun4 »9 u 417MEMO[Ei vrive CircuitynouIg aALig Ea 5-2 Drive Circuit (Fig.13) 1 [Ozgasiniet_ [41 | Proportional control valve 2 | O2 pressure-reducing valve [12 | inspiratory flowmeter 3_| Oe solenoid valve 13 | Emergency AIR intake valve 4_| Oe flowmeter 14 [Inspiratory port 5_| AIR gas inlet 15 | Nebulizer port 6_| AIR pressure-reducing valve 16 | Nebulizer pump 7_| AIR one-way valve ___| [47 [Bacteria filter 8_| AIR solenoid valve 18 | Heater-humidifier 9 [AIR flowmeter 79 | Nebulizer cup 10 | Gas reservoir 20 | Nebulizer filter 24 | Expiratory valve unit 31 | ART-21B dedicated connection port 22 | Expiratory port ‘32 | ART-218 dedicated one-way valve 23 | Auto drain water level audit window | [3 | ART-218 (optional) 24 | Expiratory valve actuator 34| Blower | 25 | Circuit pressure transducer | 26 | Expiratory flowmeter 27 | Expiratory valve unit heater = 28 | Exhaust port _ 29 | Circuit pressure gauge 30 [Auto drain actuator[Primary gas flow] + Through the Oz gas inlet @, Oz enters the main unit, and then after passing through the Pressure-reducing valve @) and Solenoid valve @), it is stored within the Gas reservoir (0. + The AIR (or, that which entered the main unit from the ‘ART-218' dedicated connection port @) passes through the AIR gas inlet 6) and pressure-reducing valve ©, and is stored in the Gas reservoir @® after passing through the Solenoid valve ®). + These O2/ AIR are measured by the Flowmeters @, © so that their Oz cone. be- comes that preset on the control panel, and then are sent into the Gas reservoir 40. + When the Proportional control valve @) is opened, the gas accumulated in this, reservoir is sent to the patient, following the ventilation condition preset on the control panel, via the Inspiratory flowmeter 2, Bacteria filter @D. * When using the Heater-humidifier (®, connect it within the portion encircled in Fig.13 by a dotted line (viz., between the bacteria filter on the inspiratory side and the Patient) {Circuit pressure monitoring] On the basis of the pressure taken in from the Expiratory valve unit@, the patient circuit pressure is shown in the Circuit pressure gauge @ on the control panel. [Tidal volume] * When controlling tidal volume, the gas flow sent out from the Proportional control valve @) is measured in the Inspiratory flowmeter @, and it is fed back to the proportional control valve so that this ventilation volume becomes as per preset. + Inspiration/expiration switching action is controlled by the incorporated CPU. [Expiratory valve unit] + The Expiratory valve unit @ serves to hold down the diaphragm in the inspiratory phase with the aid of the Expiratory valve actuator @ so that the patient circuit is set into a closure state with an approx. 70hPa pressure. + In the expiratory phase, the expiratory valve's diaphragm is held down by the Expiratory valve actuator @) so that the preset PEEP pressure becomes available, therefore, the circuit is closed. During this process, the expiratory gas from the patient side is let go from the Exhaust port 8 in order to maintain PEEP to a fixed level + The expiratory gas is measured in the Expiratory flowmeter @8, and displayed on the control panel. * The water collected within the unit is automatically exhausted out of the expiratory valve unit at prescribed intervals (every 30 minutes). + This expiratory valve unit is kept warm (approx.40°C) by a built-in heater @. noal9 aA fo |[Nebulizer] + Pushing the nebulizer ON/OFF button on the control panel serves to nebulize medicinal liquid in synchronization with inspiration. + In the inspiratory phase, a part of the gas sent out from the Proportional control valve @ is pressurized by the Nebulizer pump (® to nebulize medicinal liquid within the Nebulizer cup @®, and this mist is sent out to the patient. + Due to utilization of the gas in the inspiratory circuit as mentioned above, no change is caused in tidal volume as well as Ozconc. [Circuit constant flow] + By means of opening the Proportional control valve @), a constant flow of trigger sensitivity + SL/min. is formed within the patient circuit (provided that assistor ventilation is set to ‘ON’). Due to this gas flow, an inspiration can be realized without feeling almost any delay. + The patient's inspiratory flow is detected by the flow decrease in the Expiratory flowmeter®, and if the preset flow trigger level has been reached, assistor (or pressure support) ventilation is carried out in no time. + By means of a combined application of circuit constant flow as well as flow trigger system assistor (or pressure support) ventilation, the patient can inhale a sufficient volume of gas continuously. * Circuit constant flow is so devised that it starts to flow from the moment when the phase has been switched to expiration. * While assistor ventilation is set to ‘OFF’, circuit constant flow is flowing with the rate of approx. 2L/min.| eo Pre-use Preparations/ Operational Checks [1] Preparations [2] Operational ChecksSyoayQ [BuOHeJedQ/suo|esedalg asn-alg | | 6-2 Pre-use Preparations/Operational Checks [1] Preparations Make sure to perform operational checks according to A\ Caution the ‘Pre-use, During-use and After-use Checkup Items’ Items’, @ (Carry out inspection, folowing each inspection table, ‘Preparatory Inspect check] Pre-use operational check’, ‘During-use check’ and ‘After-use check This is extremely important to ensure unit's normal operation as wall as safety fr the next use.) When moving the main unit, be careful for the following : @ Remove all the units/device placed on the monitor @ shelf (optional); @ Unlock the castors; Careful handli z . aretul handling @ Hold the handle on the main unit's front; @ Pay attention to the difference in level on the floor; and, © Move the unit in a single direction (to the front or to the rear). {Ifthe unit is moved with the castors locked or forcibly, it might cause injury due to unit fling down or damage tothe product ) +# Horizontal(to lefitight)movement of the unit might cause it to be fallen down. (1) Fitting Supporting arm — Optional monitor shelf not mounted: 1) Insert the ‘Supporting arm’ into the ‘Arm fixing fitting’ on the main unit's rear. 2) Set the arm in a desired direction, and tighten the “Asm fixing screw’ by turning it clockwise. ‘Supporting arm’ position /\ Caution should be changed after loosening the levers. ‘Supporting arm ‘Arm fixing, screw Ct) (Should a forcible position change Arm position _with the levers locked be attempted, it might cause unit falling-down or ‘Arm fixing damage to the arm.) fiting (fie14)