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EquipmentPacket:InfusionPumpUMDNS#:16495DateofCreation:November10,2015Creator:CompliedbyCassandraStancoforEngineeringWorldHealth(EWH)EquipmentPacketContents:Thispacketcontainsinformationabouttheoperation,maintenance,andrepairofinfusionpumps.PartI:ExternalFromthePacket: 1. AnIntroductiontoInfusionPumps:PowerPointPartII:IncludedinthisPacket: 1. OperationandUseofInfusionPumps:a. TheCirculatorySystem(p.3-7)b. IntroductiontoInfusionPumps(p.8-11)c. OverviewoftheRisksofIntravenousTherapy(p.12-14)d. InfusionPumpOperationandUseTips(p.15)2. DiagramsandSchematics:a. Figure1:InfusionPumpSetforInsulin(p.17)3. PreventativeMaintenanceandSafety:a. InfusionPumpPreventativeMaintenance(p.19)b. InfusionPumpSafetyChecklist(p.20)c. ExamplesofIncidentsInvolvingInfusionPumps(p.21)4. TroubleshootingandRepair:a. InfusionPumpTroubleshootingFlowchart(p.23-26)5. SyringePumps:a. IntroductiontoSyringeDrivers(p.28-29)b. Figure2:WHOSyringePumpSpecification(p.30-33)6. ResourcesforMoreInformationa. ResourcesforMoreInformation(p.35)b. Bibliography(p.36)




** 1.*Operation*and*Use*of*Infusion*Pumps****Featured*in*this*Section:****Wikipedia.(“Circulatory(System.”(Wikipedia,(p.(1M9.(Retrieved(from:(https://en.wikipedia.org/wiki/Circulatory_system((((Wikipedia.(“Infusion(Pump.”(Wikipedia,(p.(1M4.(Retrieved(from:(https://en.wikipedia.org/wiki/Infusion_pump(*(* *(* ** *




Circulatory system 1


Circulatory system


Circulatory system


The human circulatory system. Red indicates oxygenated blood, blue indicates deoxygenated.


Latin systema cardiovasculare


The circulatory system is an organ system that passes nutrients (such as amino acids and electrolytes), gases,
hormones, blood cells, etc. to and from cells in the body to help fight diseases and help stabilize body temperature
and pH to maintain homeostasis.


This system may be seen strictly as a blood distribution network, but some consider the circulatory system as
composed of the cardiovascular system, which distributes blood,[1] and the lymphatic system,[2] which distributes
lymph. While humans, as well as other vertebrates, have a closed cardiovascular system (meaning that the blood
never leaves the network of arteries, veins and capillaries), some invertebrate groups have an open cardiovascular
system. The most primitive animal phyla lack circulatory systems. The lymphatic system, on the other hand, is an
open system.


Two types of fluids move through the circulatory system: blood and lymph. The blood, heart, and blood vessels form
the cardiovascular system. The lymph, lymph nodes, and lymph vessels form the lymphatic system. The
cardiovascular system and the lymphatic system collectively make up the circulatory system.


Human cardiovascular system
The main components of the human cardiovascular system are the heart and the blood vessels.[3] It includes: the
pulmonary circulation, a "loop" through the lungs where blood is oxygenated; and the systemic circulation, a "loop"
through the rest of the body to provide oxygenated blood. An average adult contains five to six quarts (roughly 4.7 to
5.7 liters) of blood, which consists of plasma, red blood cells, white blood cells, and platelets. Also, the digestive
system works with the circulatory system to provide the nutrients the system needs to keep the heart pumping.


Pulmonary circulation
The Pulmonary circulation is the portion of the cardiovascular system which transports oxygen-depleted blood away
from the heart, to the lungs, and returns oxygenated blood back to the heart.


Oxygen deprived blood from the vena cava enters the right atrium of the heart and flows through the tricuspid valve
into the right ventricle, from which it is pumped through the pulmonary semilunar valve into the pulmonary arteries
which go to the lungs. Pulmonary veins return the now oxygen-rich blood to the heart, where it enters the left atrium
before flowing through the mitral valve into the left ventricle. Then, oxygen-rich blood from the left ventricle is
pumped out via the aorta, and on to the rest of the body.




Circulatory system 2


Systemic circulation
Systemic circulation is the portion of the cardiovascular system which transports oxygenated blood away from the
heart, to the rest of the body, and returns oxygen-depleted blood back to the heart. Systemic circulation is,
distance-wise, much longer than pulmonary circulation, transporting blood to every part of the body.


Coronary circulation
The coronary circulatory system provides a blood supply to the heart. As it provides oxygenated blood to the heart, it
is by definition a part of the systemic circulatory system.


Heart


View from the front, which means the right side of the heart is on the left of the
diagram (and vice-versa)


The heart pumps oxygenated blood to the
body and deoxygenated blood to the lungs.
In the human heart there is one atrium and
one ventricle for each circulation, and with
both a systemic and a pulmonary circulation
there are four chambers in total: left atrium,
left ventricle, right atrium and right
ventricle. The right atrium is the upper
chamber of the right side of the heart. The
blood that is returned to the right atrium is
deoxygenated (poor in oxygen) and passed
into the right ventricle to be pumped
through the pulmonary artery to the lungs
for re-oxygenation and removal of carbon
dioxide. The left atrium receives newly
oxygenated blood from the lungs as well as
the pulmonary vein which is passed into the
strong left ventricle to be pumped through
the aorta to the different organs of the body.


Closed cardiovascular system


The cardiovascular systems of humans are closed, meaning that the blood never leaves the network of blood vessels.
In contrast, oxygen and nutrients diffuse across the blood vessel layers and enters interstitial fluid, which carries
oxygen and nutrients to the target cells, and carbon dioxide and wastes in the opposite direction. The other
component of the circulatory system, the lymphatic system, is not closed. The heart is located in the center of the
body between the two lungs. The reason that the heart beat is felt on the left side is because the left ventricle, on the
left, is pumping.




Circulatory system 3


Measurement techniques
• Electrocardiogram—for cardiac electrophysiology
• Sphygmomanometer and stethoscope—for blood pressure
• Pulse meter—for cardiac function (heart rate, rhythm, dropped beats)
• Pulse—commonly used to determine the heart rate in absence of certain cardiac pathologies
• Heart rate variability -- used to measure variations of time intervals between heart beats
• Nail bed blanching test—test for perfusion
• Vessel cannula or catheter pressure measurement—pulmonary wedge pressure or in older animal experiments.


Oxygen transportation
About 98.5% of the oxygen in a sample of arterial blood in a healthy human breathing air at sea-level pressure is
chemically combined with haemoglobin molecules. About 1.5% is physically dissolved in the other blood liquids
and not connected to Hgb. The haemoglobin molecule is the primary transporter of oxygen in mammals and many
other species.


Nonhuman


Other vertebrates
The circulatory systems of all vertebrates, as well as of annelids (for example, earthworms) and cephalopods (squid
and octopus) are closed, just as in humans. Still, the systems of fish, amphibians, reptiles, and birds show various
stages of the evolution of the circulatory system.


In fish, the system has only one circuit, with the blood being pumped through the capillaries of the gills and on to the
capillaries of the body tissues. This is known as single cycle circulation. The heart of fish is therefore only a single
pump (consisting of two chambers).


In amphibians and most reptiles, a double circulatory system is used, but the heart is not always completely
separated into two pumps. Amphibians have a three-chambered heart.


In reptiles, the ventricular septum of the heart is incomplete and the pulmonary artery is equipped with a sphincter
muscle. This allows a second possible route of blood flow. Instead of blood flowing through the pulmonary artery to
the lungs, the sphincter may be contracted to divert this blood flow through the incomplete ventricular septum into
the left ventricle and out through the aorta. This means the blood flows from the capillaries to the heart and back to
the capillaries instead of to the lungs. This process is useful to ectothermic (cold-blooded) animals in the regulation
of their body temperature.


Birds and mammals show complete separation of the heart into two pumps, for a total of four heart chambers; it is
thought that the four-chambered heart of birds evolved independently from that of mammals.


Open circulatory system
The Open Circulatory System is a system in which fluid (called hemolymph) in a cavity called the hemocoel bathes
the organs directly with oxygen and nutrients and there is no distinction between blood and interstitial fluid; this
combined fluid is called hemolymph or haemolymph. Muscular movements by the animal during locomotion can
facilitate hemolymph movement, but diverting flow from one area to another is limited. When the heart relaxes,
blood is drawn back toward the heart through open-ended pores (ostia).


Hemolymph fills all of the interior hemocoel of the body and surrounds all cells. Hemolymph is composed of water,
inorganic salts (mostly Na+, Cl-, K+, Mg2+, and Ca2+), and organic compounds (mostly carbohydrates, proteins, and
lipids). The primary oxygen transporter molecule is hemocyanin.




Circulatory system 6


See also
• Microcirculation
• Cardiology
• Lymphatic system
• Blood vessels
• Innate heat
• Cardiac muscle
• Major systems of the human body
• Heart
• Amato Lusitano
• William Harvey


External links
• The Circulatory System Article [11]


• The Circulatory System [12], a comprehensive overview
• NCP Cardiovascular Medicine [13] A Journal Covering Clinical Cardiovascular Medicine


References
[1] cardiovascular system (http:/ / www. mercksource. com/ pp/ us/ cns/ cns_hl_dorlands_split. jsp?pg=/ ppdocs/ us/ common/ dorlands/ dorland/


eight/ 000105264. htm) at Dorland's Medical Dictionary
[2] circulatory system (http:/ / www. mercksource. com/ pp/ us/ cns/ cns_hl_dorlands_split. jsp?pg=/ ppdocs/ us/ common/ dorlands/ dorland/


nine/ 000951445. htm) at Dorland's Medical Dictionary
[3] MeSH Cardiovascular+System (http:/ / www. nlm. nih. gov/ cgi/ mesh/ 2009/ MB_cgi?mode=& term=Cardiovascular+ System)
[4] Dwivedi, Girish & Dwivedi, Shridhar (2007). History of Medicine: Sushruta – the Clinician – Teacher par Excellence (http:/ / medind. nic.


in/ iae/ t07/ i4/ iaet07i4p243. pdf). National Informatics Centre (Government of India).
[5] Anatomy - History of anatomy (http:/ / www. scienceclarified. com/ Al-As/ Anatomy. html)
[6] Mohammadali M. Shojaa, R. Shane Tubbsb, Marios Loukasc, Majid Khalilid, Farid Alakbarlie, Aaron A. Cohen-Gadola (29 May 2009),


"Vasovagal syncope in the Canon of Avicenna: The first mention of carotid artery hypersensitivity", International Journal of Cardiology
(Elsevier) 134 (3): 297–301, doi:10.1016/j.ijcard.2009.02.035


[7] Rachel Hajar (1999), "The Greco-Islamic Pulse", Heart Views 1 (4): 136-140 [138]
[8] Chairman's Reflections (2004), "Traditional Medicine Among Gulf Arabs, Part II: Blood-letting", Heart Views 5 (2), p. 74-85 [80].
[9] West, John B. (October 9, 2008), "Ibn al-Nafis, the pulmonary circulation, and the Islamic Golden Age", Journal of Applied Physiology 105:


1877–80, doi:10.1152/japplphysiol.91171.2008
[10] Peter E. Pormann and E. Savage Smith, Medieval Islamic medicine Georgetown University, Washington DC, 2007, p. 48.
[11] http:/ / www. healthmean. com/ bodysystems/ the-circulatory-system/
[12] http:/ / www. emc. maricopa. edu/ faculty/ farabee/ BIOBK/ BioBookcircSYS. html
[13] http:/ / www. nature. com/ ncpcardio/ index. html




Article Sources and Contributors 7


Article Sources and Contributors
Circulatory system  Source: http://en.wikipedia.org/w/index.php?oldid=356825744  Contributors: -Kerplunk-, 02moat32, 3dscience, 7, A Softer Answer, ABF, Abce2, Abeg92, Abrech, Acc3ss,
Acebulf, Addshore, Adrian J. Hunter, Agent Smith (The Matrix), Ahoerstemeier, Airplaneman, Aitias, Ajaxkroon, Ajmccauley, Ajraddatz, Akral, Aksi great, Alabsinatheer, Alansohn, Aldaron,
Ale jrb, Alex.tan, Alexf, Alexius08, Alissa451, Allen4names, Allstarecho, Alphachimp, AmiDaniel, Amotlein, Amysn, AndreNatas, AndreniW, Andrew Maiman, Andrew walker, Andrij
Kursetsky, Andy M. Wang, Andy corbett, Andycjp, Animeronin, Animum, Anlace, Annerhea, Anonymous Dissident, Anonymous editor, Antandrus, Antonio Lopez, Arcadian,
ArcadianOnUnsecuredLoc, Arey051012, Aryeh, Athenean, Atif.t2, Atlant, Avant Guard, Awwiki, AxelBoldt, Axl, BRUTE, Baby gall, Bachrach44, Ballaholic2k5, Banana04131, Bantman,
Bart133, Bassbonerocks, Bayberrylane, Beano, Belovedfreak, Bensaccount, Beyond silence, Bigjoyo21, Bkonrad, Blah28948, Blurpeace, BobKawanaka, Bobo192, Bogdangiusca, Bogey97,
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Chessphoon, Chizeng, Chris 73, Chris the speller, Chrislk02, Christopher^, Chriswiki, Citicat, Clemwang, Clicketyclack, Closedmouth, Cody574, Coffee, Cometstyles, CommonsDelinker,
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DMacks, DSRH, DVD R W, Da monster under your bed, DaL33T, Dabomb87, Dakchee, Damicatz, Darth Panda, Davewho2, Davewild, David0811, Dawn Bard, Dcfleck, Dcloues, Ddon,
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Sellars, Erich gasboy, Erik9, Erkan Yilmaz, Erol.fazlioglu, Eu.stefan, Euku, Euryalus, Everyguy, Everyking, Evil saltine, Excirial, Exert, Fabiform, Facuq, Falcon8765, Fastily, Faulcon DeLacy,
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Image Sources, Licenses and Contributors
Image:Circulatory System en.svg  Source: http://en.wikipedia.org/w/index.php?title=File:Circulatory_System_en.svg  License: Public Domain  Contributors: User:LadyofHats
File:Diagram of the human heart (cropped).svg  Source: http://en.wikipedia.org/w/index.php?title=File:Diagram of the_human_heart_(cropped).svg  License: GNU Free Documentation
License  Contributors: User:Yaddah
File:Blutkreislauf.png  Source: http://en.wikipedia.org/w/index.php?title=File:Blutkreislauf.png  License: Creative Commons Attribution-Sharealike 2.5  Contributors: User:Sansculotte
File:Circulatory_System_en.png  Source: http://en.wikipedia.org/w/index.php?title=File:Circulatory_System_en.png  License: Public Domain  Contributors: User:KVDP


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Infusion pump 1


Infusion pump


A type of infusion pump, manufactured by Fresenius.


An infusion pump infuses fluids, medication or
nutrients into a patient's circulatory system. It is
generally used intravenously, although subcutaneous,
arterial and epidural infusions are occasionally used.


Infusion pumps can administer fluids in ways that
would be impractically expensive or unreliable if
performed manually by nursing staff. For example,
they can administer as little as 0.1 mL per hour
injections (too small for a drip), injections every
minute, injections with repeated boluses requested by
the patient, up to maximum number per hour (e.g. in
patient-controlled analgesia), or fluids whose volumes
vary by the time of day.


Because they can also produce quite high but controlled
pressures, they can inject controlled amounts of fluids
subcutaneously (beneath the skin), or epidurally (just
within the surface of the central nervous system- a very
popular local spinal anesthesia for childbirth).


Types of infusion
The user interface of pumps usually requests details on the type of infusion from the technician or nurse that sets
them up:


• Continuous infusion usually consists of small pulses of infusion, usually between 500 nanoliters and 10000
microliters, depending on the pump's design, with the rate of these pulses depending on the programmed infusion
speed.


• Intermittent infusion has a "high" infusion rate, alternating with a low programmable infusion rate to keep the
cannula open. The timings are programmable. This mode is often used to administer antibiotics, or other drugs
that can irritate a blood vessel.


• Patient-controlled is infusion on-demand, usually with a preprogrammed ceiling to avoid intoxication. The rate is
controlled by a pressure pad or button that can be activated by the patient. It is the method of choice for
patient-controlled analgesia (PCA), in which repeated small doses of opioid analgesics are delivered, with the
device coded to stop administration before a dose that may cause hazardous respiratory depression is reached.


• Total parenteral nutrition usually requires an infusion curve similar to normal mealtimes.


Some pumps offer modes in which the amounts can be scaled or controlled based on the time of day. This allows for
circadian cycles which may be required for certain types of medication.




Infusion pump 2


Types of pump


A Baxter International Colleague CX infusion
pump


There are two basic classes of pumps. Large volume pumps can pump
nutrient solutions large enough to feed a patient. Small-volume pumps
infuse hormones, such as insulin, or other medicines, such as opiates.


Within these classes, some pumps are designed to be portable, others
are designed to be used in a hospital, and there are special systems for
charity and battlefield use.


Large-volume pumps usually use some form of peristaltic pump.
Classically, they use computer-controlled rollers compressing a
silicone-rubber tube through which the medicine flows. Another
common form is a set of fingers that press on the tube in sequence.


Small-volume pumps usually use a computer-controlled motor turning
a screw that pushes the plunger on a syringe.


The classic medical improvisation for an infusion pump is to place a
blood pressure cuff around a bag of fluid. The battlefield equivalent is
to place the bag under the patient. The pressure on the bag sets the
infusion pressure. The pressure can actually be read-out at the cuff's
indicator. The problem is that the flow varies dramatically with the
patient's blood pressure (or weight), and the needed pressure varies with the administration route, making this quite
risky for use by an untrained person. Pressures into a vein are usually less than 8 lbf/in² (55 kPa. Epidural and
subcutaneous pressures are usually less than 18 lbf/in² (125 kPa).


Places that must provide the least-expensive care often use pressurized infusion systems. One common system has a
purpose-designed plastic "pressure bottle" pressurized with a large disposable plastic syringe. A combined flow
restrictor, air filter and drip chamber helps a nurse set the flow. The parts are reusable, mass-produced sterile plastic,
and can be produced by the same machines that make plastic soft-drink bottles and caps. A pressure bottle, restrictor
and chamber requires more nursing attention than electronically-controlled pumps. In the areas where these are used,
nurses are often volunteers, or very inexpensive.


The restrictor and high pressure helps control the flow better than the improvised schemes because the high pressure
through the small restrictor orifice reduces the variation of flow caused by patients' blood pressures.


An air filter is an essential safety device in a pressure infusor, to keep air out of the patients' veins: doctors estimate
that 0.55 cm³ of air per kilogram of body weight is enough to kill (200–300 cm³ for adults) by filling the patient's
heart. Small bubbles could cause harm in arteries, but in the veins they pass through the heart and leave in the
patients' lungs. The air filter is just a membrane that passes gas but not fluid or pathogens. When a large air bubble
reaches it, it bleeds off.


Some of the smallest infusion pumps use osmotic power. Basically, a bag of salt solution absorbs water through a
membrane, swelling its volume. The bag presses medicine out. The rate is precisely controlled by the salt
concentrations and pump volume. Osmotic pumps are usually recharged with a syringe.


Spring-powered clockwork infusion pumps have been developed, and are sometimes still used in veterinary work
and for ambulatory small-volume pumps. They generally have one spring to power the infusion, and another for the
alarm bell when the infusion completes.


Battlefields often have a need to perfuse large amounts of fluid quickly, with dramatically changing blood pressures
and patient condition. Specialized infusion pumps have been designed for this purpose, although they have not been
deployed.




Infusion pump 3


Many infusion pumps are controlled by a small embedded system. They are carefully designed so that no single
cause of failure can harm the patient. For example, most have batteries in case the wall-socket power fails.
Additional hazards are uncontrolled flow causing an overdose, uncontrolled lack of flow, causing an underdose,
reverse flow, which can siphon blood from a patient, and air in the line, which can starve a patient's tissues of
oxygen if it floats to some part of a patient's body.


Safety features available on some pumps
The range of safety features varies widely with the age and make of the pump. A state of the art pump in 2003 may
have the following safety features:


• Certified to have no single point of failure. That is, no single cause of failure should cause the pump to silently
fail to operate correctly. It should at least stop pumping and make at least an audible error indication. This is a
minimum requirement on all human-rated infusion pumps of whatever age. It is not required for veterinary
infusion pumps.


• Batteries, so the pump can operate if the power fails or is unplugged.
• Anti-free-flow devices prevent blood from draining from the patient, or infusate from freely entering the patient,


when the infusion pump is being set-up.
• A "down pressure" sensor will detect when the patient's vein is blocked, or the line to the patient is kinked. This


may be configurable for high (subcutaneous and epidural) or low (venous) applications.
• An "air-in-line" detector. A typical detector will use an ultrasonic transmitter and receiver to detect when air is


being pumped. Some pumps actually measure the volume, and may even have configurable volumes, from 0.1 to
2 ml of air. None of these amounts can cause harm, but sometimes the air can interfere with the infusion of a
low-dose medicine.


• An "up pressure" sensor can detect when the bag or syringe is empty, or even if the bag or syringe is being
squeezed.


• A drug library with customizable programmable limits for individual drugs that that helps to avoid medication
errors.


• Mechanisms to avoid uncontrolled flow of drugs in large volume pumps (often in combination with a giving st
based free flow clamp) and increasingly also in syringe pumps (piston-brake)


• Many pumps include an internal electronic log of the last several thousand therapy events. These are usually
tagged with the time and date from the pump's clock. Usually, erasing the log is a feature protected by a security
code, specifically to detect staff abuse of the pump or patient.


• Many makes of infusion pump can be configured to display only a small subset of features while they are
operating, in order to prevent tampering by patients, untrained staff and visitors.


See also
• Intravenous drip
• Pharmacy informatics
• Syringe driver
• Research Syringe Pump
• Total parenteral nutrition




Article Sources and Contributors 4


Article Sources and Contributors
Infusion pump  Source: http://en.wikipedia.org/w/index.php?oldid=345045859  Contributors: Ahoerstemeier, Bobblewik, BrokenSphere, Cacycle, CesarB, ClockworkLunch, Cmdrjameson,
Curps, Dieseldrinker, Drooling Sheep, Eequor, Gene Nygaard, Greenrd, Hooperbloob, Jefw83, Jfdwolff, Joshuajohnlee, Karada, Kyoko, L0b0t, Mfranck, Nmnogueira, Ray Van De Walker,
RedWolf, Rich257, Riemann Zeta, Rror, Sceptre, Siva sbj, StaticGull, 37 anonymous edits


Image Sources, Licenses and Contributors
Image:Infusionspumpe.JPG  Source: http://en.wikipedia.org/w/index.php?title=File:Infusionspumpe.JPG  License: GNU Free Documentation License  Contributors: Pflegewiki-User Wü rfel
Image:Baxter Colleague CX infusion pump.JPG  Source: http://en.wikipedia.org/w/index.php?title=File:Baxter_Colleague_CX_infusion_pump.JPG  License: Attribution  Contributors:
User:BrokenSphere


License
Creative Commons Attribution-Share Alike 3.0 Unported
http:/ / creativecommons. org/ licenses/ by-sa/ 3. 0/




Intravenous therapy 7


Risks of intravenous therapy


Infection
Any break in the skin carries a risk of infection. Although IV insertion is an aseptic procedure, skin-dwelling
organisms such as Coagulase-negative staphylococcus or Candida albicans may enter through the insertion site
around the catheter, or bacteria may be accidentally introduced inside the catheter from contaminated equipment.
Moisture introduced to unprotected IV sites through washing or bathing substantially increases the infection risks.


Infection of IV sites is usually local, causing easily visible swelling, redness, and fever. If bacteria do not remain in
one area but spread through the bloodstream, the infection is called septicemia and can be rapid and life-threatening.
An infected central IV poses a higher risk of septicemia, as it can deliver bacteria directly into the central circulation.


Phlebitis
Phlebitis is inflammation of a vein that may be caused by infection, the mere presence of a foreign body (the IV
catheter) or the fluids or medication being given. Symptoms are warmth, swelling, pain, and redness around the vein.
The IV device must be removed and if necessary re-inserted into another extremity.


Due to frequent injections and recurring phlebitis, scar tissue can build up along the vein. The peripheral veins of
intravenous drug addicts, and of cancer patients undergoing chemotherapy, become sclerotic and difficult to access
over time, sometimes forming a hard “venous cord”.


Infiltration
Infiltration occurs when an IV fluid accidentally enters the surrounding tissue rather than the vein. It is characterized
by coolness and pallor to the skin as well as localized swelling or edema. It is usually not painful. It is treated by
removing the intravenous access device and elevating the affected limb so that the collected fluids can drain away.
Infiltration is one of the most common adverse effects of IV therapy and is usually not serious unless the infiltrated
fluid is a medication damaging to the surrounding tissue, in which case the incident is known as extravasation.


Fluid overload
This occurs when fluids are given at a higher rate or in a larger volume than the system can absorb or excrete.
Possible consequences include hypertension, heart failure, and pulmonary edema.


Electrolyte imbalance
Administering a too-dilute or too-concentrated solution can disrupt the patient's balance of sodium, potassium,
magnesium, and other electrolytes. Hospital patients usually receive blood tests to monitor these levels.


Embolism
A blood clot or other solid mass, as well as an air bubble, can be delivered into the circulation through an IV and end
up blocking a vessel; this is called embolism. Peripheral IVs have a low risk of embolism, since large solid masses
cannot travel through a narrow catheter, and it is nearly impossible to inject air through a peripheral IV at a
dangerous rate. The risk is greater with a central IV.


Air bubbles of less than 30 milliliters are thought to dissolve into the circulation harmlessly. Small volumes do not
result in readily detectable symptoms, but ongoing studies hypothesize that these "micro-bubbles" may have some
adverse effects. A larger amount of air, if delivered all at once, can cause life-threatening damage to pulmonary
circulation, or, if extremely large (3-8 milliliters per kilogram of body weight), can stop the heart.


One reason veins are preferred over arteries for intravascular administration is because the flow will pass through the
lungs before passing through the body. Air bubbles can leave the blood through the lungs. A patient with a heart




Intravenous therapy 8


defect causing a right-to-left shunt is vulnerable to embolism from smaller amounts of air. Fatality by air embolism
is vanishingly rare, in part because it is also difficult to diagnose.


Extravasation
Extravasation is the accidental administration of IV infused medicinal drugs into the surrounding tissue which are
caustic to these tissues, either by leakage (e.g. because of brittle veins in very elderly patients), or directly (e.g.
because the needle has punctured the vein and the infusion goes directly into the arm tissue). This occurs more
frequently with chemotherapeutic agents and people who have tuberculosis.


See also
• Life support
• Blood transfusion
• Blood substitutes
• Oral rehydration therapy
• Bolus (medicine)
• Dialysis
• Saline flush
• Hypodermic needle


External links
• Wyeth v. Levine, 06-1249 [3] opinion of US supreme Court - No limit in lawsuits as the result of an injury by


IV-push injection resulting in gangrene and consequent amputation. Gangrene is likely if the injection
accidentally hits an artery — precisely what happened to Levine.


• IVTEAM.com [4]


• Otsuka co [5]


• IV-Therapy.net [6]


• UWash [7]


• Venous Air Embolism by Dr. Andrew G Wittenberg, MD, MPH [8]


• Nursing-Resource, Drip Rate Formulas [9]


References
[1] CDC Morbidity and Mortality Weekly Report Aug 2002. "Guidelines for the Prevention of Intravascular Catheter-Related Infections" (http:/ /


www. cdc. gov/ mmwr/ preview/ mmwrhtml/ rr5110a1. htm). . Retrieved 2008-03-13.
[2] An Update on Intravenous Fluids (http:/ / www. medscape. com/ viewarticle/ 503138) by Gregory S. Martin, MD, MSc
[3] http:/ / news. yahoo. com/ s/ ap/ 20090304/ ap_on_bi_ge/ scotus_drug_suit;_ylt=Aub59VlL9B5dNx.


hlt7XV9is0NUE;_ylu=X3oDMTJiMHNzOWFxBGFzc2V0A2FwLzIwMDkwMzA0L3Njb3R1c19kcnVnX3N1aXQEcG9zAzExBHNlYwN5bl90b3Bfc3RvcnkEc2xrA3N1cHJlbWVjb3VydA--
[4] http:/ / www. ivteam. com
[5] http:/ / www. otsuka. co. id
[6] http:/ / www. iv-therapy. net
[7] http:/ / healthlinks. washington. edu/ nutrition/ section6. html
[8] http:/ / emedicine. medscape. com/ article/ 761367-overview
[9] http:/ / nursing-resource. com/ drip-rate




Article Sources and Contributors 9


Article Sources and Contributors
Intravenous therapy  Source: http://en.wikipedia.org/w/index.php?oldid=358682553  Contributors: A-giau, A. B., Acdx, Adam Schwing, Aerno, Albval, Alex Whittaker, Alex.tan, Anthony
Appleyard, Arcadian, Arfgab, Badgettrg, Bbpen, Benlisquare, BennyK95, Bonnief, Bouchecl, Bzagga, Calmer Waters, Caltas, Carlo Banez, Cburnett, Chris 73, Corta, Cynix, DanielCD, David
spector, Deathawk, Djhaloeight, Donfbreed, Doulos Christos, Drooling Sheep, Dybdal, Edgar181, Emvee, Epbr123, Erich gasboy, Frenkmelk, Fuhghettaboutit, Graham87, HalJor, Hob, Hu12,
Hux, InvictaHOG, Iridescent, Irishguy, Ivteam, Iyan Darmawan, Iyan Darmawan Purnomo, J.P.Lon, Jbyers2, Jeff Muscato, Jehochman, Jersey emt, Jfdwolff, Jh12, Joshuajohnlee, Jsc83, Julesd,
KJ Sam, Kenkoo1987, Kevinsmith99, Kosebamse, KrakatoaKatie, Kyoko, LAX, Liyster, LongIsland, Longhair, MPerel, Manop, Marinov84, Martin451, Mathlosopher, Mattbrundage, Mattisse,
Medifix, Mercury, Mfranck, Michael Devore, Michael shaw, Michaelberry, Midnightvisions, Mikael Häggström, Minimac, Mushroom, Narayanese, Natrego, Nick, Nunh-huh, OldakQuill,
PARAMEDIC, Patrick, Quadell, Ray Van De Walker, Reach Out to the Truth, Rencomed, Ronz, Rrburke, Rtbecker01, Sbmehta, Securiger, Shadypalm88, Sherool, Signora con l'ombrello,
Sithu.Win, Skittleys, Snowmanradio, Soixantieme, Spiral5800, Spolster, Ssbohio, Tempodivalse, The Cunctator, Theodore Kloba, Thumperward, Tim Starling, Tocharianne, Tompot, Tres, Uncle
Dick, Ursa Gamma, Uthbrian, Wavelength, WhatamIdoing, Whlegallee, Wik, Wouterstomp, Yuanfangdotdot, 239 anonymous edits


Image Sources, Licenses and Contributors
File:Infuuszakjes.jpg  Source: http://en.wikipedia.org/w/index.php?title=File:Infuuszakjes.jpg  License: Public Domain  Contributors: User:Harmid
Image:Intravenous therapy 2007-SEP-13-Singapore.JPG  Source: http://en.wikipedia.org/w/index.php?title=File:Intravenous_therapy_2007-SEP-13-Singapore.JPG  License: Creative
Commons Attribution 3.0  Contributors: Original uploader was Michaelberry at en.wikipedia
File:Intravenous attempt.jpg  Source: http://en.wikipedia.org/w/index.php?title=File:Intravenous_attempt.jpg  License: Public Domain  Contributors: User:Rjgalindo
File:Iv1-07 014.jpg  Source: http://en.wikipedia.org/w/index.php?title=File:Iv1-07_014.jpg  License: GNU Free Documentation License  Contributors: El., J.P.Lon, Matanya, Una Smith
File:Infuuspomp.jpg  Source: http://en.wikipedia.org/w/index.php?title=File:Infuuspomp.jpg  License: Public Domain  Contributors: User:Harmid


License
Creative Commons Attribution-Share Alike 3.0 Unported
http:/ / creativecommons. org/ licenses/ by-sa/ 3. 0/




Table 2 Action required by infusion pump users


When? Action


Before use •







Check that leads, administration sets, bags and cassettes or syringes
are in good working order and properly assembled/loaded.
Carry out relevant functional and calibration checks (start-up checks).
Note results.
Check control settings.
Check that correct flow rate has been set.


A problem occurs •






Stop the infusion. Make sure that all clamps on the giving sets are
closed.


Seek technical advice.
Record problems and action taken.
If necessary, withdraw the device from service.


At specified
intervals








Check that the observed flow rate corresponds to the rate displayed on
the infusion pump.


Inspect infusion site.
Note results.
If checks fail, withdraw the device from service if necessary.


After use




Clean as recommended by the manufacturer.
Safely dispose of single-use devices and other accessories that cannot
be reused.


When sending an
infusion system
to be repaired or
serviced







Include all the leads and accessories needed to operate the device.
Enclose a full account of any problems and faults.
Decontaminate.
Fill in decontamination form.


When an infusion
device has
undergone
service




Carry out all standard pre-use inspections.
Check the set-up of protocols and programs, as these may have been
altered during servicing.


When an adverse
incident has
occurred (see
section 3.4 for
what should be
reported to the
MHRA)


First take steps necessary for the well being of the patient and/or staff, then:











Do not alter settings or remove administration sets.
Leave any fluids in the infusion system if possible.
Note details of all medical equipment attached to the patient.
Note details of device: type, make, model and serial number.
Retain packaging for details of consumables.
Note setting of controls and limits of alarms.
Note the content volume remaining in the bag, container, set or syringe.
If relevant, record the contents of computer memory logs of the infusion
pump. Seek the assistance of the electrical biomedical engineering
(EBME) department if necessary.


If possible, contact the MHRA before moving or dismantling the
equipment.




Infusion Systems DB 2003(02) v2.0 November 2010 23/56




2.*Diagrams*and*Schematics*of*Infusion*Pumps*****Featured*in*this*Section:*****Wikimedia.(“Insulin(Pump(and(Infusion(Set.”(Wikimedia(Commons.(Posted(July(22,(2007.(Retrieved(from:(https://commons.wikimedia.org/wiki/File:Insulin_pump_and_infusion_set.JPG(*** *






3.*Preventative*Maintenance*and*Safety*of*Infusion*Pumps****Featured*in*this*Section:******Cooper,(Justin(and(Alex(Dahinten(for(EWH.(“Infusion(Pump(Preventative(Maintenance.”(From(the(publication:((Medical(Equipment(Troubleshooting(Flowchart(Handbook.(Durham,(NC:(Engineering(World(Health,(2013.(( *Department(of(Health,(Social(Services(and(Public(Safety.(“Device(Bulletin:(Infusion(Systems(DB,(v2.0.”(Vol.(DB2003,(No.(2.(Department(of(Health,(Social(Services(and(Public(Safety,(2010,(p.(1M56.(((* ** *




EQUIPMENT)Infusion(Pump(Preventative(Maintenance)) Preventive(Maintenance(Checklist()Syringe((IV)(pumps:(1. Examine(plug(and(line(cord.(2. Examine(internal(cables(and(connectors.(3. Verify(software(and(menu(settings(are(appropriate(for(clinical(application.(4. Examine(controls(and(switches(for(proper(function.(5. Verify(battery(chargers(and(indicators(are(working(6. Check(replacement(date(for(battery.(Replace(battery(if(necessary.(7. Confirm(lights,(indicators,(and(displays(are(working.(8. Verify(flow(stops(when(device(is(turned(off.(9. If(device(requires(the(IV(set(to(be(closed(before(it(is(disconnected,(verify(this(mechanism(is(operating.(10. Calibrate(machine(for(flow(rate.(11. Check(for(unusual(noise(or(vibration.(12. Run(selfOtest,(if(equipped.(13. Lubricate(lead(screw,(gears,(and(other(moving(parts(as(required.(14. Measure(chassis(leakage(current(15. Measure(ground(resistance.(16. Test(audible(and(visual(alarms(and(indicators.((Feeding(pumps:(1. Clean(machine(and(chassis(of(any(enteral(solution(residue.(2. Examine(plug(and(line(cord.(3. Examine(internal(cables(and(connectors.(4. Verify(software(and(menu(settings.(5. Examine(controls(and(switches(for(proper(function.(6. Verify(battery(chargers(and(indicators(are(working.(7. Check(replacement(date(for(the(battery.((Replace(battery(if(necessary.(8. Confirm(lights,(indicators,(and(displays(are(working.(9. Verify(flow(stops(when(device(is(turned(off.(10. Calibrate(machine(for(flow(rate.(11. Check(for(unusual(noise(or(vibration.(12. Check(rollers(and(tubing(to(see(if(replacement(is(necessary.(13. Run(selfOtest,(if(equipped.(14. Lubricate(any(rollers(or(actuators(as(necessary.(15. Measure(chassis(leakage(current.(16. Measure(ground(resistance(17. Test(audible(and(visual(alarms(and(indicators.((




Infusion Pumps- Safety & Performance ["""]"Inspect"exterior"of"equipment"for"damage"or"missing"hardware."["""]"Inspect"the"power"cord,"strain"relief"and"plug/s"for"any"signs"of"damage."["""]"Turn"unit"off,"open"user>accessible"covers"and"inspect"unit"for"damage."["""]"Clean"unit"interior"components"and"exterior"with"vacuum"or"compressed"air."["""]"Inspect"interior"for"signs"of"corrosion"or"missing"hardware."Repair"as"required."["""]"Inspect"electrical"components"for"signs"of"excessive"heat"or"deterioration."["""]"Perform"battery"operation"test."["""]"Test"instrument"service/test"mode."["""]"Verify"pressure"calibration."["""]"Perform"auto"pinch>off"test."["""]"Verify"rate"accuracy."["""]"Verify"correct"operation"of"all"buttons,"controls,"displays"and/or"indicators."["""]"Verify"correct"operation"of"unit"in"all"functional"modalities.""




Table 1 Examples of types of incidents involving infusion pumps


Category of incident Examples of incidents


Storage / packaging
● Flat battery due to not charging the pump.
● Set packaging damaged – set contaminated.


Maintenance


● Loss of battery capacity because battery not maintained
according to manufacturer’s instructions.
● Incorrectly replaced seal resulting in fluid ingress.
● Free-flow from volumetric pump because the door contacts
were not checked during the pump’s annual maintenance.


Contamination
● Fluid ingress into infusion pump.
● Dried infusate on syringe size sensor resulting in incorrect
syringe size being displayed by the pump.


Degradation
● Set worn out – inaccurate infusion.
● Worn pumping mechanism leading to inaccurate infusion.


Damage
Pumping mechanism became loose because the pump was
dropped. The loose mechanism could not hold the set against
the door sufficiently to control the flow.


Performance Infusion pump not performing to specification because the manufacturer had incorrectly set the pumping mechanism.


Design and labelling
A reprint of the user instructions specified a zero instead of the
number one to set the KVO. Users following the new
instructions could not set the pump to KVO.


Quality assurance (QA)
Spare components for detecting when the infusion was near its
end were undersize. If fitted the pump would not signal ‘near
end of infusion’.


User errors ● Misloading administration set.
● Misloading the syringe.
● Setting the wrong rate.
● Confusing primary and secondary rates.
● Not confirming the set rate.
● Not confirming the syringe size.
● Confusing the pump type.
● Not stopping the infusion correctly.
● Not confirming the pump mode.
● Not confirming the configuration of the pump.




Infusion Systems DB 2003(02) v2.0 November 2010 7/56




4.*Troubleshooting*and*Repair*of*Infusion*Pumps*****Featured*in*this*Section:****Cooper,(Justin(and(Alex(Dahinten(for(EWH.(“Infusion(Pump(Troubleshooting(Flowchart.”(From(the(publication:(Medical(Equipment(Troubleshooting(Flowchart(Handbook.(Durham,(NC:(Engineering(World(Health,(2013.( *




EQUIPMENT)Infusion)Pump)Troubleshooting)! Diagnostic*flowchart*(Syringe*Pumps)*Syringe!pumps!use!a!syringe!driven!by!a!lead!screw!to!deliver!precise!amounts!of!liquid!medication!intravenously.!!


!




!!#" Text"box" Explanation"or"Comment"1! Begin:!IV!infusion!pump!(syringe)! Start!the!diagnostic!process.!2! Device!turns!on?! Displays,!lights,!and!sounds!indicate!the!machine!has!turned!on.!3! Troubleshoot!power!supply!(separate!flowchart).! Syringe!pumps!generally!have!an!ACIDC!power!supply.!4! Replace!battery!if!necessary.! Old!batteries!are!a!common!problem!with!syringe!pump!batteries.!5! Device!runs!on!battery!only!(no!AC)?! Check!if!the!machine!will!run!on!battery!when!power!is!unplugged.!This!is!a!safety!feature!on!many!syringe!pumps.!6! Pump!creates!correct!flow!rate?! Measure!the!flow!rate!using!a!container!of!knownIvolume!to!collect!the!fluid!and!a!stopwatch.!For!small!flow!rates,!it!may!be!necessary!to!use!a!precision!scale!to!measure!the!fluid!output.!Flow!rate!is!volume!divided!by!time.!7! Is!flow!rate!zero?! Check!if!the!machine!will!generate!any!output!of!fluid.!8! Is!flow!rate!too!high?! Compare!the!measured!flow!rate!to!the!amount!programmed!in!the!machine.!9! Confirm!clutch!is!not!slipping.! Low!flow!can!be!caused!by!a!clutch!slipping!on!the!lead!screw.!Repair!if!necessary.!10! Clean!and!lubricate!lead!screw!as!necessary.! See!BTA!skills!on!cleaning!and!lubrication.!11! Confirm!syringe!is!loaded!properly.! Incorrect!flow!rate!can!be!caused!by!improperly!loaded!syringe.!12! Confirm!cables!to!and!from!sensors!and!motor!are!seated!properly.! See!BTA!skills!on!electric!connections!and!connectors.!13! Replace/calibrate!sensors!as!necessary:!syringe!position!sensor,!and!syringe!size!sensor!(if!applicable).!
Faulty!sensors!can!cause!faults!in!controlling!the!flow!rate.!


14! Is!flow!rate!correct?! Measure!the!flow!rate!using!a!container!of!knownIvolume!to!collect!the!fluid!and!a!stopwatch.!For!small!flow!rates,!it!may!be!necessary!to!use!a!precision!scale!to!measure!the!fluid!output.!15! There!may!be!a!fault!with!microprocessor.! Possible!problem!with!the!microprocessor!or!computing!software.!




16! Consider!replacing/disposing.! If!the!problem!lies!with!the!microprocessor,!the!machine!may!need!to!be!disposed!and!replaced.!17! Confirm!syringe!is!loaded!properly.! Incorrect!flow!rate!can!be!caused!by!improperly!loaded!syringe.!18! Confirm!proper!menu!settings!and!options!are!in!use.! User!error!may!be!a!problem!if!machine!is!reported!for!lack!of!flow.!19! Clean!and!lubricate!lead!screw!as!necessary.! See!BTA!skills!on!cleaning!and!lubrication.!20! Is!flow!rate!zero?! Check!if!the!machine!will!generate!any!output!of!fluid.!21! Repair!or!replace!stepper!motor.! If!corrective!measures!don't!start!fluid!output,!there!may!be!a!problem!with!the!motor!that!drives!the!syringe.!22! Flow!ceases!when!syringe!pump!is!off?! Verify!that!the!flow!ends!when!the!pump!is!turned!off!or!the!control!panel!is!used!to!end!the!flow.!23! Confirm!syringe!is!loaded!properly.! An!incorrectly!loaded!syringe!could!leak!fluid!when!flow!is!turned!off!by!controls.!24! Correct!leaks!in!tubing.! See!BTA!skills!on!plumbing!leaks.!25! Confirm!syringe!plunger!will!not!move!freely!without!motor.! If!plunger!moves!independently!of!machine!controls,!check!mechanical!connections.!26! Does!high!pressure!alarm!sound!when!tube!is!pinched!after!syringe?! If!the!output!tube!is!occluded,!the!machine!should!emit!a!high!pressure!alarm.!27! Is!machine!always!silent?! Investigate!if!machine!makes!noises!due!to!any!other!inputs!or!alarms.!28! Replace/calibrate!force!sensor!on!syringe!plunger.! High!pressure!alarm!is!not!sounding.!Check!the!force!sensor!that!measures!the!force!applied!to!the!syringe!plunger.!29! Ensure!force!sensor!cables!are!properly!connected!and!seated.! See!BTA!skills!on!electric!connections!and!connectors.!30! Replace!speaker.! Machine!is!not!in!silent!mode,!but!it!does!not!make!noise.!Replace!the!speaker.!31! Go!to!begin.! Restart!the!diagnostic!process!to!see!if!the!corrective!measures!have!repaired!the!machine.!32! Go!to!begin.! Restart!the!diagnostic!process!to!see!if!the!corrective!measures!have!repaired!the!machine.!33! IV!pump!is!working!properly.! Return!the!machine!to!service!via!the!appropriate!clinical!personnel.!34! Verify!machine!not!in!silent!mode.! Silent!mode!may!be!preventing!the!alarm.!Turn!off!silent!mode!and!check!alarm!again.!




31! Go!to!begin.! Restart!the!diagnostic!process!to!see!if!the!corrective!measures!have!repaired!the!machine.!32! Feeding!pump!is!working!properly.! Return!the!machine!to!service!via!the!appropriate!clinical!personnel.!33! Check!if!machine!is!in!silent!mode.! Silent!mode!may!be!preventing!the!alarm.!Turn!off!silent!mode!and!check!alarm!again.!)




5.*Syringe*Pumps****Featured*in*this*Section:*** (((((((((**WHO.(“Syringe(Pump.”(From(the(publication:(“WHO(Technical(Specifications(for(61(Medical(Devices.(WHO.(Retrieved(from:(http://www.who.int/medical_devices/management_use/mde_tech_spec/en/(((Wikipedia.(“Syringe(Driver.”(Wikipedia,(p.(1M2.(Retrieved(from:(http://en.wikipedia.org/wiki/Syringe_driver** *




Syringe driver 1


Syringe driver


A syringe pump for laboratory use. World
Precision Instruments (WPI) SP120PZ.


A syringe driver or syringe pump is a small infusion pump (some
include infuse and withdraw capability), used to gradually administer
small amounts of fluid (with or without medication) to a patient or for
use in chemical and biomedical research.


The most popular use of syringe drivers is in palliative care, to
continuously administer analgesics (painkillers), antiemetics
(medication to suppress nausea and vomiting) and other drugs. This
prevents periods during which medication levels in the blood are too
high or too low, and avoids the use of multiple tablets (especially in
people who have difficulty swallowing). As the medication is
administered subcutaneously, the area for administration is practically limitless, although edema may interfere with
the action of some drugs.


Syringe drivers are also useful for delivering IV medications over several minutes. In the case of a medication which
should be slowly pushed in over the course of several minutes, this device saves staff time and reduces errors.


Syringe pumps are also useful in microfluidic applications, such as microreactor design and testing, and also in
chemistry for slow incorporation of a fixed volume of fluid into a solution. In enzyme kinetics syringe drivers can be
used to observe rapid kinetics as part of a stopped-flow apparatus.[1]


External links
• Picture of syringe driver in use [2]


References
[1] Fersht, Alan (1985). Enzyme structure and mechanism. San Francisco: W.H. Freeman. pp. 123. ISBN 0-7167-1614-3.
[2] http:/ / www. mja. com. au/ public/ issues/ 178_10_190503/ rey10533_fm-1. jpg




Article Sources and Contributors 2


Article Sources and Contributors
Syringe driver  Source: http://en.wikipedia.org/w/index.php?oldid=345412572  Contributors: C4 Diesel, Greenrd, Hooperbloob, Jefw83, Jfdwolff, Jheald, MER-C, Mikiemike, Nmnogueira,
Passingtramp, Phantomsteve, Rich Farmbrough, Rsostek, Stmrocket, Syringepump, TimVickers, WhatamIdoing, 18 anonymous edits


Image Sources, Licenses and Contributors
Image:Syringe pump.jpg  Source: http://en.wikipedia.org/w/index.php?title=File:Syringe_pump.jpg  License: Creative Commons Attribution-Sharealike 2.5  Contributors: User:Nmnogueira


License
Creative Commons Attribution-Share Alike 3.0 Unported
http:/ / creativecommons. org/ licenses/ by-sa/ 3. 0/




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1 WHO Category / Code (under development)2 Generic name Syringe Pump3 Specific type or variation (optional) N/A4 GMDN name Syringe pump5 GMDN code 132176 GMDN category 02 Anaesthetic and respiratory devices 04 Electro mechanical medical devices11 Assistive products for persons with disability 7 UMDNS name Infusion Pumps, Syringe 8 UMDNS code 132179 UNSPS code (optional)10 Alternative name/s (optional) Syringe Drivers; Driver, syringe; Infusion pump, syringe11 Alternative code/s (optional) S 18092; S 4641912 Keywords (optional) analgesia, analgesia, drug, syringe driver13 GMDN/UMDNS definition (optional)
A device designed to precisely drive the plunger of a syringe down its barrel to infuse a solution when it must be administered with a high degree of volume accuracy and rate consistency. Because of the lower flow settings and flow resolution, it is especially appropriate for neonatal, infant, and critical care applications in which small volumes of concentrated drugs are to be delivered over an extended period. It can also be used to administer epidural analgesia. 14 Clinical or other purpose Designed to precisely drive the plunger of a syringe down its barrel to infuse a solution when it must be administered with a high degree of volume accuracy and rate consistency.15 Level of use (if relevant) Health centre, district hospital, provincial hospital, specialized hospital16 Clinical department/ward(if relevant) Intensive care unit (ICU), radiology department, emergencies, operating theatres ...17 Overview of functional requirements A syringe containing medication is securely mounted on the drive arm. The drive arm infuses the medication at a steady, programmed rate.Alarms indicate if any error situations occur.18 Detailed requirements 1. Infusion pump with one channel.2. Capable of accept any kind of fluids (as solutions and medicines).3. Must work on commonly available 20, 50 and 60 ml syringes.4. Control panel.5. Accuracy of ±2% or better.6. Maximum pressure generated ≤ 20 psi.7. Automatic detection of syringe size and proper fixing.8. Must provide alarm for wrong loading of syringe.9. Anti-bolus system to reduce pressure on sudden release of occlusion.10. Pause infusion facility required.11. Self-check carried out on powering on.12. Events stored system.13. Battery with operating time at least 6 hours.19 Displayed parameters Comprehensive alarm package required including: occlusion alarm, plunger disengaged, syringe loading error, flow error, syringe unlocked, infusion complete, near end of infusion pre-alarm and alarm, volume limit pre-alarm and alarm, low battery pre-alarm and alarm, AC power failure, maintenance required.


NAME, CATEGORY AND CODING


PURPOSE OF USE


TECHNICAL CHARACTERISTICS




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20 User adjustable settings 1. Flow rate programmable range at least from 0.1 to 200 ml/hr, in steps of 0.1 ml/hr; and at least from 100 to 1200 ml/hr in steps of 1 ml/hr.2. Flow rate or volume limit to administer from 0.1 to 999.9 ml. 3. Saves last infusion rate even when the AC power is switched off.4. Bolus rate should be programmable to approx. 500 ml, with infused volume display. 5. Selectable occlusion pressure trigger levels selectable from 300, 500 and 900 mmHg.21 Components(if relevant) N/A22 Mobility, portability(if relevant) Portable, Securely mountable on table-top, IV stand or bed fitting23 Raw Materials(if relevant) Tamper-resistant case made of impact resistant material24 Electrical, water and/or gas supply (if relevant) 1. Power input to be ******* fitted with ******* compatible mains plug.2. Internal rechargeable battery having at least 5 hours backup for 10ml/hr flow rate with 50ml syringe.3. Battery powered alarm for power failure or disconnection.
25 Accessories (if relevant) Clamp for mounting pump on IV stand26 Sterilization process for accessories (if relevant) Autoclavable temperature sensor27 Consumables / reagents (if relevant) Disposable syringes of different kind of volumes.28 Spare parts (if relevant) Medical units select them according to their needs, ensuring compatibility with the brand and model of the equipment.29 Other components (if relevant) N/A30 Sterility status on delivery (if relevant) N/A31 Shelf life (if relevant) N/A32 Transportation and storage (if relevant) N/A33 Labelling (if relevant) N/A34 Context-dependent requirements 1. Capable of being stored continuously in ambient temperature of 0 to 50 deg C and relative humidity of 15 to 90%.2. Capable of operating continuously in ambient temperature of 10 to 40 deg C and relative humidity of 15 to 90%.35 Pre-installation requirements(if relevant) Supplier to perform installation, safety and operation checks before handover.36 Requirements for commissioning (if relevant) Local clinical staff to affirm completion of installation37 Training of user/s (if relevant) Training of users in operation and basic maintenance shall be provided38 User care(if relevant) Enclosure to protect against water ingress.Capable of cleaning with alcohol or chlorine wipes.39 Warranty 2 years40 Maintenance tasks Preventive/periodic maintenance requirements to be listed.


UTILITY REQUIREMENTS
PHYSICAL/CHEMICAL CHARACTERISTICS


ACCESSORIES, CONSUMABLES, SPARE PARTS, OTHER COMPONENTS


PACKAGING
ENVIRONMENTAL REQUIREMENTS
TRAINING, INSTALLATION AND UTILISATION


WARRANTY AND MAINTENANCE




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41 Type of service contract N/A42 Spare parts availability post-warranty N/A43 Software / Hardware upgrade availability N/A44 Documentation requirements 1. Advanced maintenance and calibration tasks required shall be documented.2. User, technical and maintenance manuals to be supplied in (***** language).3. List to be provided of equipment and procedures required for local calibration and routine maintenance.4. List to be provided of important spares and accessories, with their part numbers and cost. 5. Certificate of calibration and inspection to be provided.
45 Estimated Life Span 8 to 10 years.46 Risk Classification Class C (GHTF Rule 11-1); Class II (USA); Class II a (EU and Australia); Class III (Japan and Canada)47 Regulatory Approval / Certification FDA approval (USA); CE mark (EU)48 International standards ISO 13485:2003 Medical devices -- Quality management systems -- Requirements for regulatory purposes (Australia, Canada and EU)ISO 14971:2007 Medical devices -- Application of risk management to medical devicesIEC 60601-1:2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performanceIEC 60601-1-1:2000 Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systemsIEC 60601-1-2:2007 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and testsIEC 60601-2-24 Ed. 2.0:2012 (b) Medical electrical equipment - Part 2-24: Particular requirements for the basic safety and essential performance of infusion pumps and controllersISO 7886-2:1996 Sterile hypodermic syringes for single use -- Part 2: Syringes for use with power-driven syringe pumpsISO 8536-8:2004 Infusion equipment for medical use -- Part 8: Infusion equipment for use with pressure infusion apparatusISO 8536-9:2004 Infusion equipment for medical use -- Part 9: Fluid lines for use with pressure infusion equipmentISO 8536-10:2004 Infusion equipment for medical use -- Part 10: Accessories for fluid lines for use with pressure infusion equipmentISO 8536-11:2004 Infusion equipment for medical use -- Part 11: Infusion filters for use with pressure infusion equipmentISO 8536-12:2007 Infusion equipment for medical use -- Part 12: Check valvesISO 9626:1991 Stainless steel needle tubing for the manufacture of medical devicesISO 23908:2011 Sharps injury protection -- Requirements and test methods -- Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood samplingISO 26825:2008 Anaesthetic and respiratory equipment -- User-applied labels for syringes containing drugs used during anaesthesia -- Colours, design and performance
49 Reginal / Local Standards EU standardsEN 60601-2-24:1998 Medical electrical equipment - Part 2-24: Particular requirements for the safety of infusion pumps and controllers


DECOMMISSIONINGSAFETY AND STANDARDS


DOCUMENTATION




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50 Regulations US regulations21 CFR part 82021CFR section 880.5725 pump, infusionEU regulationsCouncil Directive 93/42/EEC Directive 93/68/EEC (CE Marking)Directive 98/79/ECDirective 2001/104/EC Directive 2007/47/ECJapan regulationsMHLW Ordinance No.16913217000 Syringe infusion pump




** 6.*Resources*for*More*Information*about*Infusion*Pumps****Featured*in*this*Section:****Malkin,(Robert.(“Fluid(Pump:(Use(and(Operation.”(Medical(Instrumentation(in(the(Developing(World.(Engineering(World(Health,(2006.(( *(( (**((((* *((((




*Resources*for*More*Information:(*((Internal*Resources*at*library.ewh.org:*For*More*Information*about*Infusion*pumps,*please*see*this*resource*in*the*BMET*Library!*( 1. Malkin,(Robert.(“Fluid(Pump:(Use(and(Operation.”(Medical(Instrumentation(in(the(Developing(World.(Engineering(World(Health,(2006.((((




Infusion*Pump*Bibliography:(((Department(of(Health,(Social(Services(and(Public(Safety.(“Device(Bulletin:(Infusion(Systems(DB,(v2.0.”(Vol.(DB2003,(No.(2.(Department(of(Health,(Social(Services(and(Public(Safety,(2010,(p.(1M56.((((((Cooper,(Justin(and(Alex(Dahinten(for(EWH.(“Infusion(Pump(Preventative(Maintenance.”(From(the(publication:((Medical(Equipment(Troubleshooting(Flowchart(Handbook.(Durham,(NC:(Engineering(World(Health,(2013.(((Cooper,(Justin(and(Alex(Dahinten(for(EWH.(“Infusion(Pump(Troubleshooting(Flowchart.”(From(the(publication:(Medical(Equipment(Troubleshooting(Flowchart(Handbook.(Durham,(NC:(Engineering(World(Health,(2013.(*Wikimedia.(“Insulin(Pump(and(Infusion(Set.”(Wikimedia(Commons.(Posted(July(22,(2007.(Retrieved(from:(https://commons.wikimedia.org/wiki/File:Insulin_pump_and_infusion_set.JPG(((Wikipedia.(“Circulatory(System.”(Wikipedia,(p.(1M9.(Retrieved(from:(https://en.wikipedia.org/wiki/Circulatory_system(((Wikipedia.(“Infusion(Pump.”(Wikipedia,(p.(1M4.(Retrieved(from:(https://en.wikipedia.org/wiki/Infusion_pump(*Wikipedia.(“Syringe(Driver.”(Wikipedia,(p.(1M2.(Retrieved(from:(http://en.wikipedia.org/wiki/Syringe_driver(*WHO.(“Syringe(Pump.”(From(the(publication:(“WHO(Technical(Specifications(for(61(Medical(Devices.(WHO.(Retrieved(from:(http://www.who.int/medical_devices/management_use/mde_tech_spec/en/(****




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