AU2013216679A1 - Method and system for controlled infusion of therapeutic substances - Google Patents

Abstract

A method for infusing arnifusate into the body of a human or animal subject using an inftuson profile which has the following steps: A) assigning () total infusate volume; ii) total number of infusion steps; iii) time duration per infusion step, iv) maximum infusion rate, v) initial fusion rate, vi) incremental increase in infusion rate and vii) ramp rate; B) calculating a first infusion step having 1) a ramping segment and ii) a terminal segment; C) performing the first infusion step at approximately the assigned initial infusion rate until the assigned time duration has been reached; D) calculating a volume of infusate delivered during the preceding infusion step; E) calculating the remaining volume of infusate to be infused to deliver the assigned total infusate volume; F) cakulating an additional infusion step based on the incremental increase in infusion rate, remaining volume of infusate to be infused and the volume of infusate delivered during the preceding infusion step, the additional infusion step having i) a ramping segment and ii) a terminal segment; G) performing the addiional infusion step which continues at approximately said new infusion rate untit the assigned time duration has been reached; and H) repeating Steps D through G until the assigned total infusate volume has been delivered,

Description

Regulation 3.2 Revised 2/98 AUSTRALIA Patents Act, 1990 ORIGINAL COMPLETE SPECIFICATION TO BE COMPLETED BY THE APPLICANT NAME OF APPLICANTS: Baxter International Inc. Baxter Healthcare S.A. INVENTORS: MOUBAYED, Ahmed-Maher HYMAN, Oscar E WHITE, David N WILSON, Larry L STEVENSON, John W MOUBAYED, Jay G THOMAS, Linda ADDRESS FOR SERVICE: Peter Maxwell and Associates Level 6 60 Pitt Street SYDNEY NSW 2000 INVENTION TITLE: METHOD AND SYSTEM FOR CONTROLLED INFUSION OF THERAPEUTIC SUBSTANCES DETAILS OF ASSOCIATED APPLICATION NO(S): Divisional of Australian Patent Application No. 2012 201 077 filed on 18 September 2007 which is a divisional of Australian Patent Application No. 2007 299 900 filed on 18 September 2007 The following statement is atfull description of this invention including the best method of performing it known to us: mAdocs\20071207\295283.doc METHOD AND SYSTEM FOR CONTROLLED INFUSION OF THERAPEUTIC SUBSTANCES 5 FIELD OF THE INVENTION The present invention relates general to medical devices and methods and more particulady to pgrammable infusion pump systems and their uses in the treatment of media dorders. BACKGROUND OF THE INVENTION 10 Various types of prgrammable infusion pumps have bean used to deliver controlled Infusions (e4Intravenous infusions, epidural nfusaions, subcutaneous infusions, enteral infusions, etc ) to patients in hospital and out-of-hospital stngs. Pgrammable Infusion pumps arm used to administer a wide range of drugs, bloogloa therapies and other substa , Includng but not lmited to 15 cancer chemotherapy, analgesic medications, Immune Globuln therapy, insulin, etc. Prgrammabie infusion pumps typicafly Include safety frats that control or imit the rate of infusion and the amount of solution daleed to the patient thereby prevening inadvertent overdosing, underdosing andfor infusion rate related side effects. Some programmable infusion pumps aLso include other 20 safety features such as automated alr4rnline detectors, etc, These types of safety features are t typically available wth non-programmabe pumps or hang intravenous drips. The infusion pump systems of the dor art have included varying degas of programmablity and/or automation. Examples of infusion pump systems that 25 are programmable and/or have some degree of autonaton Include, but are not limited to, tho described in United States Pateni Nos 4,670,007 (Wheeldon at al); 4,978,335(Arhur, 111); 4,976,151 (Mohita); 4,858,339 (Wiffiams); 5,256,157 (Samiotes, at al); 5,756,327 (Sasanfar, at at); 5683,307 (Jordan, et a14; 6,269,340 (Ford, et al,); 6,854,620 (Ramey) and 6,059,980 (Moberg, et al,) as well as United Sats Patent Aplication Publican Nos, 20040019607 (Moubsyed at al) and 2004/0172283 (Vanderv en at at) One particular use for prgrammable infusion pump technology is In the 5 adminisration of Immune Globulin (Ig) therapy. Immune Globulin may be infused inrvenously (eIgw, Inven Immune Globulin (IVIG) Therapy) or subcuaneously (eg. Subcuaneous Immune Globulin (S0G) erapy), immune Globuin t pies have been used to great primary Imunodefcencies (e.g., ongenital agmmaglebulinemla, hypogammagobulinmIa, common variable 10 munodefciency, X-inked immunodeficiency with herimmunogiobulin M, ever mbined immunodefliency (SCID) and Wiskot-Aldrich syndrome), Ao, IMG therapy may be used in the treatment of Kawasaid Syndome, B-Cell Chronic Lymphcy Leukemia, Idiopathic Thrombocytonic purpure (TP), acute graft-versus-host disease associd aterstItial pneumnia (infectious or 15 idiopathic) after bone manw transplantation (BMT), human immunodiiency virus (HIV), as a treatment for Acute GuIain-Bargt Syndrome, refrctory dermatomyosIs, hpertmmunogibbulinem4a E syndrome, Lambert-Eaton Myasthenic Syndrome, RelapsiOng Rsmitt Multiple Sclerosis, Parvovis 819 Infectn and associated anemia, Chronic iamatory Demyenating 20 Polyneuropathies, Multifocal Motor Neuropathy (MMN), ntious diseases, adreaisukodystrophy, acquired Facor VIl inhibitors, acute iymphoblastic leukemia, anemia, autoimmune hemolytic anemia, aplastic anemia, diamond Blackfn anemia, Aplasia, Pure Red Ce anemia, athma, Infarmatory ches disease, Behets syndrome, chronic fatigue syndome, clostridium difficile toxin, 25 congenital hear block, cystic fibrosis, intractable pediatric epilepsy, juvenile arthrIts, myosits, POlymyoi'is, multiple myeloma and Immunoprofeive neoplasms, MOr neuron syndromes, myasthenia gravis, myalopathy associated with Human T-ce leukemiallymphoma virus,, nephroic syndrome, membranous neuropathy, Paraproteinemic neumpathy, euthyroid 30 opthalmpathy, current otitis media, pemphigus vulgaris, pemphus faaceus, 2 paraneoplastic pemphigus, progressive lumbOsacral plexopathy, post-transfusion purpura, current fetal loss, renal failure, rheumatoid arthritis, systemic lupus erematosus and relatd na nephritls, CNS involvement vasculhtir podcardits, or pleural effusion, thmbto thrombocytopen purpura, 5 nonimmune thrombocytopenia, neonatal aoinmune thrombytopenia (pre- and postnaalkseptic thrombocyiopenla, quinine induced thrombocytopena, transfusion matons, uvetis, systemic v ulitic yndrmne, acquired Von Wlebrand's snrome and others. Immune Globulin infions must be carefuy presried and administered, 10 IVIG sfusions are often adminislered by an infusion protocol whreby t rate of fusion is Increased in a step-wlw fashion, Prior to each increase in the infusion rate (eig., each "ste up),the patient is monitored for sIgns of advere reaction, If no advr reaction is noted and the patient appears to be tolerating th infusion, then the infusion rate Is increase (eg,, stepped up) The tys of 15 adverse reaction that may occur as a esult of MG infusion include migrane headache, flushing, nausea, vomiting, chills and others, There Is also a risk of more serious, sometimes lifethreatening reactions, for example, rik of thrombus formation. Particular care must be given to patient having certin health issues such as a history of stroke, heart attack, blood vessel disease, IgA or IgG 20 deficIencies or blood clots. With the heightened emphasis on cost-sfaectiveness and wet-containment In health care, hore infusion therapy is becoming Increasingly commonplace. Home infusion therapy generally involves t administration of mediadons, for example, Immune Globulin infusions using Irvenous, or subcutanus routes, 25 in the patient's home rather than in a physician's office or hospitaL Infusion therapies in the home are typiay administered by a home health care worker having some training in the operation of infusion equipment and the administration of biology therapies, but In some cases may be administerd by a patient himsek. Thus, it can be appreciated that there Is a need for systems end 3 methods that incorporate careful monitoring of patient reactions and vital signs during administration of infusion therapies, for example, IVIG. Other particular uses for programmable nftusion pumps include, but are not limited to, th administrat n of analgesics, anhetics, cancer chmotherapy, antibiotic, gene therapy agents, ani-venoms and other das or substances that ulre carefully controlled and/or monitored Infusion to avoid harmful reactions, overdosing, allergic responses, anaphylactic responses, other idiosyncratic responses, etc. There remains a need in the art for the development of now 10 programmable infusion systems that provide for Improved Infusion control and sympto/side effect monitodag dudng an or after the Infusion. SUMMARY OF THE INVENTMO In accordance with the present inntion there is provided a system for administering a substance to a human or non-human animal subject. In general, 15 this system comprises a) a pump, b) a substance administration conduit for deliverng the substance to the subjects body, c) a subject database containing information on at least one human or norvhuman animal subject and d) a contrier that is in communication with the pump and Issues cctl signals to the pump, such controller being adapted to access information on the subje 20 from the sject infoaton database. The subject databse may contain various types of Information that is specific to each human or anim subject, including for example; nam, address, age, boy weight, medical history, a list of other medications rceivd, alargies, reaction(s) to previous infusions, preferred vascular acow site(s), presadptions for substances to be infused, etc. In some 25 embodimrents, t subject database may include information obtained from personal responses provided by the subject rerdn his/her reaction to the current or prior infusions of the substance, In such embodiments, the system may include apparatus for posing quedes to the subject and for lving/storing the subject's response to such queries, Altematively or additionally, in some 4 embodiments, the subject database may include infanation obtained by monitoring the subjects body or physiologic responses to the curnt or prior infusions of the substance in such em boiments, the system may include apparatus (ea. a feedback lop) for mnitoring badly or physiologic vadable(s) 5 that are potentially indicative of the subjects bly and or physiologic responses to an Infusion (e.g. heart rate, blod pressure, body temperature, respiratory rate, oxygen saturation, galvanic skin response airwy resistance, etc.) and for receiving/storing information relating to cang In those monitored vaIables. Further In acordae with the invention, the abve-summadzd system to my optionaly include a substance database that contains infbrnain on at least one substance the system may administer to subject(s). In embodiments that include the substance database, controller may be fu rher adapted to access substance information from the substance database. The substance database may contain one or more refined, substancespefl infusion 15 protocols that may be used for administration of a particular substance and/or other types of information on specft therpeuic substances (eg., doge infoation, recommended infusion rate information, substance-substance loteations, known side effects or adverse rectns, etc.) on vadous substnce(s) (eg., drugs a blogics, etc.). In some embodiments, the substance 20 database may group substance Information by category (e.g, therapeutic categies, drug categries, etc.). Optionally, the system may incorprate a user interface (e.g., a keyboard, touch screen, voce recognition or other data input apparatus) or may have a hard wired or wireless connction to a separate data Input apparatue or data storage device (eog , a wired or wireless network, a 25 pernai Computer, Peral digital assistant, Iptop computer, disc drive, USS lash drive, etc.) whereby substance-specific infusion protocols or other substance infontion may be transfemed (eg loaded) to and stored by the subsnce database. In this regard, a user may create one or more prescdbed infusion protocols for a particular substance ad may then manuagly input or 30 download those custom made, substance-spcific infusion protocols to be stoed 5 in the substance database in connection with the particular substance to which they pertain. Sti further in accordance with the invention, the abve-smmarIz system may optionaly include an infusion database containing infusion $ inmiation (e.g, generic or preefined fusion parameters or prtocols that are not specific to a particular substance) and the controller may be further adapted to accs infusion praomtr infonnation from the InfusIon databso. The sion database may contain various types of Infusion informatn including, for exampe, a vadety of prest infusion protocols, specific nfusion Parameters 10 (eg, rate(s volume(a) an time(s) The term infusion prtocor" as used herein refers to a sedes of pu control instructions that control some or al of the fonowing rate(s) at which the pump will infuse the substance, wen changes) In infusion rate wlfl ocr, the volume of infusate to be infused the duration of infusion, the infusion profile, ft Infusion schedule, etc In some cases the 15 infusion protocol may be a steopise protocol whetin the substance is infused at a first rate for a first infusion perod (eig, a pedod of time or untl a predtenmined amount of the substance has been delivered) then to change to a send flow rate for a second infusion period. This may repeat for one or more subsequent infIon perids (eg the total number (n) of infusion periods may be 2 or more). 20 in other cases the infusion protocol may provide for continual rse ndor decrease of the infusion rate (elg., a continuous ramp up and/or down) rather than changing infusion rates at discrete pnods as in the step-wis8 protocol, These and other aspts and advantages of the present invention are apparent in the fillowing detailed description and claims, particulary when 25 considered in conjunction with the following drawings in which like parts are identified by like reference numerals. 6 BRIEF DESCRIP'iDN OF THE DRAWINGS Figure 1 is a general diagram of an infusion system of the parent invention. Figure 2 is a diagram of one embodiment of an infusion system of the 5 present invention useable to administer MG therapy and other biologic therapies. Figure 3 is a diagram of various databases and records that may be Incorporated into or accessed by an infusion system of the present invention. Figure 4 is a flow diagram of a method for creating and storing a new 10 infusion protocol to be used by an Infusion system of the present Invention. Figure 5 Is a flow diagram showing alternate methods that may be used for selecting and optionally modifying an infusion potocl to be used by an sion system of the present invention. Figure 6 is a flow diagram showing an embodiment of of Pt resent 1i invention wherein an infusion system is used to administer an infusion to a patient while monitoring te patients response to such Infusion, Figure 7 shows an example of a home menu that may be displayed by an infusion system of the present invention. Figure 8 show an example of a standby menu that may be displayed by 20 an infusion system of the present invention. Figure 9 shows an example of an Rx summary menu that may be displayed by an infusion system of the pen Invention. Figure 10 shows an example of a select Rx menu that may be displayed by an infusion system of the prsent invention. 7 Figure 11 is a graph of Infusion Rate v, Time, showing an example of an MG Infusion profile that may be delivered using an Infusion system of the present invention OOTALEO ONSORION OF THE INVENTION 5 The following dated description and the accompanying drawings are intended to describe some, but not necessarily all, examples or embodiments of t inventionr The contents of this detailed description and the accmpanyng drawings are not necessarily alknclusive and do not imit the spe of the invention in any way. 10 Fgure I show the programmable infusion system 10 of the presnt invention, In this example the system 10 generatly comprises an infusion pump 12, an infusat-ntaining vesse 16, an infusion conduit 18, a controaer 14 for controlling the pump, a dala storage medium 20 accessibe by the controller 14. The data storage medium 20 is useble for storage oft end access to, one or 15 more databases such as a substance protocol database 22 and/or a subject protocol database 24 and/or and infusion protocol database 26 and/or a substance reference library 40 and/or system configuration parameters 41and/or a history file 43. In embodiment that include a substance refernce library 40, such substance reference library 40 may be a separate database or may be 20 inoorated as part of the substance proto database 22. In addition, system 10 may incude one or more interfacing devices) 28 (eg.,a personal computer 20a, USS flash memory drive 28a, personal digital assistant (PDA) 28b, barcode reader 28c, and/or telephony modem) ac ble to controller 14, Further, a user interace device 30 (e4, touch san, mouse, 25 keyboam, voice recognition system, or other data input apparatus) may be conneaed to the controller 14 and may be used to control and program the The components of the system, such as the controer 14, interface devices 28, data storage medium 20 and user interface device 30, may be incorporad as subsysteme within pump 12, or may exist as separate subsystem(s) extema to the pump 12 or may be integrated along with the pump s 42 in a common housing, consoe, cart, etc. Altmative embodimnts include al possible combinaton wherein one or more subsytem(s) isfare incorporate within the pump 12 or may be Integrted along with the pump 12 in a commn housing, console, rt, etc while one or more other subsystem(s) are exteml to the pump 12. For example, controller 14 and data storage medium 20 could be 10 inrporated into the pump 12 or may be inerated along with the pump 12 in a common housing console, ar, etc while user interface device 30 and interface devices 28 could be extema to the pump 12 or the housing, console, cart of otr boy or enclosure in which the pump located. It wil be appreciated that the pump 12 may be any suitable type of pump. 15 In some embodiments a peristaftic pump may be employed Such rosatic pump may comprise any suitable type of perstaltic pump, including but not limited to tradtonal paristaWic pumps, curviinear pedstaltic pumps such as those dedbed in United States Patent Not 6,371,732, e,84921 andfor 5 791 ,881, a linear peristallic pump as descdbed in Unte States Patent No. 5,24,852 or a 20 rotary xal p Iatafic pump such as th described in copending United States Patent Application Serdal No, 1212,931, the entire disclosures of such patents and patent ailion being ly incorporated here by rfrnce Basicay, a "rotary axial peristaltic pumps compnees a platen having a platen surface, a tube po&oned adjacent to the platen suface, a cam that rotates 25 about a rotational axis, such cam havIng a cam surface that is spacd apart frm the platen surface and a plurality of fingers, each figer having a longitudinal axis that is substantialy parallel to the rotational axis of the cam. The fingers engage the cam surface such that, as the cam rotates about the rotational axis, the fingers will move axlaly back and forth, sequentialy compressin the tube 9 against the platen surface, thereby causing peristaltic movement of fluid through the tube, The systm 10 may be In communication (via wired or wireless connection) with one or more extemal nrc devices 28, Controlir 14 may 5 be programmed to transfer afl or part of any database (eg all or part of the substance protocol database 22, subject protocol database 24, therapy-type protocol dtabas 2e, substance reference library database 40, system cnfiguration database 41 and/or histry database 43 to or fm extemal interface device(s) 28. For example, as illustrated in Figure 3, the user may 10 cate one or more substance pro ls 2M, subject protocols 204, or therapy typ Infusion protocols 36 on eeel interface devices 28 and subquently command the system 10, via the user interface dece 30, to copy, or download. the protocols to their respective databases on in the data storage medium 20. Likewise, the history file 43 may be copied, or uploaded, from the data storage is medium device 20 to extemal interface devils 28 as commanded by the user in one embodiment, after a nw substance protocol has been downloaded or created on the system 10 andifa stare reference rerd42 exiats in the substance reference library 40 for the substance incorrated in the new substance protocol, the poran operating in the controller 14 may check each 20 parameter of the now substance protc against paramer limits found in the substance reference rod 42 and against the sysm configurafon parameters 41. If any parmeter of the new substance proton violates the limits of the substance reference record 42 or the system configuration rameters 41, the conrMar 14 may then prvide an error signal and/or dis iow stoage of the new 25 substance protocoI to the substance protocol database 22 and prevent execution of te new substance protocol in some embodiments the proram operating in the controller may allow the violation to be overridden such that a new substance protocot wIth an out-of-limit parameter, may be stored and/or executed Permission to override a timit violation ray be control by proper a ruhozation 30 tcniques ( y g § by of a suparvisng physician's code or PIN). 10 In embodiments that incorporate a subject protoco! database 24, subject protocol records may contain subject Information 202 containing vadous information tha is specific to a human or animal subject, including for example the subjects name, address, age, bdy weight, gender, medical history, a list of 5 other medications received, aergies, reaction(s) to previous infusions, preferd vascular access site(s), prescrpions for substance to be infused, etc. Subject information 202 may be input into the subject protocol database 24 through the user ierace 30 or downloaded from another soure such as interface devices 28 (eg, penal computer 28a, USS lash drive device 28s' PDA 28b, barcode 10 reader 28c where a barde containing such information is read, or connect modem 28d, etc4 in one embodiment, a barcode label attached to the infusate vessel 16 contains information regarding the make up and/or substance of the infusata contained in the vessel 18, and/or information about the subject to recevs the 15 adminisaon of the infusate, and/or te definition of the infusion protocol for the administration of the infusate. By use of a barde mader 28c, the barcode label may be read and its Infomaton transfered to coter 14 where the program running on the cntler 14 may validate the barde iabei information against a substance reference record 42, if a corelating substance reference record exists 20 In t substance refrence library 40, and against the system confguration parameters 41. if the ifsion protc pirameters within berce abe I informatIon violate one or many parameter Amis found In an avaible substance reference recrd 42 or the system configuration parars 41, the controller 14 may prevent the barcode information from seig stOred or executed; hover, 25 such violation may be overridden with proper authorzation. Further, barcode subject data that Is inconslstent with any available subject informan 48 found in the subject proto database 24 may prohibit the storage or execution of the Infusion protoco; however, such prohibition may be overridden when propedy authorized. 1$ In embodiments of the system 10 that incorporate the optional subject query/responsa device 30 (also known as the user interface device) such queryesponse devIce 30 may be used to pose quedes to the subject at certain times (eg, spe ec times before, during or after a dose of the vision) and to 5 input to the controler 14 the subjects responses to those queries. For example, the subject query/rsponse device 30 may comprise a terminal that has a monitor or scre on which s pecic questions are displayed in written form and/or a speaker that poses audible queries to the subject in spoken form. Further, the input apparatus of the subject query/response device 30 may 10 comp e a touch screen, mouse, keypad, switch(s), joystick, encoder wheel, or other appartus by which the subject may input their response to presented quedes. The controler 14 may be in communcation with the query/response device 30 and programmed to present the queries to the subject at the desired points in time and to receive the subjects responses to the queries and to 15 evaluate and store the responses, As par of the evaluation process, the contoller 14 may be pogrammed to compare the subjects query responses to a reference library containing acceptable andor unacoeptabie responses. If the subjects response to a query is determined to be unacceptable, the controller 14 may be programmed to provide an alam or notice to the user and/or halt the 20 tnfsion and/or alter the infusion's execution (eg,, reduce the Infusion rate or stop the inusin) For example, during the administration of an Infusion of a Drug X, the controller may query the subject at different points In time as to whether the subjc is experiencing adverse reaction symptoms that are known to occur in some idividuals who receive Drg X (e go, the query might be: Are 25 currently expdrencing hives or itchy skin?, Are you currently ex perincing wheezing or shortne of breath?, Are you currently fencing blurred vislon?, etc4 The subjet then answers each query using the input apparatus of the subject query/response devce 30. The controller 14 then compares the subjects query responses to a reference database of acceptable and/or unacceptable 30 responses and determnes if the subjects query responses are indicative of an 12 adverse reaction. If the subjects query responses are determined to be indcatlve of an adverse reaction, the conler 14 may then effect remedial measure(s) in accordance with its programming. For example, If a subject's respnse indicates that he or she has begun to suffer a headache, the controller 5 14 may respond by changing the control signals to the pump 12 to reduce the infusion rate by a predetermined amount (e.g, 50%) and may then uery the subject at som later time, or at periodic time integral (e 5 minutes) to determine it the headache is cantinunt f the subjects query response Indicates that he or she is nong Ir experiencing the headache, the controller 14 10 may tn signal t pump 12 to continue the infusion in accordance with the originaly seated protocol or some reduced rate protoci in accordance with the controler's programmng. On the other hand, if upon requery the subject responds that he or she is continuing to experience the adhe, the controler 14 my ignal the pump to further reduce the rate of infusion or to halt the infusion 15 and/or at the operator In accordance with the manner the controller is programmed. Almatively or additionally in some embodiments, the system may incoporate sensors) 32 (e~g, vital sign monitors) for sensig certain bodily or phys igc vadables and communicating those sen variable (or indications of 20 changes in sense variables) to the ontler 14. The body or physiogic variales moniod by the sensor(s) 32 may Include bodily and/or physiologic variable that chang when a subject is expriencing an adverse reaction to an infusion (eiga, heart rate, blood pressure, body temperature, respiratory rate, oxygen saturation can monoxide aturation, galvanic skin response, away 25 resftion; etc) The controller 14 may be prrammed to issue special or modied control signals to the pump 12 (e&g, to slow the infusion rate or halt the infusion) and/or to issue an alarm signal to the operator in the event that the controler 14 receives a signal frm a sensor 32 indicative of an diverse reaction or other untoward ffc of the infusion, Also in embodiments of the system 10 30 that Incorporate the optional subject query/esponse device 30 as well as the 13 optional sensors) 32, the contoer 14 may be programmed to pose specific queries to the subject in order to confirm possible indications of adverse regions detected by the sensor(s) 32, Consider for example, hypothetical Drug Z, which when infused too rapidly is known to cause an adverse reaction 5 characterized by an incree in heart eate andnau In a sewhere Drug Z is being infused too rapidly for the subjW, the sensors) may communicate to the contrler the subjects heart rate in a continuous fashion, The contraler can then detect an Increase of heart rate ad cause the subject querresponse device 30 to ask the subject whether he or she is experencng nausea. If the 10 subject responds in he negative, the controller 14 may allow the pmp 12 to continue the infusion in acrdance with the original infusion protoi whie continuing to monitor for further changes in heart rate andor periodically querying the subject for the occurrence of nausea. On the other hand, if the subject responds that he or she is experiencing nausea, the controller 14 may 15 signal the pump 12 to modify the infusion protocol (eg., decrease the rate of Infusion and/or forego further increases in the rate of infusion) or to halt the infusion and/or to provide an alarm to the operator, in accordance with the manner in which the controller Is programmed In embodiments of the system 10 that in rate n infusion prool 20 database 26, such infusion protocol database 26 may contain pre-defind, non spec'ic infusion protocols or preset Infusion parameters which the user may select for use without regard to the subtnce to be infused or te subject to receive the infusion, When a non-specif infusion protcol has been selected from the infuelon protocol database 26, or programrnd via the user interface 25 device 30, the controller 14 may check the partners of the noncspeefle infusion protocol against the limits contained in the system configuration parameters 41 by the controller 14 to determine that ali parameters are within operating limits, If any paramtr of the non-spcift infusion potoI violates the system configuration parameters 41, the controller 14 may then provide an 14 error signal and disallow execution of the non-speclfic infuson protoof; however, such violation may be overridden with proper authorizations Further, in embodiments that include a substance reference lbrary 40, the operator may, by use of the user interface device 30, choose to associate the 5 non-specfc infusion protocol to a prtcuiar substance reference rod 42 found in the substance refernce library 40. Once the assoction has been made, the contrary 14 may chec the parameters of the non-spfic infusion protocol against the limits found In the substance reference record 42, Ift parameters of the non-spec infusIon protocol violate the parameters of the substance 10 raferene record 42, the cotroller 14 my then provide an rror signal and prevent exeution of the non-specffic irfusion protocol; however, such violation may be overidden with proper autrization. Further, pmper authorization, the operator may modify the nonspecific infusion protocol so that none of its parameters are in violation of the selected substance reference record 42 15 Lastly, in emodiments that include a subject protocol database 24, t operator may, by use of the user inteface device 30, choose to assodate the nonwspec infusion protocol to a particular subject protocol record 48 found In the subject protocol database 24. Once association has been made, the controller 14 may store the non4pecific infusion prtoal as a subject protocol 20 record 48 in the subject protoci database 24, in addition, If the non-specific infusion protocol had previously been assocated wt a substance reference record 42, t additional aslocion with a subset protoi record 48, thereby identng a subject, may cause the parameters of the non.sspeciic infusion protocol to be checked against t substance reference record 42 limits that are 25 subject specific. For example, where a nonspeniftc infusion protoco has been assodated with a substance reference record (eDg, Dg X which contains a lImitation that the total amount infused shall not exceed 10 rmg per 100 lbs of subject weight) and the non-specific infusIon protocol is later assodated with a subject protco record (e~g for Mr, Jones which includes information about Mr. 30 Jones' wght) then the controller 14 may determine if the substance refernce 15 record limitation for this specific subject is in violation given the non-specific infusion protocol parameter regarding total amount of subst be infued. Where t controer determines that a violation exists, the controller 14 may then provide an error signal and prevent execution of he non-scific infusion 5 protocol; however, such violation my be overden with proper authodzation. Further, with propr autrizaon, the operator may modify the non-specific infusion protocol so that none oftis parameters are in violation Set forth below Is a detailed example of an embodiment of the present invention, 10 Easf Smart immune Globulin (SIG) Infusion System and Method Referring to Figure 2, the SIG infusion system of this example includes a pump 10a, which pump includes a controller, motor and electrnics to operate the pump, user interface device (e.g., iquid crystal display and a touch screen 5 ovedald on the LCD), various operator keys, a sound producing audio subsystem, a microphone subsystem, a compact flash connector into which a IEEE 80211 (WiFi) wireless interface adaptor or Bluetooth adaptor can be mounted, a Universal Serial Bus (USB) host interface connector, a USB client inteace connector, a IEEE 802.3 ethemet conector, and a EIA RS-232 Serial 20 interface connector. The pump 1 a may include one or more senso(s) operating on the conduit 18 for detecting occlusions of the conduit 18 andfor air bubbles whin the conduit 18 as may occur when the infusate bag or vessel becomes empty, inadvertently disconnected or air leaks into the conduit 18 or vessel 16, The SiG infusion system of this example also incorrates soyeral interface 25 devices which communicate directly with the cortroler '14 These interface devices include: a personal computer 28a, a removable USS flash driver 23a2 a rsonal digital assistant 28b, a barode reader 2ft, a first telephony modem 28d and a second Wsfte ny modem 28e for providing connectivity to various 16 computer networs, personal computer, vital signs monitoring equipment, and other peripheral devices Personal computer 28a can be connected directly to the controller 14 through Interfaces of EIA RS232, USE cient IEEE 8023 Etmet, or IEEE 0211 b wireless interface, 5 Through these interfas the Intface devices (26a. 28a, 28b, 28c, 23d, and 289) may omunicat with the controller 14 for t purpose of sending and retrieving files or records tofrom the substance protocol databases 22, the subject protocol database 24, he infusion protocol database 28, and the substance reference ibry 40 (if stor separately from t sdbtancea protocol 10 databases 22). In addition, te personal computer 28a can monitor the activities of the SIG Infusion system 10a when connected, Atematvely or additionally, a personal digital assistant (PDA) 28b can be used to communicate with the SIG infusion system via a hard wired connecion such as EA RS232, US, and/or by a wireless interface such as an IEEE 802.11b wireless interface and perform 15 many of the same functins as the personal computer in nome embodiments of the invention, the persona computer 28a and the SIG infusion systern 10a may both be equipped with ports, such as USE pods, so tat a transfer device such as a USB flash ddive device 28a' can be used as a medium for the transfer of flies or data between the penal computer 28a and 20 the SIG infusion system 10a. For example, an infusion proto may be created on the personal computer 28a, then copd to the USE fash drive 28a and, thereafter, the US flash drive 28s' may be transported to and inserted In the correspondn USE port of the SIG infusion system I Da such that the files or data may be read direcdy by the controller 14 or transferred to ft controllefs 25 memory from the USE flash drive 28&' and stored In the infusion protocol database 26. An optional barde reader 28c (e1., DS660, Sym Technologies, Holtsville, New York or LG2, Opticon, inc, Orangeburg, New York) can interface to the SIG infusion system by means of EA RS232, USS, or IEEE 82.11b H7 wireless interfce for the purpose of redng and communing barcode information fmm barode symbols located, for example, on subjects In bracelet, drug reservoir, and/or ope Mr ID badge. Further, the barode reader 28c can be usd to program the SIG infusion system by fading a protocol, subject S information andor other data encoded on a barode symbol affixed to the bag or other vessel 16 containing an Immune Globulin preparation to be infused Fgure 2 also shows the connecting of various sensors (alo known as vital sign monitor) 32a, 32b, 32c to the contmilar 14 to monitor certaIn of the subject s vital signs. In particular, in this example, a first sensor 32a such as a 10 pulse oximater device (e.g., Radical, Masimo Cororation, ivne, California or OxiMax@ N-595, Nelicor, Pleasanton, Califomia) Isu to monitor pulse rate and oxygen satuion, a second sensor 32b such as a blood pressure monitor (eg. UA7467PO A&D Co, Lid., Saitama, Japan or HEM-71 AC, Omron Corporation; Kyot, Japan) is used to monitor blood pressure and a thIrd sensor 15 32c such as a boy temperature monitorng device (eg, Spot Vital Sins, Welch Allyn, Beaverot Orgon or Dataherm Grathem Medical AG, Geschwenda, Germany) is used to monitor the subjea body ternpeature. These sensors 32a, 32b, 32c are In communcation ith the ontrolar 14 by way of a wired or wireless connections, such as an SIA RS232, USB, or IEEE 802AI1b wireless 20 interface, Pulse rate and oxygen saturation sensor 32a provides an automated acquisition means of obtaining subject pulse rate and oxygen saturation level lood pressure sensor 32b prvides an auomated means of obtining the current diastoic and systoic blood pressure of the subject Temperature sensor 32c provides an automad means of obtaining the subject s tempetre. These 25 vital signs sensors 32a, 32b, 32c provide feedback to the SIG Inslon system 109 during t infusion pmcedure and the controller 14 is programmed to analyze such feedback for signs indicating that the subject is having (or is about to have) an adverse reaction to the infusion. If the SiG infusion system 10a determines that the subject is having an adverse reaction based on the 30 Informaion acquIred fmm the monitoring devices 32a, 32b, 32c, the SIG infusion is system I 0a can stop the infusion and notify tha operator of the subc condition, thereby averting potential injury to the subject Alternatively, the controller 14 may be programmed to make adjustments in the infusion protoco (e.g, decrease the rate of infusion or stop the infusion) in response to certain Monitored changes 5 in certain va signs that may be a prodrome or edy indication of an adverse reaction, thereby avoiding occurrence of a linicaly significant or full blown adverse reaction, Also, as shown in Figure 2, in some embodiments a first telephony audio modem 2ed may W connected to the infusion system 10a and a second 10 telephony modem 289 connected to a remote monitoring and control system 29 such as a personal computer. Modems 28d, 28e, connected together by wired or wireless tephony, may provide pear-to-per connectivity means thus allowing a remote monitoring and control system 29 to Interact with te SIG infson system 10a directy; A remote nitoring and contml system 29 may also communicate 15 with the SG Infusion system I a in a peer-to-peer connection via I EE 802.1 or Bluatooth wireless interface Lastly, the remote monitoring and control system 29 can be connected to a inohouse network which includes IEEE 802.11 wireless aess points devices through which the SIG infusion system, via IEEE 802.1 wireless Interface, can communicate with the remote monitoring and control 20 system 29, such as In a hospital environment Databses and Records Figure 3 illustrates an embodimnt of a set of databases, folders, files, and/or records that are created, maintained, and accessed in the process of programming, selecting, and executing protocols for use by the SIG infusion 25 system 10aI. In this example, non-specific infusion protocols (comprising infusion protocol, infusion frequency, etc?), substance protocols (comprising substance name, manufacturer (if specfe), diluentisolvent to be use, substance concentration in infusate, specific Instructions of infusate preparatrconstitutioddilution, e) and subject protocols (comprising 19 specificatons for subjects age, weight, date of birth, infusion protocol, etc) are created by the operator using the SIG infusion systern 10a or rmo tely on a personal computer 28a using an Infusion Configuration Prgram (iCP). Protocols created using an lCP may subsequenly be transfrd to t 5 appmpdate databases of the SIG infusion system 10a. A substance protocol may include information (eg, substance name and concentration) relating to a speciftic therapeutic agnt and op t ionally a link to a substance reference record 42 in a substance reference library 40 for the purpose of confirn~hg that the substa protocol Is within allowable parameters, 10 INFUSION PROTOCOL DATABASE In the example shown in Figure 3, the infusion protocol database 26 prvides storage for infusion protocols (eg. non specf infusion protocols and other infomaton included in a parclar infusion protocol , In this embomdrent, infusion protoIs may be categorized or organized in three therapy categodes: 15 IG, SQIG and CONT. The CONT therapy categry is a continuous infusion mode wherein a continuous infusion is administerd by a desired route of adminIstration (eg., Intravenous, subanous, epidural, etc-) Each therapy category can have any number of infusion protocls in it. in one embodiment, the therapy grouping is accomplished by use of file folders 34 maintained on a 20 computer 28a h a flash disk drive or other suitable storage device. On the flash disk ddve three file folders 34 are created, one for each therapy t. Non specific infuson protcs are cIrated and stord in e folders 34 according to therpy type SUBSTANCE PROTOCOL DATABASE 25 The substance protocol database 22 stores substance protis that are intended to be used when infusing particular substances as described generally hereabove. In this example, the substance database 23 is divided into three flies or categories, namely IVIG, SQIG and CONT, in a manner simiar to the infusion 20 database. Each therapy category can have any number substance protocols for a verity of substance's (e.g., various different Immune Globuin preparations), In one embodiment the therapy grouping Is accompished by use of file folders 38 maintained on a computer system with a flash disk drive or other suitable storage 5 device. On the flsh disk drive three file folders 38 a re acted, one for each therapy type. As substance protocols are created or downloaded, ty are stored in the flash disk drive folder according to their therapy type Substance protocols stored in the substance protocol database 22 define infusion parameters and the substance to be infused, The substance to be 10 infusd may or may not exist as a substance reference record 42 In the substance reference library 46. If a substan e ce record 42 for the particular substance Is found in the substance reference library 46 (Identified by substance name, concentration, and requl administtion route) thn the parameters of the substance protocol are compared to corresponding program 15 infusion limits found in the substance reference record 42. If a specific substance reference rd 42 is not found in the substance reference l brary 46, the operator may then input Oh substance name, concentration, and required administration route and however, no comparison of the inputted parameters of the substance prtocl to program infusion limis from a substa reference 20 record 42 wIli bemade nor will adverse reaction monitoring be perform, In this example, no subject data is included In the substance protocols stored in the substance protocol datbase 22. it wilN be appreciated that adverse reaction feebac mounting my be used even when no substance reference record 42 is in use. For example, the 25 system may be programmed with absolute limits for monitored parerneters (e g., heart rate, body temperature, etcj and when one or more of those absolute limits are exceeded, t controller 14 may undertake remedial measures such as a decrease of infusion rate or stop the infusion 21 SUBJECT PROTOCOL DATABASE In this example, the subject protocol database 24 is used for storage of subject data and subjc protocols for individual subjects to eeive Immune Globulin infusions (either IVIG or SWlG) from this SIG ystem 10as In many 5 applications,such as in-hospital and home infusion applications, a single SIG insion system 10a may be use to treat a number of different subjects and the subjt protocol database 24 allows the SIG system I Ga to store and rcall information on each of those subjects subjectspecii infusion prtocos or other subject information may be organized and stred In sepa t folders 48 for 19 each subjectTh controller may be prgrammd to allow each subj folder 48 to contain only one not of subject Information and no more than one of each type of terpetpoocol (eg. VIG therapy protocol. SMGG therapy protocol, and CONT therapy protocol) Aftematively, the controller may be pogrammed to allow each subject folder 48 to contain one set of subject Information and multiple 15 therapeutic protons of each therapeutic type. SUBSTANCE REFERENCE LIBRARY The Substance Reference Library 46 provides storage for one or more subsntace reference records 42 or other substance information in one embodiment each substance reference record 42 may Identify by substance 20 name, substance concentration, and required administration route, A substance reference record 42 may also contain proan insion limits that the controller 14 wil use to determine if the subsancv protocol to be executed is safely within the sbstance reference rord limits. The subsance reference record 42 may include various absolute infusion limits (e.g abslute maximum infusion rate, 25 absolute maximum volume to be irfused, absolute maximum duration, and absolute minimum duration.) In addition, the substance reference record 42 may include variable infusion limits depndent on subject's weight, age and/or gender. Thertor when a subjects weight, age, and gender are known, a particular set of program infusion limits, more conservative than the absolute lmits, may be 22 retrieved from the substance reference record 42 for comparison to the infusion protocol parameters The substance reference record 42 also may contain a recommended total dose amount per a cours of treatment based on a particular disease the 5 subject may be suffering, When multiple protocols for the same substance are administered to the same subject, t SIG infusion system 10a may keep a running total of the amount of the particular subsce the subject has received. If the running total of th amount of substance exceeds the specified toa dose amount per course of treatment, ten the SIG infusion system 10a may issue an 10 alarm stopping the sion and ale the operator The substance referee rerd 42 may also include an adverse reaction symptom list 46 which conins a prdetermined list of symptoms, the criteria for w the symptom is to be considered an adverse reaction, a classIfication of the adverse reaction, and additional text information to be presented to the 15 operator via the usrnterfa device 30 in the event that the adverse reaction is detected. An optional pre-infusion checklist can be added to a subalance reference record 42 and the controller 14 may be programmed to cause that pre-infusion checklist to be displayed to the operator before an Infusion is begun The pre 20 Infusion checklist may contain t t instruction for the operator of the SIG infusion system 10a who is about to begin an infusion, Such instructions can remind t operator; for example, to make various vital signs checks of the subject prior to running the infusion anor to be sure the subject had ben pr medicated. 25 Figure 3 illustrates an embodiment that includes a substance reference library configurator program 44 that Is operable on a personal computer 28a and useable to create and maintain the substance reference library 40. A substance reference library 40 may be created, and substance reference records 42 may be 23 added, modified or deleted, using the substance rerence library configurator program 44. in order to control access and integrity of the substance reference brary, the substance reference library confuralor program 44 cannot be operated on he SIG inusion system I0a itself. 5 The adve reaction symptom selection lst 46 is a list of physiologic symptoms that a subject may suffer during an infusion, In one embodiment, this list 46 is a list of various symptoms a subject may afer dudlng an infusion of MG. Such symptoms may include high or low blood pressure, high or low body temperature, iow oxygen saturation level, high or low pulse rate, headache, 10 shortness of brath, nausea, vomiting, lightheadednes and others. This list 48 may be merely representative and not exhaustive. The adverse reaction symptom selecton list 46 is accessible by the substance reference flbrary configurator program 44 for use by the operator n creation of a substance reference record 42, 15 The substance reference library 40 should be created and maintained by an authorized party of the institution responsible for the infusion. In as much as the substance reference library 40 may be critical to the safe Infusion of MG and other substancs, s rudty of the substance reference library 40 may be important In one embodiment, secudty of the substance reference library 40 20 may be accomplished by providing substance reference library configurator program 44 that properly interprets and modifies the contents of a substance reference library 40, Further, the subsanc rference library 40 Itself may include one or several cyclc redundancy check (CRC) parameters which allows the substance reference library configurator program 44 to determine if the 25 contents of the substance reference library 40 had been changed since the CRC parameters were last calcuated and stored. In addition, pharmacists or administration personnel may be required to log into the substance reference library configurator program 44 by providing their usemrname and password in order to opert the program, The authorize party may thereby create or 30 modify subance reference rds 42 by defining absolute infusion limits, one 24 or more sets of program infusion limits based on weight age, and gender of potential subjects, and maximum substance amount to be infused for a course of treatment based on the disease the subject may be suffering. The modified or newly created substa reference records 42 will then be applied to all 5 substance infusion protocols 200 that reference the substance referencerco 42. Sources of Infmomation needed to create or modfy a substance reference record 42 are the substance manufacturers or as otherwise known in the medical infusion community. In addition, the authorized party creating or modifying a substance 10 refeece record 42 may select appropriate symptoms from The adverse reaction sympm selection list 46 that relate to the infusion of the specific type of NIG substance For each selected adverse reaction symptom, criter for claa ifying the adverse reaction as mild, mode or severe is provided by the authorized party. For adverse reaction symptoms, mild, moderate, and severe, t 15 authorized party may also define a message to be displayed to the operator on the occurrence of the mild, moderate or severe adve reaction symptom. Soue for criteria constituting an adverse reaction are the substance manufacturer or as otherwise known in the medical nfusion community. After all substance reference records 42 have been entered into the 20 substance reference library 40, the substance reference library 40 Is saved to the personal computer 28a hard drive, or alternatively to a network server If the personal computer 28a is connected to a network By use of the substance reference library confg program 44, the authorized party may also perform maintenance functions on the substance reference library 40 such as renaming, 25 erasing, copying, printing, or deleting substance reference records 42 A modified substance reference record 42 can be saved as a new substance reference record 42 or overwrite the original source substance r rence record 42. 25 In order for a V1G infusion system I0a to use the substance reference library 40, the substance reference library 40 must be transferred to the SIG Infusion system 10a by a communIcatIon means such as a wired or wireless interface device 28. Various wired interfaces are contemplated in this invention 5 for communIcationbe en a peonal computer 28a or netrk s and the SIG infusion system I0O such as EIA RS232 serial ltedace, IEEE 802,3 Ethemet and Universal System Bus (USE Atemativey, wireless communication means such as IEEE 8021 WFi or Biuetooth technolois can be applied for t transfer of the substance reference library 40 to the 8VG 10 infusion systm Further, transfer of a substance reerens library 40 from the computer 28a on wh it has been prepared to the controller 14 of the SIG Infislon system 10a, may be accomplished by use of data medium dev* such as a USS flesh drive 2&t. In suh instances, the substance reference library 40 will be copied to a folder on the USS Flash Drive 2a. Then the USS Flash 15 Drive 28a Is removed from the personal computer 28a or netwo* system and inserted into a US port of the SG infusion system 10a and, after satisfyi security access requirements, the substance reference library 40 Is saved Into the memory of the contrler 14 Conversely, when it is desired to update or modify a substance reference library 40 (or any of the databases 22, 24, 28 20 stored in the controller 14 memory) such substance reference ibrary 40 maybe uploaded from the controller 14 to the USE lash Drive 28' and then transferred to the computer 28a where the desired updating or changes my be made, Menus 25 HOME MENU In this example, all operator interaction with the SIG infusion system 10 begins at the "HOME" menu as shown in Figure 7. When the SIG Infusion system 10a is first turned on, the home menu is displayed on the LCD display, In 26 addition, when no infuslan is in progress, the SIC infusion system 10a menus will permit the operator to select to go to the home menu. The HOME menu provides a varying list of selectins based on the particular state of the SIG infusion systern. The possible selections are: 5 CONTINUE Rx, REPEAT Rx, SELECT Rx, and PROGRAM NEW Rx. CONTINUE Rx The CONTINUE Rx se lIon is available if an infusion was stopped before it was fini If the operator chooses CONTINUE Rx, the operator is presented the standby menu, shown in Figure . 10 REPEAT Rx The REPEAT Rx selection is available if an infusion that had been in press was either stopped or completed, if an infusion that was in pogress was stopped before completion and an attempt to repeat the infusion protocol is made, then the controller 14 of the SIG infusion system 10a will alert the operator 15 that proceeding wlil result in cancelation of the previously Interrupted infusion, If no infusion had been in progress or if the operator acknowledges canceling of the infusion that was in press, the Rx SUMMARY form shown in Figure 9 will appear, If the operator accepts the Rx SUMMARY form, the SIG infusion system IOa wil display the STANDBY menu, shown in Figure 8, from which the operator 20 can then run the infusion. STANDBY MENU The STANDBY menu is displayed when programming is complete, or acepting an Rx SUMMARY form, or when the CONINUE Rx button is pressed on the HOME menu, and when clearing an Alarm. From the STANDBY menu, 25 the operator can: a) run t infusion, b) prime the conduit, C) review/modify the infusion or d) set a delay start time for the infusion. 27 SELECT Rx The SELECT Rx selection is available if there is at least one infusion protocol selectable from the database(s) 22 and/or 24 and/or 26 stord in the memory of the controller 14. If the infusion in progress had been stopped and an 5 attempt to select another infusion protocol Is made, then the SIG infusion system alerts the operator that proeeding wilt cancel the Rx that had been stopped. If no infusion had been in progress or the operator acknowledges canceling of the Rx in pogrss, a SELECT R menu, shown In Figure 10, is displayed alowing selection of a subject protocol from the subject protocol database, substance 10 protocol form the substance protool database, or an Infusion p Iocol frm the Infusion proocol database PROGRAM NEW Rx The PROGRAM NEW Rx is always an available selection on the HOME menu, If the infusion in progress had been stopped and an attempt to program 15 new Rx is made, then the SIG infusion system alerts the operator that proceeding will cancel the Rx that had ben stopped. If no Rx had been In progress or the operator acknowledges canceling of the Rx in progress, she will have the opportunity to create a now Rx as described later in this disclosure. INITIATE Rx 20 In the event the SIG infusion system was programmed with an Rx or an Rx selected from an Rx database and the SVG infusion s myste was turned off, the subsequent tum on of the SIG infusion system will present the operator with the HOME menu; however, the INITIATE Rx selection will appear in place of the REPEAT Rx selection. When the operator sets the INITIATE Rx, the Rx 25 SUMMARY fom wil be displayed. If the operator accepts the Rx SUMMARY form, the SIG infusion system 10a will display the STANDBY menu, shown in Figure 8, from which the operator can hen run the infusion. 28 SATISFY SECURITY REQUIREMENTS When the operAtor selects REPEAT Rx, SELECT Rx, or INITIATE Rx; she may be required to enter an access code on t SIG infusion system via touch screen entry to satisfy security access. Alternatively, the operator might be 5 required to identify herself to the SIG infusion system program by use of a barcode reader, attached to the SIG infusion system, which is used to read the operatofes bade information from her badge. Rx SUMMARY Referring to Figure 9, the Rx SUMMARY form provides a summary of the 10 infusion parameters which the operator may acpt, modify, or cancel. if the operator elect to modify the infusion parameters, the operator is than presented with the infusion programming screen (of the therapuic type) and makes the desired modifications. After making modifications the operator accepts the modticanon and the infusion is checked against substance reference recod 42 15 infusion limits if the Rx includes a reference to an existing substance reference rerd 42 The operator can then save the modid infusion as a new infusion protocol, if appklcable, or overri the original infusion protc I Creating a New Infusion Protcl 20 SATISFY SECURITY REQUIREMENTS Figure 4 illustrates a method of creating an infusion protoco. The StG infusion system 10a allows programming an infusion protocol after the operator has satisfied the security requirements 50 of the SiG infusion system 10. In one embodiment, the operator may be required to enter an access code on the SIG 25 infusion system 10 via touch screen, Alternatively, the operate might be required to identify herself to the SIG infusion syste I0a by use of a barode 29 reader28c to ad the operator's barcode information from a badge, identification card or the &ke. After the operator has satfisfed the SIG Infusion system's security requirements, the SIG infusion system 10a program displays a solet therapy 5 menu 51 from which the operator selects the therapy type. IVIG, 801G, or CONT. The operator then makes a selection of one of the therapy types and proceeds to program the infusion paramters. MG INFUSION PARAMETERS In t case of MG therapy type, the operator inputs IG infusion 10 parameters 52 for: volume to be infused, minimum infusion ime, maximum infusion time, maximum rate of ifuslon, base (initial) rate of infusion, rate increment, and step duration, In the present invention, the infusAion profile is calculated from the infusion parameters prior to starting the infusion. One example of such MG infusion 15 profile is shown graphically in Figure I. The infusion profile may consist of one or several steps wherein each step includes up to wo segments. The first segment provides an appmximate constant change of rate or ramping segment (eig, 12 millliters/hourlsecond) from the termna rate of the previous step (or zero in the case of being the firt step to be executed) to the teminal rate of the 20 ourrnt step. This ls represented on Figure 11 by the initial up-sloped lne at the beginning of each of Steps 1, 2, 3 and 4. Once the terminal rae has been achieved in any step, that stp contnues at the terminal rate until the volume to be Infused for that step has been delivered, or until the step duration has elapsed This is represnted in Figure I1 by the flat line that follows the initial up 25 sloped line in each of Steps 1, 2, 3 and 4. Where the change of rate is suffiently high (eg 12 milllliters/hour/second, the minimum step duration suffi ently long (e g, 300 seconds) and the maximum rate of infusion is sufficiently limited (eg 1000 miitersihour), each step will reach Its terminal 30 rate before the step has terminated (except potentially the last step duing which it Is possible that all the volume to be infused for the entire infusion has been delivered before the terminal rate of the last step has been reached.) For example, where a single step is to start from an initial rate of 0 milliterhour and 5 reach a maximum rate of 1000 mililiitershour and the constant change of rate is approximately 12 mlliliterhorl (thereby maximizing the duration of ramping), the step will finish its first or ramping segment In 83.3 seconds which is much less than the minimum step duration of 600 seconds; therefore, a terminal rate segment must follow the ramping segment. 10 The series of infusion profiles steps are computed by calculating the first step and tn subsequent steps. The ramp segment of th fist step starts at a zero mliiters per hour rate and Increases, at an almost constant rate, until the rate reaches the base (Initia) rate. The calculated volume delivered by the first step is calculate as the sum of the volume during the ramping segment and the 5 terminal rate segment. The remaining volume is then calculated as the total volume to be infused minus the volume of the first step. The number of possible remaining steps can next be calculated by dMdi the dfference of the maximum rate of Infusion and t base (initial) rate of infusion by the rate increment, rounding the quotient up, and adding one to the quotient The 20 computaions for each of the subsequent Infusion steps is generly calculated by starting the ramp segment at the terminal rate achieved by the prior step and Increasing the rate, by a constant chang of rate, until one full rate increment has been added to the terminal rate of the prior step; thereafter following with a terminal rate segment maintaining the rate achieved at the end of the ramp 25 segment The calculated voume delivered for each step is subtracted from the remaining volume and if the remaining vure Is reduced to zer or less, the step being calculate is considered the last step having a reduced volume and execution time sufficient only to deliver the last of the remaining volume If at any time the calculated ate of a step would exceed t maximum rate, the rate of 30 that step Is limited to the maximum rate. In addition, as the steps are calculate, 31 their execution time is summed up A if their total execution time becomes equal to, or greater than, the maximum infusion time, that step under calculalon will be the last step and will terminate so that the infusion time will not exceed the maximurn infusion time, In the case where the rate of the hlat step (eg, Step 4 5 In Figure 11) has been im by the maxmum rate of Infusion, the calculaion for that step's duration will be extend until all of the volume to be infused has been delivered or until the maximum Infusion time has been reached. SQIG INFUSION PARAMETERS In the case of SQIG therapy type, the operator Inputs SQIG infusion 10 parameters 53 for (or their value is calculated): volume to be infused, rate of infusion, and time of infusion. Time of infusion is caloulat when volume to be infused and rate of infusion are entered. CONT INFUSION PARAMETERS In the case of a continuous infusion therapy, the operator inputs 15 continuous infusion parameters 54 for (or their value Is calculated): the units of measurement to be used (e.g. milliliters (ml), milligrams (mg), or micrograms (mcg)), the concentration of substance in the infusate (if weight units such as milligrams or micrograms had been selected), total volume of Infusate (e.g., 'bag volume"), the volume or amount of infusate to be Infused, up ramp time, infusion 20 rate (after up ramp completed), total infusion tie, and the keep vein open (KVO) infusion rate. TPN INFUSION PARAMETERS In the case of a total parental nutrion (TPN) infusion therapy, the operator inputs parameters for (or their value is calculated): the volume to be infused, up 25 ramp time, Infusion rate (after up ramp completed), down ramp time, total Infusion time, and the iep vein open (KV0) infusion rate. Total infusion time is 32 calculated when volume to be infused, rate of infusion, up ramp tme, and down ramp time are entered. SELECTING A SUBSTANCE REFERENCE RECORD 42 TO BE USED WITH THE INFUSION PROTOCOL 5 The operator may choose to associate 55 the infusion protocol with an existing substance reference record 42, create a new substance specification 56 by defining substance name, concentration, and administration route, or not associate the Rx with any substance information. Ifthe operator creates a now substance specfication, t new specification will not be added to the substnce 10 reference library 40 and will be used as textual information only by this infusion. ASSOCIATING SUBJECT DATA WITH THE NON-SPECIFIC INFUSION PROTOCOL The operator may choose to associate 57 previously defend subject information from the subject protocol database 24 or to input new subject 15 Information to be associated with a new subject. Subject information may include subjecs name, date of birth, weight, and gender. CHECK PROGRAMMED INFUSION PARAMETERS AGAINST LIMITS After programming all infusion parameters and choosing whether to associate the Rx with an existing substance reference record 42 and subject 20 data, the SIG infusion system wl check the programmed infusion parameters against predefined absolute limits 80 found in the substance erence record 42 and, if subject Information is provided, further check against more conservative limits specific to subject information 62. For example where the weight of the subject is known and substance reference record contains limits that are weight 25 specific, the subject's weight may be used to determine if a more spific limit should be applied to the infusion parameters. Age can also be used as a subject 33 speefic characteristic that can activate more conservative limits If the drug reference record contains such Uimit definitions. The SIG infusion system may also check the expected volume to be delivered during the Infusion will not violate the maximum dose amount per 5 course of treatment, If the addition of the expected volume to be delivered wig exceed maximum dose amount per course of treatment 63, the operator, after satisfying access code requirements, is given the opportunity to overide 64 the limit check violation, If the operatr overrides the Imnit check violin, the override event is dogged to the history file 66 and the infon ia save to a 10 database 67. If the operator does not ovefrie the limit check violation 65, the programmed infusion parameer In violatn must be modified to be within lim or the controller will prevent the fusion from being started If the infuson is not associated with a substance reference record 42. then no checking for substance reference record 42 related limits is performed and the 15 infusion protocol is saved 67 into the appropriate database 22, 24, 26. SAVE CREATED Rx TO A DATABASE After programming all infusion parameters and checking the parameters against lImits found in the associated substance reference record 42, the infusion is saved to the appropriate database 22, 24, 26. In one embodiment, if the 20 infusion protocol does not include any substance specificain or subject specification, it is saved 67 to the infusion protocol database 26 under the therapy specific folder 34 (IG, SG, or CONT). If the infusion protocol does not contain subject information but does contain a substance specification, whether or not that substance apcificatIon is found in the substance reference 25 library 40, the infusion is saved 67 to the substance protc database 22 under the therapy specific folder 38 (MG, SGI, or CONT) If the infusion protocol contains subject Information then that infusion protocol, including the subject 34 information, is saved 67 to the subject protocol database 24 in that subjects folder 48. INFUSION CONFIGURATION PERSONAL COMPUTER PROGRAM The infusion Configuration Prgram (QCP) is a prgram, operable on a 5 personal computer 28a that simulates programming of infusion prooics directly on the SIG infusion system 10a. The lCP creates subject ptocols, substance protocls or non-speific infusion pmtocols which can be transferred to the appropriate database 22, 24, 26 of the SIG infusion system 10a via any of the above mentioned connectivity mediums 28a-28e. 10 sasflng an Existainfusion Protocol from a se Figure 5 illustrates th sel ctio of an infusion protocol from the subject, substance, and infusion databases 22, 24, 26. SELECTING A SUBJECT-SPECIFIC INFUSION PROTOCOL In order to select an existing subject infusion protocol from a subject 15 protocol database 24 for infusion, the operator must satisfy the SIG infusion system's security requirements 70. In one embodiment, the operator may need to enter an access code on the SIG infusion system via touch screen entry to satisfy security access Altematively, the operator might be quired to identify herself to the SIG infusion system pgram by use of a barcode rader 28c to 20 read the operators barcode information from a badge, identification card or the like In one amo diment, the operator is presented with a selection list 71 whereby the operator may select the substance protocol database 22, subject protocol database 24 or infusion prooi database 26, If the operator selects the 25 subject database, Ahe is presented wth a list of subjects (egG, subjects or clinical study participants) from which the operator must select 72 After the operator 35 selects a particular subject 72, if there is more than one subject specific infusion protocol available for that subject 75, a list of avaiable infusion prtocols will be displayed for selection 76, Folowing the selection of the desired infusion protocol for that subject, the operator is presented with a summary of the infusion 5 protocol 83 which the operator may elect to accept, modify, or cancel If the operator chooses to modify the selected infusion protocol, she is presented with the infusion programming screen and may make desired modifications 85. After making modifications, the operator accepts the modification and the subject-specific infusion protocol is checked against iuson 10 limits for that substae that may be contained In the substane reference library 40, If there Is a substance reference recor 42 for that substance and the infusion parameters do not violate the limits set in that subsance reference record 42, the operator can then save the modWd subjctspecific infusion protocol by overwriting the original 87. Alternatively, the otperato may elect to 15 save the modified subject-specfic infusion protocol saved under a new subject name without modfyng the original source protocol in the database, SELECTING A SUBSTANCE iNFUSION PROTOCOL In order to select an existing substance infusion protocol from the substance protocol database 22 for infusion, the operator must satisfy the SIG 20 Infusion systerrs securty requirements 70, In one embodiment, in order to select an existing substancepecific infusion protocol, the operator may need to enter an access code on the SIG infusion system via touch screen entry to satisfy security access Atemrnativey, the operator might be required to identify herself to the SIG infusion system program by use of a barcode reader 28c which 25 is used to read ta operators barcode fromthe operators badge, identification card or t;he like. In one embodiment the operator is present with a section list containing selectable databases 71 such as the substance protocol database, '36 subject pro database and therapy-type protocol database. if the operator selects the substance protocol database, she is presented with a est of therapeutic types 73: MG, SMIG, or CONT, If the operator selcts IG, she is presented a ist of NIG substance prtoco records from the substance prtocol 5 database 77. If the operator selects SQG. she Is presented a list of SQIG substance protocols from the substance protocol database 78. If the operator selects CONT, she Is presented a list of CONT substance protocols from the substance protoco database 78 After selecting a substance-speciflc infusion protocol, the operator is presented with a summary of the substance-specific 10 infusion protocol parametrs 83 to which the operatr may accept, modify, or cancel. If the operator chooses to modify the selected protocol 84, she is presented with the infusion prgramming screen and may make desird modifiations 85. After making modifications, the operator accepts the 15 medication and, if the substance-spific infusion protocol includes a reference to an existing subsance reference cord 42, the infusion is checked a inst substance reference record 42 infusion limits85. The operefor can then save the modified infusion as a naw substance protocol 89 or overwrite the original 87. If the operator accepts the originally selected substance protocol or 20 accepts and saves a modified substance protocol, the substance protocol is loaded into the SIG infusion system for infusion. SELECTING AN INFUSION PROTOCOL BASED ON THERAPY TYPE In sore embodiments, the system includes a therapy-tye infusion protocol database 2.In order to select an existing therapy-type infusion 25 protocol from the therapytype Infusion protocol database 26, the operator must satisfy the SIG infusion system's security requirements 70, In one embodiment, in order to select an existing protocol from the therapy4ype infusion protocol database, e operator may need to enter an access code on the SiG infusion 37 system via touch screen entry to satisfy security access. Alternatively, the operator right be required to identify heref to the SIG infusion system program by using a barcode reader 28c to read a barcode on the operator's badge, idetificaton card or the W. 5 After gaining access to the system, the operator is presented with a selection list of som or an of the available databases For example, the operator ay view a screen that alows the operator to select either the substnce protocol database 22, subject protocol database 24 or therapy-type protocol database, if the operator selects the therapy-type protocol database 26, she is 10 thn presented with a list of therapeutic s 74, such as: IVIG, SQIG, or CONT If the operator seects MG, she is then presented a lst of one or more MG infusion protoc$(0) which are suitable for, or have been historically used for, IVIG therapy but which are not specific to any particular subtnce or any particular subject. If the operator selects SQG, she is then presented a Wit of one Ore i5 more S=0G infusion protocol(s) which are sutable for, or have been historically used for, SQIG therapy but which are not specific to any particular substance or any particular subject if the oprator selects CONT, she is presented a list of one or more CONT infusion protocols which are suitable for, or have been historically used for, CONT therapy but which are not spec i to any particular 20 substance or any particular subject. After seeing a therapy-type infusion protocol, the controfer may then prent the operator with a summary of the infusion parameters 83, some or all of which may then be accepted, modified or cancelled by the opator If the operator chooses t modify the selected infusion protocol 84, she is 25 presented with t infusion programming touch screen presentation that may be used by the operator to make the desired modifications 85. After making modifications, th operator can then save the modified infusion protoo as a new therapy4ype infusion protocol 89 or overwrite the original therapy-y infusion protocl that had been moded 38 If the operator accepts the originally selected therapy-type infusion protocol, or if the operator accepts and saves a modified trapy-type infusion protocol, the controller will then load the selected protocol into the SIG infusion system 1Oa for infusion 5 STANDBY MENU After a particular infumIon protcci has been accepted by the operator for infusion or If the operator stops an infusion that is in progress, the operator is presented with a *standby menu (Figure 8) alowing her to *run", "prime" and "review/modity Rx% in the even that t operator stopped an infusion In 10 progress, a "sta" selection is provided to allow review of the progress of the now stopped infusion. RUN Selecting run displays a confirmation run menu asking if it is proper to start the Infusion. Selecting yes to the confirmation menu wi cause the infusion 15 to begin running. The SIG infusion system then starts pumping and administers the substance according to the loaded Rx infusion parameters. PRIME The prime feature allows the operator to prime te administration set with fluid, replacing any air that may be in the administration set. Selecting prime 20 displays a prime advisory rneau instructing the operr to dicnnect the SIG infusion system from the subject. After the operator responds to the prime advisory menu, the prime screen is displayed instructing the operator to press and hold the prime button to prime the administration set. Pressing and holding the prime buton will cause up to three millilIters, for example, of fluid to prirm the 25 administration set If the prime buton is released or three milfIters of prIng has occurred, the priming will stop. Releasing and then presing the pime 39 button again will cause the prime to resume and allow up to another three millifiters to be pumped. REVEWIMO7IIFY Rx The review/modify Rx feature allows the operator to review the infusion 5 parameters for te Rx that is loaded. in addition, if subject information and/or substance data is associated with the loaded Rx, then that data may also be reviewed. If the operator desires, the Rx under review may be modified if the operator can satisfy the SIG infusion system securty requirements, MG INFUSION PROFILE 10 When infusing an IG therapy, the MG rate profile starts at the base rate and then increases by the rate increment when the step duration has elapsed, This process ofincreasing the rate by the rate increment continues at the elapse of the step duration until the maximum rate is achieved or the volume to be infused has been delivered, If in the last step a full rate increment increase 15 would exceed the maximum rate, the final rate is the maximum rate only. The transition from one rate to another is attained by a controlled ramp to ease the physiological effects of the sudden increase of substance delivery to the subject. Once an infusion reaches the maximum rate, the infusion continues at the maximum rate until the volume to be infused has been delivered, 20 SQIG INFUSION PROFILE When infusing a SQ0 therapy, the SQIG rate of infusion ramps up to the programmed rate of infusion in a controlled manner, Once an infusion reaches the programmed rate, the infusion continues at that rate until the volume to be infused has been delivered. 25 40 CONT INFUSION PROFILE When infusing a CONT therapy, the CONT rate of infusion ramps up to the programmed rate of infusion according to a programmed up ramp time parameter. Once the up ramp time has elapsed and the rate of infusion reaches 5 the programmed rate, the infusion continues at that rate until the remaining volume to be infused has been delivered, After finishing the delivery of all the volume to be infused, the SiG infusion system will run at the programmed KVO rate. REALTIME DISPLAY OF INFUSION PROGRESS 10 When t infusion begins running, the infusion status screen is displayed showing: volume infused, remaining volume to be infused, current rate, target rate, infusion time, and remaining time. For IVIG therapy, current step is included on the infusion statue screen. trac tion by Operator with an Infusing Rx 15 While an infusion is running, the operator may interact with the infusion by stopping (pausing) or titrating the infusion. STOPPING AN INFUSION Anytime that an infusion is running, the operator my stop the infusion by pressing a stop button. So doing will cause the infusion to stop and display the 20 standby menu, providing selections of run, prime,. review/modify Rx and status. TITRATING While the SG infusion system is running an infusion, the operator can choose to titrate or change the infusion rate by pressing a button on the infusion status menu. Changing the infusion rate may require the operator to enter an 25 access code on the SIG infusion system via touch screen entry to satisfy security 41 access. Alternatively, the operator might be required to identify herself to the SIG infusion system program by use of a barcode reader, attached to the SIG infusion system, which is used to ead the operator's barcode information from her badge. 5 If the therapy ye is MG and therefore has a stepping profile, a screen is displayed giving the operator the choice of keeping the current stepping proffie or finishing the remainder of the infusion at the now infusion rate. Retaining the stepping profile may cause the number of steps in the remainder of the infusion to be recalculated. 10 Adverse Reaction Monitoring Adverse reaction monitoring (ARM) monitors the subjects vital signs and subjects symptom responses to help the operator determine if the subject is having an adverse reaction to the infusion. in order to use ARM, the SIG infusion 15 system must be loaded with a substance protocol for which a substance reference record 42 exists in the substance reference library 40, Prior to using ARM for vital signs, subjears vital signs data must be taken to establish a baseline reference for subsequent reading of vital signs. VITAL SIGNS 20 Vital signs monitoring is the periodic acquisition of physiological vital signs data from a subject. Vital signs to be monitored and the frequency of monitoring are determined by the institution responsible for the infusion and found in the substance reference record 42. Vitai signs monitored include blood pressure, temperature, pulse rate, oxygen saturation level, etc. Vital signs data may be 25 acquired automaticaly by the SIG infusion system if it is connected to automated vital signs monitoring equipment and the subject is connected to the automated vital signs monitors. Where no automated vital signs monitoring equipment is 42 available, vital sign data may maauay be entered into the SG infusion system. The scheduling of vital sign acquisition and detecting of adverse reaction based on vital signs data is set by parameters in the substance reference record 42 and the programmed protocol. 5 SUBJECT SYMPTOM Subject symptom monitoring is the period acquiston of subject symptoms. Subject symptoms to be monitored and the frequency of monitoring are determined by the institution responible for the infusion and found in the substance reference record 42. Typical subject symptoms monitored include 10 headache, ght-headdnes chills, shObrtness of breath, nausea or vomiting, etc. When prompted by the SiG infusion system, the operator wil determine the subject's condition relative to the symptom being asked by the SIG infusion system. The operator must manually enter the subject symptom responses to the SIG infusion system; there is no automatic entry of subject symptoms. The 15 scheduling of acquisition of subject symptoms and detecting of adverse reaction based on subject symptom data is set by parameters in the substance reference record 42 and programmed protocol. DETECTION AND HANDLING OF ADVERSE REACTIONS Referring to Figure 8, if the substance reference record 42 has been setup 20 to require the acquisition of vital signs data 100 and, according to vital signs monitoring schedule, the acquisition of vital signs is due within two minutes, then the operator is notified of the approaching scheduled vital signs acquisiion by an audible beep and message on the display. When it is time to acquire vital signs 101, a menu is displayed 102 to the operator so indicating. This menu 102 25 includes a selection that allows the operator to skip the acquisition of vital signs If the operator chooses to skip the acquisition of vital signs 103, she must enter an access code and an entry is made to the history ile indicating the acquisition of vital signs was skipped, If the system includes automated vital signs 43 monitoring equipment connected to the SIG infusion system, the S10 infusion system will automatically initiate the acquisition of vital signs data 04; otherwise the operator is prompted to enter the vital signs data 104 on the SG infusion system manually. If the substance reference record 42 has not been setup to 5 require the acquisition of vital data then no prompt or attempt to acquire vital signs is made, If the substance reference record 42 has been setup to require vital sign data be acquire but, according to vital signs monitoring schedule, it Is not time to acquire vital signs, no prompt or attempt to acquire vital signs is made, to if the substance reference record 42 has been setup to require the acquisition of subject symptom responses 105 and if according to the subject symptom query monitoring schedule the acquisition of subject symptom responses is due in two minutes, the operator is notified of the approaching scheduled subject symptom response acquisition by an audible beep and 15 message on the display. When it is time to acquire subject symptom responses 106, a menu is displayed 107 to the operator so indicating. This menu 107 includes a selection that allows the operator to skip the acquisition of subject symptom responses, If the operator chooses to skip the acquisition of subject symptom responses 108, she must enter an access code and an entry is made 20 to the history file indicating the acquisition of subject symptom responses was skipped. If the operator does not skip the acquisition of subject symptom responses, the operator then manually enters '109 the subject symptom responses as prompted by the menu displayed, if the substance reference record 42 has not been setup to require the acquisition of subject symptom 25 responses, then no prompt to acquire subject symptom responses is made, if the substance reference record 42 has been setup to require the acquisition of subject symptom responses but, according to subject symptom monitoring schedule, it is not time to acquire subject symptom responses, no prompt to acquire subject symptom responses is made. 44 if vital signs data and/or subject symptom responses had been acquired 110, they are analyzed according to the limits and parameters setup in the substance reference record 42 associated with the infusion 111. If no adverse reaction is thereby detected 112, the subject is considered sufficiently tolerant of 5 the infusion and a designation of 'green zone" is used to describe the subject's condition. The SIG infusion system will continue to run the infusion while the subject is in a green zone condition, If the subject is suffering a mild adverse reaction 114, as determined by the analysis descibed above, the infusion stops and the subjecfs condition is 10 classified as a "yellow zone" condition 115. For a yellow zone condition, the operator is given the opportunity by the SIG infusion system to retake or enter the vital sign(s) and/or subject symptom(s) 116 related to the reason the mild adverse reaction was detected, if the operator retakes and enters the vital sign(s) and/or subject symptorms(s) 120 the operator is given the opportunity to 15 have the new data analyzed 119 according to the limits and parameters setup in the substance reference record 42, If the operator chooses to anafyZe the new data, processing for detection of adverse reactions starts anew. If the operator chooses not to analyze the new data or if she chooses not to retake vital sign(s) and/or subject symptom(s), the SIG infusion system will sugest a lower infusion 20 rate and allow the operator to accept the lower suggested rate or enter an even lower rate to be used when the infusion is resumed 117. If the operator chooses to use the suggested lower rate or a lower rate she had entered, then the new lower rate is applied 118 and used when the infusion is resumed. If the operator chooses not to use the suggested lowr rate or enter an even lower rate, then 25 the operator is given the opportunity to override the mild adverse reaction advisory 121. If the operator chooses to override the mild adverse reaction advisory, she is required to provide an access code and her action is recorded to a history file 122. If the operator chooses not to override the adverse reaction advisory, she is again given the opportunity to accept the SIG infusion system 30 suggested lower infusion rate or enter an even lower infusion rate. 45 If the subject is suffering a severe adverse reaction 114, as determined by the analysis described above, the infusion stops and the subjects condition is classified as a "red zone" condition 124, For a red zone condition, the operator is given the opportunity by the SIG infusion system to retake and enter the vital 5 sign(s) and/or subject symptom(s) 125 related to the reason the severe adverse reaction was detected. If the operator retakes and enters the vital sign(s) and/or subject symptom(s) 128 the operator is given the opportunity to have the new data analyzed 127 according to the tits and parameters setup in the substance reference record 42. If the operator chooses to analyze the new data 127, 10 processing for detection of adverse rations starts anew. If the operator chooses not to analyze the new data or if she chooses not to retake vital sign(s) and/or subject symptom(s), the infusion is terminated 126 and cannot be resumed. History Database 15 A history files or log is used in the SIG infusion system to record infusion activities, mafunctions, alarms, alerts, advisories and events that may occur whie the SIG infusion system is turned on. The history file records the activities normally associated with setting up and operating the SIC infusion system. Information such the Infusion protocol parameters for an infusion, modifications 20 to an Infusion protocol, occurrences of alerts, alarms and mafunctions, the operator selecting to override of limits or suggestions made by the SIG infusion system, and all activities which required the operator to provide an access code to perform By using an access code, the history file can be reviewed on the SIG infusion system, copied to a personal computer, and printed. In addition, the 25 history file can be cleared by using an authorizing access code, However, though the history file appears cleared to normal operators, its contents prior to clearing are maintained by the SIG infusion system and may be reviewed and retrieved by factory personnel via factory access code. 46 It is to be appreciated that the invention has been described hereabove with reference to certain examples or embodiments of the invention but that various additons, deletions, alterations and modifications may be made to those examples and embodiments without departng from the intended spirit and scope 5 of the invention. For example, any element or attribute of one embodiment or example may be incorporated into or used with another embodiment or example, unless to do so would render the embodiment or example unsuitable for its intended use. Also, where the steps of amethod or process are descibed, listed or aimed in a particular order, such steps may be performed in any other order 10 unless to do so would render the embodiment or example un-nove, obvious to a person of ordinary skill in the relevant art or unsuitable for its intended uae, All reasonable additions, deletions, modifications and alterations are to be considered equivalents of the described examples and embodiments and are to be included within the scope of the following claims 15 417

Claims (10)

1. 2. A method according to claim 1 further comprising the step of: terminating the infusion when the assigned total infusate volume has been delivered.
2. 3. A method according to claim 2 wherein the assigned total infusate volume is reached during an infusion step before the assigned time duration for that infusion step has been reached and wherein the infusion is terminated when the assigned total infusate volume is reached although the assigned time duration for that infusion step has not been reached.
3. 4. A method according to claim I wherein the assigned maximum infusion rate is reached and wherein the method further comprises: continuing the infusion at the assigned maximum infusion rate until the assigned total infusate volume has been delivered.
4. 5. A method according to claim 2 wherein the infusate contains immune globulin.
5. 6. A method according to claim 2 wherein the infusate contains Infliximab, 50 7, A method according to claim 2 wherein the infusion is delivered by an infusion pump system comprising a controller and a pump and wherein parameters assigned in Step A are input to the controller by an operator.
6. 8. A method according to claim 2 wherein the infusion is delivered by an infusion pump system comprising a controller and a pump and wherein parameters assigned in Step A are input to the controller by a reader device that reads those parameters from a source. 9, A method according to claim 8 wherein the source comprises a label or tag attached to or associated with a vessel that contains the infusate.
7. 10. A method according to claim 8 wherein the source comprises a label or tag attached to or associated with the subject to whom the infusion is administered.
8. 11. A method according to claim 8 wherein the source comprises a bar code. 12, A method according to claim 1, further comprising monitoring the subject during each of Steps B through E for an adverse reaction to the infusate and wherein if the subject has an adverse reaction, a controller of an infusion system takes at least one remedial action and wherein if the subject does not have an adverse reaction, the controller continues the profile or performs a subsequent infusion step. 51
9. 13. A method according to claim 1, further comprising monitoring the subject remotely with a remote monitoring and control system.
10. 14. A method according to claim 1, further comprising monitoring the subject remotely by posing a series of specific questions to which the subject responds or by observing physiological variables of the subject. Dated this 16 th day of August 2013 Baxter international Inc. and Baxter Healthcare S.A. Patent Attorneys for the Applicant PETER MAXWELL AND ASSOCIATES