T34 TM. Syringe Pump System Operator Manual

Transcription

1 T34 TM Syringe Pump System Operatr Manual 0344 Caesarea Medical Electrnics Ltd. 16 Shacham street Industrial Park Caesarea Nrth P.O.Bx 4294 Caesarea 38900, Israel E: W: MedNet GmbH. Brkstrasse Muenster Germany T: Sftware Versin NCAT / NCATBOL 1

2 Cntents SECTION 1: GENERAL INFORMATION Preface Abut this manual Advisry terms and perating precautins Intended use Cntraindicatins System symbls Syringe pump specificatins Limited Warranty Pump inspectin and unpacking... 9 SECTION 2: DISPOSABLES AND ACCESSORIES Syringe brands and sizes Administratin sets Battery pwer supply Lckbx Carry Puches SECTION 3: PUMP FEATURES AND DESCRIPTION Overview Pump descriptin Event Lg Pst Occlusin Blus Reductin System (POBRS) SECTION 4: MODES OF OPERATION Mdes f peratin SECTION 5: PUMP CONFIGURATION Pump cnfiguratin Pump access cdes Pump INFO and cnfiguratin menus Pump Cnfigurable settings fr mdes f peratin Optinal cnfigurable settings Practise scenaris fr changing pump cnfiguratin SECTION 6: STARTING A NEW INFUSION Sequence fr starting an infusin SECTION 7: MONITORING AND MANAGING INFUSIONS Pump and infusin safety checks Keypad lck Prgram prtectin and Resume Stpping/pausing the infusin and pwering ff Alerts, alarms and trubleshting Changing syringes/administratin sets Servicing and maintenance Sftware Versin NCAT / NCATBOL 2

3 SECTION 1: GENERAL INFORMATION 1.1 Preface Duplicatin r distributin f this manual and any infrmatin cntained within is strictly prhibited withut the express written permissin f CME Ltd. This manual and any infrmatin cntained within, may nt be reprduced, distributed, r transmitted in any frm, r by any means, fr any purpse, withut the express written permissin f CME Ltd. T rder additinal cpies f this manual, r ther related manuals, cntact CME Ltd. Head Office. The infrmatin in this dcument has been carefully cmpiled, and is believed t be entirely reliable. Hwever, n respnsibility is assumed fr inaccuracies. Furthermre, CME Ltd. reserves the right t make changes t any prducts herein t imprve readability, functin, r design. CME Ltd. des nt assume any liability arising ut f the applicatin r use f any prduct described herein; neither des it cver any license under its patent rights nr the rights f thers. 1.2 Abut this manual The peratr must be thrughly familiar with the T34 ambulatry syringe pump described in this manual prir t use, and in particular must read and understand any warnings and precautins stated herein. If a sftware change ccurs and the peratin/specificatin fr the pump changes, new r additinal perating instructins will be issued, if needed. All illustratins used in this manual shw typical settings and values that may be used in setting up the functins f the pump. These settings and values are fr illustrative use nly. The cmplete range f settings and values are listed in the specificatins sectin f this manual. This peratin manual dcument has been develped with cnsideratin t the requirements in relevant Harmnised Standards. Data presented in the technical specificatins reflect specific test cnditins defined in this standard. Other external factrs such as varying back pressure, temperature, head height, set usage, fluid restrictins, slutin viscsity r cmbinatins f these factrs, may result in deviatins frm the perfrmance data enclsed. 1.3 Advisry terms and perating precautins and warnings Warnings, precautins and ntes Warnings and ntes will be seen thrughut this manual. These are described as: NOTE: Indicate that the infrmatin that fllws is additinal imprtant infrmatin, a tip that will help yu recver frm an errr r pint yu t related infrmatin within the manual. PRECAUTION: Indicates that the infrmatin is a precautin. Precautins advise yu f circumstances that culd result in damage t the device. Read and understand this manual and all precautins cmpletely befre perating T34 ambulatry syringe pump. WARNING: Warnings advise f circumstances that culd result in injury r death t the user/peratr r circumstances that culd result in damage t the device. Read and understand this manual and all warnings befre perating the T34 syringe pump. Sftware Versin NCAT / NCATBOL 3

4 Operating precautins and warnings This device cmplies with Part 15 f the FCC Rules. Operatin is subject t the fllwing tw cnditins: (1) this device may nt cause harmful interference (2) this device must accept any interference received, including interference that may cause undesired peratin. Althugh the T34 syringe pump has been designed and manufactured t exact specificatins, it is nt intended t replace trained persnnel in the supervisin f infusins. CME Ltd. will assume n respnsibility fr incidents which may ccur if the prduct is nt used, stred r transprted in accrdance with the envirnmental cnditins stipulated in this dcument r n the package labelling. This syringe pump is designed fr ambulatry use and shuld withstand everyday handling. If the pump is drpped nt a hard surface, r is suspected f being drpped, the peratin and calibratin shuld be checked by a qualified technician. The specified accuracy f the pump can nly be maintained if the pump is used, maintained and serviced in accrdance with the instructins given in this manual. If the pump has failed t calibrate during the servicing prcedure, it must be returned fr repair r dispsal. Adjustments, maintenance, r repair made by un-certified service persnnel may impair the peratin f the pump and/r the accuracy f the infusin. Make sure any adjustments, maintenance, r repair f the device are carried ut nly by authrised and skilled technicians. Refer all service, repair and adjustments nly t qualified and certified technical persnnel. Unauthrised mdificatins r the use f any spare parts, ther than thse supplied by the manufacturer r their distributr, will vid any warranty. If the pump is drpped, subjected t excessive misture, humidity r high temperature, r therwise suspected t have been damaged, remve it frm service fr inspectin by qualified persnnel. The pump has been designed t be as safe as pssible t handle; hwever, care shuld be exercised t avid trapping f fingers r ther bdy parts in the mechanism. The T34 syringe pump system shuld be perated within a temperature range f -15 C (-59 F) t +45 C (+113 F). Operatin at temperatures utside this range may affect accuracy. Infusin precautins and warnings Carefully read and fllw accmpanying set instructins fr priming the set and the recmmended set change interval. The syringe and administratin set shuld be dispsed f in an apprpriate manner, cnsidering the nature f the residual fluid that may be cntained within and in accrdance with the hspital/hmecare prvider s dispsal practices. Drugs fr infusin t be used with the pump may nly be prescribed by a qualified medical practitiner. Cautin must be exercised in the selectin f drugs and the amunt and rate intended t be delivered via any infusin pump. If the drug cntained in the syringe will be expsed t extreme envirnmental cnditins fr prlnged time perids, it is imprtant t select drugs that will nt change pharmaclgically upn such expsure. As with all autmatic infusin devices, whenever a txic r dangerus level f drug is stred in the reservir, cnstant/frequent mnitring f the infusin is required. In all applicatins, time t alarm under cclusin r ther fault cnditins will depend n the infusin rate and levels f alarm settings. It is recmmended t cnsider these parameters when using drugs requiring infusin stability r lw flw rates and therefre a quick time t alarm. Sftware Versin NCAT / NCATBOL 4

5 General precautins and warnings The T34 syringe pump must always be used in a CME Ltd puch r similar receptacle if used in direct sunlight. If the pump is expsed t direct sunlight, it may affect functinality. D nt use hard r sharp bjects n the keypad. D nt bath r shwer whilst using the pump. The pump is resistant t a limited amunt f splashing, but its cnstructin des nt make it resistant t large amunts f spraying r immersin in liquids. Damage t the internal cmpnents may result. If the pump is drpped, subjected t excessive misture, humidity r high temperature, r therwise suspected t have been damaged, remve it frm service fr inspectin by qualified persnnel. D nt perate the pump near high-energy radi-frequency emitting equipment, such as electr-surgical cauterising equipment as this may result in false alarm signals r errr messages being displayed. 1.4 Intended use The T34 syringe pump is designed fr infusin f medicatins r fluids requiring cntinuus r intermittent delivery at precisely cntrlled infusin rates thrugh all clinically acceptable rutes f administratin including intravenus, subcutaneus, percutaneus, epidural in clse prximity t nerves, and int an intraperative site (sft tissue/bdy cavity/surgical wund site). The system is intended fr patients wh require maintenance medicatins, analgesics, chemtherapeutic agents and general fluids therapy in hspital and hmecare envirnments. 1.5 Cntraindicatins Infusin f bld and bld prducts Infusin f insulin Infusin f critical medicatins whse stppage r interruptin culd cause serius injury r death Use in ambulatry regimens by patients wh d nt pssess the mental, physical r emtinal capability t self-administer their therapy; r wh are nt under the care f a respnsible individual Sftware Versin NCAT / NCATBOL 5

6 1.6 System symbls The fllwing symbls are used n the T34 syringe pump and cmpnents. Labels n the pump r statements in this manual preceded by any f the fllwing wrds and/r symbls are f special significance and/r are intended t help yu t perate the pump in a safe and successful manner. System symbl identificatin and descriptin Symbls Pump Descriptin Attentin, cnsult the accmpanying instructins. Attentin, refer t perating instructins. CSA mark. CE mark indicates cnfrmance t Medical Device Directive 93/42/EEC. IPX3 Symbl fr degree f prtectin against ingress f water. D nt dispse f battery in municipal waste. Symbl indicates separate cllectin fr battery is required. Type CF applied part. Date f manufacture. Manufacturer. SN Serial number. Dispsables The use f single-use dispsable cmpnents n mre than ne patient is a bilgical hazard. D nt reuse single-use dispsable cmpnents. Expiry date (cnsumables). LOT STERILE EO Lt number (cnsumables). Sterilized with Ethylene Oxide. Sftware Versin NCAT / NCATBOL 6

7 1.7 Syringe pump specificatins Type: Flw Rate: Actuatr Travel: Syringe Sizes: Accuracy: Occlusin Pressure: Battery: Battery Operatin: Indicatrs: Alarms: T34 Dimensins: Classificatin: Husing: Weight: Electrical Safety: Standards: EMC: Envirnmental Specificatins: T34 syringe pump specificatins Syringe Pump with mtr driven linear actuatr, pulsed mtin (540 pulses per mm) mL/h in 0.01mL increments, 10 t 650mL/h in 1 ml increments (1000 ml/hr available). c.67 mm available. 2 ml t 50 ml (mst cmmnly used manufacturers). ± 5 % system accuracy (pump and set cmbined) mmHg cnfigurable (10mmHG increments). Max. actuatr frce 50N (5 Kgf). 9V alkaline, IEC 6LR61 type (r Lithium fr extended life). 7 full deliveries depending n infusin and set up parameters. 4 Line LCD display (122 x 32 pixels), Dual clr peratin LED When a prblem is detected, the T34 displays the fllwing alarm messages, sunds an audible alarm and the LED lights red: Occlusin r Syringe Empty End Prgram End Battery 169 x 53 x 23mm. Pump Paused T Lng Syringe Displaced Syringe Empty Type CF Equipment, degree f prtectin against electrical shck, IPX3 prtectin against ingress f water. ABS (fire retardant). 210 gr. Withut battery. Cmplies with IEC (Medical Electrical Equipment Safety), IEC (Infusin pumps and cntrllers), IEC (Prgrammable Electrical Medical Systems). Manufactured in accrdance t ISO 9001:2008 and ISO 13485:2003. CE marked in accrdance with the Medical Devices Directive 93/42/EEC. CME Ltd. T34 syringe pump is designed t be in cmpliance with EN (Safety) and IEC (EMC). Nn-Operating Cnditins (Transprtatin and Strage): Temperature: -25 C t 55 C (-13 F t +131 F) Humidity: 5 % t 100% R.H., nn-cndensing Air pressure: 48kPa t 110kPa Operating Cnditins: The system may nt meet all perfrmance specificatins if perated utside f the fllwing cnditins: Temperature: +15 C t +45 C (+59 F t +113 Humidity: 20 % t 85% R.H. at +40 C, nn-cndensing Air pressure: 70kPa t 110kPa Sftware Versin NCAT / NCATBOL 7

8 1.8 Limited Warranty The T34 syringe pump has been carefully manufactured frm the highest quality cmpnents. Caesarea Medical Electrnics Ltd. (CME) guarantees the pump against defects in material and wrkmanship fr twelve (12) mnths frm date f purchase. CME s bligatin, r that f its designated representative under this Limited Warranty, shall be limited, at CME s ptin, r that f its designated representative, t repairing r replacing pumps, which upn examinatin, are fund t be defective in material r wrkmanship. The repair r replacement f any prduct under this Limited Warranty shall nt extend the abvementined Warranty perid. All repairs under this Limited Warranty shuld be undertaken nly by qualified, trained service persnnel. In the event that a pump is fund t be defective during the warranty perid, the purchaser shall ntify CME r its designated representative within thirty (30) days after such defect is discvered. The defective pump shuld be sent immediately t CME r its designated representative fr inspectin, repair r replacement. Shipping csts are the purchaser s respnsibility. Material returned t CME r its designated representative shuld be prperly packaged using CME shipping cartns and inserts. Inadequate packaging may result in damage t the pump. This Limited Warranty shall nt apply t defects r damage caused, whlly r in part, by negligence, spilt fluids, drpping f the pump, misuse, abuse, imprper installatin r alteratin by anyne ther than qualified, trained persnnel; r t damage resulting frm inadequate packaging in shipping the pump t CME r its designated representative. If, after inspectin, CME r its designated representative is unable t identify a prblem, CME r its designated representative reserves the right t invice purchaser fr said inspectin. This Limited Warranty is the sle and entire warranty pertaining t CME s prducts and is in lieu f and excludes all ther warranties f any nature whatsever, whether stated, r implied r arising by peratin f law, trade, usage r curse f dealing, including but nt limited t, warranties f merchantability and warranties f fitness fr a particular purpse. Purchaser expressly agrees that the remedies granted t it under this limited warranty are purchaser s sle and exclusive remedies with respect t any claim f purchaser arising under this Limited Warranty. Managing Directr Caesarea Medical Electrnics Ltd Sftware Versin NCAT / NCATBOL 8

9 1.9 Pump inspectin and unpacking Inspecting the pump befre use Remve the T34 syringe pump and accessries frm the packaging and inspect fr damage during shipment r strage. Make sure yu have the fllwing items: T34 syringe pump Operatins Manual (hard/electrnic cpy) If any items are missing r damaged, cntact yur supplies department. WARNING: Visually inspect packaging and cntents befre each use. WARNING: D nt use the T34 syringe pump and accessries if there are any bvius signs f damage. Return fr inspectin by authrised service persnnel. Accessries (if purchased) Alkaline 9V batteries Lckbx (supplied with tw keys) Carry Puch (re-usable r dispsable) If any items are missing r damaged, cntact yur supplies department. WARNING: Only use accessries designed fr the system. Unsafe peratin may result frm using imprper accessries. Use nly accessries and ptins designed fr this system and supplied r recmmended by the T34 syringe pump distributr. Sftware Versin NCAT / NCATBOL 9

10 SECTION 2: DISPOSABLES AND ACCESSORIES 2.1 Syringe brands and sizes The T34 syringe pump is prgrammed t recgnize mst cmmnly used syringes frm 2 ml t 50 ml. Luer lck syringes shuld always be used t ensure secure cnnectin f the infusin set and syringe. Fr hmecare applicatins it is recmmended that all but the brand f syringe in regular use are disabled per the technician menu t prevent accidental selectin f the incrrect brand during set up. WARNING: DO NOT USE Slip-tip syringes. Luer Lck syringes must always be used t ensure secure cnnectin f the infusin set and the pump is calibrated t Luer Lck. Failure t d s may result in under r ver infusin as the dimensin f sme manufacturers slip-tip syringes differ frm their wn Luer Lck variants. It is recmmended that all but the brand f syringe in regular use are disabled via the BdyCmm Cmmunicatin Sftware t prevent accidental selectin f the incrrect brand during set up. Shuld the need arise t prgram the T34 syringe pump t perate with a manufacturer and/r brand ther than ne f thse listed abve yu shuld cnsult either yur lcal medical engineering department r CME Ltd. Technical Services. Default syringe brands cnfigured fr use Braun Omnifix 2, 5, 10, 20, 30 & 50mL BD Plastipak 3, 5,10, 20, 30l & 50mL Mnject 6, 12, 20, 35 & 50mL Cdan/Once 2.5, 5, 10, 20, 30 & 50mL Terum 5, 10, 20, 30 & 50mL It is pssible t disable default syringes frm the memry r replace them with ne nt listed abve. This prcedure is nt detailed in this manual as it shuld nly be undertaken by trained, certified service centres r bimedical engineers. Please cnsult a bimed engineer r yur lcal T34 syringe pump distributr shuld this need arise. Syringe vlumes Due t the physical length f the screw that drives the syringe plunger frward there are limits t the maximum amunt that can be delivered frm larger syringes and n sme smaller syringes there is an undeliverable vlume that will be left in the syringe nce the actuatr has driven t the zer psitin. NOTE: Braun 2mL, Cdan 2.5mL and Mnject 6mL syringes exhibit a slight undeliverable vlume f 0.1mL due t their design. The T34 will display the vlume as VOLUME 2.4 (f 2.5mL). In this example the pump can nly deliver 2.4 f the 2.5mL in the syringe and when the pump has driven as far frward as pssible 0.1mL will be left in the syringe. WARNING: Sme manufacturers have several brand names within their ranges (e.g. Braun Omnifix and Braun Perfusr). Only use the brands named abve with the T34 as failing t d s culd result in an under r ver infusin. Sftware Versin NCAT / NCATBOL 10

11 Maximum fill vlume fr syringes 20mL t 50/60mL Syringe brand Syringe size 20mL 30mL 50/60mL Mnject 18.7mL mL Braun Omnifix 20mL 24.4mL 37.7mL BD Plastipak 18mL 23.5mL 34.9mL Terum 18.6mL 24.5mL 38.0mL Cdan 20mL 22.5mL 35.9mL Time t alarm frm cclusin The cclusin times t alarm fr the T34 syringe pump are in accrdance t the table belw. All the tests were perfrmed using a CME extensin set, S and a BD Plastipak syringes filled with water. Time t alarm frm cclusin Manufacturer Size Rate 300mmHg 600mmHg 900mmHg BD Plastipak 5ml 10ml 20ml 50/60ml 1ml/h 11' 11'50" 14'30" 100ml/h 7" 10" 10" 1ml/h 17'30" 20'25" 31'30" 100ml/h 8" 11" 13" 1ml/h 29'30" 42'30" 58'45" 100ml/h 19" 20" 23" 1ml/h 46' 54'30" 117' 100ml/h 28" 34" 36" The tlerance fr the BD Plastipak 50/60mll syringe is ±25% r ± 100mmHg The tlerance f the BD Plastipak 5ml syringe is ±25% ±200mmHg 2.2 Administratin sets Intrductin The T34 syringe pump can be perated with any extensin set with a Luer cnnectin. Hwever, it is recmmended, t ptimise system accuracy and perfrmance, that prprietary sets frm CME Ltd. are used. All CME Ltd. sets have siphn/free flw prtectin. Sftware Versin NCAT / NCATBOL 11

12 Features and characteristics Feature Materials Tubing Slide Clamp Check valve (ne-way valve) Descriptin The administratin sets are manufactured using PVC materials that d nt cntain latex r Di (2-ethylhexyl) phthalate (DEHP). Micr-bre: require small priming vlumes. Anti-kink: t prevent kinking r cclusin particularly in ambulatry cnfiguratin. Varius lengths available. Clamps: t prevent fluid flw t patient (ptinal n sme sets). All CME Ltd. syringe extensin sets cntain a cmbinatin check valve t prevent uncntrlled flw f fluid either twards r frm the patient. The syringe extensin set with pressure activated anti-siphn/anti-reflux valve reduces the ptential fr gravity flw and backflw (backtracking). The pressure-activated anti-siphn valve requires pressure t pen. The pump cclusin pressure setting may require adjustment t prevent cclusin alarms. Luer Lck end cnnectr Clr-cded sets The cmbinatin check valve enhances pump functining by: Preventing siphning (free-flw) in the event the set is detached frm the pump r mechanical malfunctin Preventing reflux (back-flw) in the event several infusin pumps are cnnected simultaneusly t the same patient. The administratin set is designed t be cnnected t Luer Lck syringes. Luer Lck syringe allws a needle t be twisted nt the tip and then lcked in place. This prvides a secure cnnectin and prevents accidental remval. Clr cded sets are available as a visual aid t assist users in identifying a drug delivery rute: Clear sets may be used fr any drug delivery rute Blue sets nrmally indicate intravenus drug delivery rute Yellw sets indicate epidural r intrathecal drug delivery rute WARNING: Ensure the administratin set is NOT cnnected t the patient during priming. WARNING: A kinked/ccluded infusin line may impair the peratin and accuracy f the pump. Befre peratin, verify that the infusin line is nt kinked r ccluded. NOTE: Manufacturing data fr set durability and accuracy f prprietary sets is up t 72 hurs. Fllw lcal guidelines fr set use. Advisry warnings and ntes fr syringes and administratin sets: WARNING: Never prime r purge a set with the extensin set attached t the patient. WARNING: Cmpnent damage may ccur if the set is nt crrectly attached t the syringe. Assure all cnnectins are secure: DO NOT ver-tighten. This will help minimise leaks, discnnectin and cmpnent damage. WARNING: Dispsables (as with any infusin) used with the syringe pump must be cmpatible with the drug/fluid being delivered. Check with the manufacturer f the dispsables befre use. Cnsult the fluid r drug manufacturer s infrmatin fr precautins, guidelines, and instructins fr preparatin and use f dispsables. Sftware Versin NCAT / NCATBOL 12

13 WARNING: Replace the syringe and/r set in accrdance with lcal guidelines. WARNING: Use gd aseptic technique when filling the syringe and priming the administratin set. Patient infectin may result frm the use f nn-sterile cmpnents. Maintain sterility f all dispsable cmpnents and d nt re-use singe use sets. WARNING: Syringes and administratin sets shuld be dispsed f in an apprpriate manner, cnsidering the nature f the residual fluid that may be cntained within, in accrdance with the hspital/hmecare prvider s dispsal practices. 2.3 Battery pwer supply Battery types and use Always use a 9-vlt alkaline dispsable battery. CME Ltd. recmmends t always use a battery carrying the internatinal marking cde 6LR61. WARNING: Unsafe peratin may result frm using imprper accessries. Use nly accessries and ptins designed fr this system and supplied r recmmended by the T34 syringe pump distributr. Batteries marked 6LP3 are nt recmmended fr use with the T34 syringe pump. 6LP3 batteries can cause issues with the peratin f the syringe driver, as the physical cnstructin, and internal resistance f this type f battery, are different t the 6LR61 battery. Issues arising frm use f the 6LP3 battery can include End Battery messages during Pre-Lad, vlume test fails, pressure test/calibratin issues and reduced amunt f infusins frm a battery. WARNING: There is sme variatin in size between different brands f batteries. Never try t frce a battery int the battery cmpartment as this may damage the battery cntacts. Incrrectly aligning the battery cntacts will nt cause any harm t the battery r the pump. Remve the battery and re-align the cntacts. Battery dimensins and battery fitting Dispsable battery dimensins can vary between different brands f batteries (either larger r smaller than the standard size). Sme brands f battery will nt fit int the battery cmpartment area as the dimensins are t large and ther battery brands may be smaller and appear lse in the battery area, which can result in mvement within the battery husing with pssible lss f cnnectin/pwer. If a battery is t large t fit, use a different battery brand. If a battery within the T34 husing appears lse careful adjustment f the battery cnnectins may be needed t mve them back t the crrect psitin. Return the pump t yur service department fr adjustment f the cnnectins. Battery cmpartment cnnectrs in crrect psitin Sftware Versin NCAT / NCATBOL 13

14 Battery life Factrs that affect battery life include: Pump settings Infusin rate The number f interventins that ccur (e.g. stpping/starting infusins, manual mvement f actuatr and backlight activatin) The number f key presses that ccur Frequency f LED green light flashing Battery chemical and cnstructive cmpsitins The pump battery meter displays battery life remaining as a percentage (%) When the battery pwer is lw a lw battery alert will activate When the battery pwer is almst depleted, an end f battery alarm will activate The end f battery alarm will cntinue until the user presses YES t cnfirm r the battery pwer if fully depleted. Refer t alerts, alarms and trubleshting sectin fr further infrmatin. Indicatins t change a battery Average battery life is apprximately three t five days. Based n five days f nrmal pump use, fr a battery with 100% pwer, battery pwer cnsumptin wuld average 20% per day. Guidance fr battery changing may vary fr different areas accrding t lcal plicy and where the pump is t be used and wh is managing the pump (healthcare prfessinal r patient as end user). If the pump is being managed in an envirnment where designated persnnel are available at all times t change a battery if necessary, the lw battery alert can be used as an indicatin t change a battery. If the pump is being managed in an envirnment where designated persnnel are unavailable t change a battery if necessary, the fllwing rule applies: T ensure delivery f a 24-hur infusin, ensure that there is a minimum percentage available at the start f the infusin. Battery fitting and remval Inserting and remving a battery The battery shuld fit securely t prevent lss f battery t pump electrde cntact. WARNING: DO NOT use scissrs r metal bjects t remve a battery. T insert the battery int the pump: 1. Slide the cmpartment cver ff at the back f the pump. 2. Push the battery int the cmpartment taking care t ensure that the battery + / - cntacts are aligned n the label inside the cmpartment. 3. Slide the cver back n. Sftware Versin NCAT / NCATBOL 14

15 T remve the battery frm the pump: a. Slide the cmpartment cver ff at the back f the pump. b. Remve the battery c. Slide the cver back n. 2.4 Lckbx Uses and features Lckbxes are designed t help prtect the syringe frm displacement and/r tampering. Lck bxes are made frm Plycarbnate due t its high impact, temperature resistance and ptical prperties, durability tests cnfirm that the verall design and cnstructin f the T34 syringe pump lck bx ensures that they are fit fr their intended purpse f prtecting the T34 syringe pump frm damage caused thrugh nrmal daily use and drps within the accepted nrmal range f ne meter. Types and sizes Lckbx fr cmmnly used syringes up t 30mL Lckbx fr cmmnly used syringes up t 50/60mL Lckbxes are available in clear plycarbnate and with a yellw transparent tinge. A clear lckbx can be used with any drug delivery rute A yellw tinged lckbx dentes epidural r intrathecal drug delivery rute NOTE: lckbxes are designed fr the use with CME Ltd. administratin sets. If using an alternate brand f administratin set with a cmmnly used 30mL syringe the set design may prevent the lckbx frm fully clsing and lcking. Refer t yur lcal sales representative r CME Ltd. website fr infrmatin n lckbx types, cdes and csts. Using the lckbx When ready, place the pump int the lckbx +/- carry puch: 1) Open the lckbx using the standard key that perates all T34 lckbxes. 2) Place the pump int the lckbx s that the LCD display and keypad line up with the cut ut pening. 3) Clse the lckbx, guiding the administratin set ut f the slt at the side f the tp sectin f the bx. 4) Place the lckbx (r syringe pump if the security f the lckbx is nt required fr yur practice) int the carry puch and secure t the patient. Sftware Versin NCAT / NCATBOL 15

16 2.5 Carry Puches Puch use and types Dispsable (single patient use) and re-useable (washable) puches are available. Refer t yur lcal sales representative r CME Ltd. website fr infrmatin n types, cdes and csts. Refer t Sectin 7 fr re-usable puch cleaning instructins. Use f puches fr prtectin f pumps during transprtatin WARNING: The T34 syringe pump must always be used in a CME Ltd puch r similar receptacle if used in direct sunlight. If the pump is expsed t direct sunlight, it may affect functinality. Using the pump with a CME Ltd. puch r similar receptacle during transprtatin r patient ambulatin whilst the pump is infusing prtects the pump functinality and the medicatin in the syringe frm expsure t direct sunlight. The puch will als prtect the pump frm damage r syringe displacement. When using the CME Ltd re-useable (washable) puch, it is pssible t access the screen and keypad f the device during infusin by lifting the velcr flap f the puch whilst the pump remains in the puch. When using either a CME Ltd re-useable (washable) r dispsable (single patient use) puch it is pssible t remve the frward part f the device during infusin frm the puch t inspect the syringe withut remving the rear sectin f the device. CME Ltd puches can be carried n the shulder r arund the waist fr cnvenience. Sftware Versin NCAT / NCATBOL 16

17 SECTION 3: PUMP FEATURES AND DESCRIPTION 3.1 Overview The T34 syringe pump is a small, lightweight, rbust, battery pwered infusin pump. It is equally suitable fr adults r paediatric use. The T34 syringe pump may be used fr a variety f clinical applicatins t deliver indicated medicatins via cmmn infusin rutes, including intravenus and subcutaneus. Safety features Accmmdates a range f cmmnly used syringe brand and sizes Three-pint syringe detectin system Access cde prtected areas fr pump cnfiguratin Lckable infusin prgram Capable f small ml/hur rate delivery Pst Occlusin Blus Reductin System Cnfigurable cclusin pressure setting LCD display screen with backlight Green LED indicatr light t indicate if infusin is in prgress Cmprehensive range f alerts and alarms Keypad lck Event Lg Lckable lckbx 3.2 Pump descriptin Tp f pump: syringe fitting N. Area Functin 1. Barrel clamp arm sensr Detects syringe barrel lading and secures syringe in place 2. Cllar sensr Detects crrect lading f the syringe cllar 3. Plunger sensr Detects crrect lading f the syringe plunger 4. Lead screw Mves actuatr 5. Actuatr Drives the syringe plunger t deliver syringe cntents 6. Guide rails The tw guide rails supprt the actuatr psitin Sftware Versin NCAT / NCATBOL 17

18 Frnt f pump: keys and display screen N. Area Functin 1. INFO key a) repeated presses during infusin will display infusin summary and battery level b) when pump paused, accesses the main (Inf) menu c) activates/deactivates keypad lck 2. UP arrw key a) scrlls between ptins b) increases infusin parameters during prgramming/titratin 3. DOWN arrw key a) scrlls between ptins b) decreases infusin parameters during prgramming/titratin 4. YES/START key a) Cnfirms selectin b) Starts infusin 5. NO/STOP key a) stps infusin b) takes user back a step during prgramming 6. FF (Frward key a) mves actuatr frward when n syringe in place and the barrel clamp arm is dwn b) accesses purge functin (if enabled) 7. BACK (Reverse) key Mves actuatr backward when n syringe is in place and barrel clamp arm is dwn 8. ON/OFF key Pwers the pump n and ff 9. LED light A green indicatr lights: (a) during system self-test (b) intermittently t indicate infusin delivery A red indicatr lights: (a) cntinuusly t indicate an alarm state (b) when pump paused/n stand-by mde 10. LCD display screen Displays pump and infusin status, prgramming chices and instructins Sftware Versin NCAT / NCATBOL 18

19 Back f pump: battery area and pump markings N. Area Functin 1. Pump infrmatin and symbls Labelling (including universal symbls) identify a device, its manufacturer, and cmmunicates infrmatin n safety, use and perfrmance. 2. Battery fitting area Includes instructins fr inserting the battery int the crrect psitin. 3. Dcking statin cmmunicatin cnnectr When the pump is placed int a dcking statin, prvides cnnectin t PC/ BdyCmm Cmmunicatin Sftware 3.5 Event Lg What is the event lg? The event lg shws a cmplete time and date stamped recrd f the last 512 pump events alng with a recrd f pump status (vlume infused, rate, etc.) at the time f the event. Event lg data cannt be deleted r altered and it is nt patient specific i.e. the 512 events are likely t span multiple patients treated with that particular pump. Each event is assigned a new number and the pump stres the last 512 in memry. Fr event s ver 512, the pump deletes the ldest event in the lg each time a new event ccurs. Fr example, after sme time, the first event t appear when yu enter the events histry may be number 754. This means there have been 754 events in this pumps life and events are stred in this histry. The pump deletes the ldest event in the lg each time a new event ccurs. Events recrded include hurly self-testing when an infusin is running and certain key presses. When the pump is infusing, the pump will recrd pump status every hur irrespective f any key presses. The event lg can be viewed via the pump r BdyCmm Cmmunicatin Sftware and a print ut f events can be btained using BdyCmm Cmmunicatin Sftware. Event Lg access and navigatin The event lg cannt be accessed whilst an infusin is running, if necessary, stp the infusin and remve keypad lck. Press the INFO key: Inf Menu Battery Level Select /, Press YES 2. Use / keys t scrll t Event Lg Inf Menu Event Lg Select /, Press YES 3. Press YES The mst recent event displays: Sftware Versin NCAT / NCATBOL 19

20 Event N: :01 Start Infusin Press INFO - Details Line 1: Event Number Line 2: Date and time f event Line 3: Event descriptin/perating state Line 4: View details n this event Either use / keys t scrll up/dwn thrugh events r, Press INFO t display detailed data fr the event. When INFO is pressed: VI 1.03ml VI = Vlume infused VTBI 14.35ml VTBI = Vlume t be infused Rate 0.64ml/h Rate = ml/hur rate 30mL BD Plastipak = Syringe brand and size cnfirmed 30ml BD Plastipak Travel 2.73mm/ml Travel = Actuatr travel distance (mm) t deliver 1mL (fr syringe size/brand cnfirmed) 1N = Minimum actuatr travel frce (related t start up mtr mvement) 1N (0mmHg) = 18mA 28 = Maximum actuatr travel frce (related t start up mtr mvement) 28N (540mmHg)=83mA Mtr current = mtr current level in ma Mtr Current 0 ma Occlusin = Pump cclusin alarm setting Occlusin 720mmHg Battery = Battery vltage Battery 7.8V Either use / keys t display further infrmatin r t return t the previus screen, press NO. The event infrmatin that displays when INFO is pressed will vary depending n the peratinal status f the pump fr that event. Sme events may nly recrd ne r tw parameters, ther events recrd numerus parameters. NOTE: The pump des nt autmatically change fr daylight saving, the date and time can be updated manually via the pump Change Set Up Menu r via the BdyCmm Cmmunicatin Sftware. Event Lg examples Switched ON Syringe Remved Anti-blus Reverse Keypad Lck ON Switched OFF Occlusin / End Stp Infusin Keypad Lck OFF Vlume Change Purge Pump Operating System Errr NOTE: Other events may be recrded relating t technical infrmatin, refer t the technical service Manual. 3.6 Pst Occlusin Blus Reductin System (POBRS) What is the Pst Occlusin Blus Reductin system? During an cclusin, the pressure in the dwnstream sectin f the line and/r inside the syringe can increase abve the cclusin pressure defined in pump settings. When the pump alarms the user must check the line and attempt t clear the cclusin. During an cclusin the pump s Pst Occlusin Blus Reductin System feature will reverse the peratin f the mtr and drive the actuatr backwards therwise the pressure build up culd cause a surge f fluid int the patient n release f the cclusin. When the infusin is resumed, the user will ntice that the vlume t be infused (VTBI) increases and the vlume infused (VI) decreases t indicate the pump back ff feature and the infusin time remaining increases; this prtects the ml/hur infusin rate. Fllwing activatin f the POBRS and if the user presses YES t Resume the infusin VTBI increases and the VI decreases t indicate the pump back ff feature. Occlusin pressure The cclusin pressure f a pump is the pressure in the system, registered at the pump, when the pump is still Sftware Versin NCAT / NCATBOL 20

21 perating but cannt sustain the flw rate. The resultant build-up f pressure sets ff the cclusin alarm. (Device Bulletin, 2010). Occlusin and respnse An cclusin alarm can be activated by: A blckage in the delivery tubing - ften inadvertently caused by kinking r leaving a rller clamp r a tap clsed. A cltted-ff cannula. A partially ccluded cannula - if it causes the required driving pressure t rise abve the cclusin alarm level. A very lng r narrw bre cannula r/with extensin line. Occlusin respnse is characterised in terms f three measurable parameters: 1. Pressure t alarm 2. Time t alarm 3. Blus release when cclusin is reslved 1. Pressure t alarm If an cclusin ccurs the pump attempts t maintain sufficient pressure n the fluid t cause it t flw thrugh all restrictins and vercme any additinal resistance. Althugh fluid is incmpressible, the administratin set and ther cmpnents f the system have sme give (cmpliance) and the tubing can expand under the increasing pressure. Other cmpnents f the system, such as the bung f the syringe, becme cmpressed. This expansin and cmpressin takes sme time t ccur. 2. Time t alarm If the cclusin is present frm the beginning f the infusin, the time t alarm will increase. The pressure in the pumping chamber increases frm zer at the start f the infusin up t the alarm level. This is the mst likely situatin, as leaving clamps clsed is the mst usual cause f cclusins. If the cclusin ccurs after the pump has stabilised at its set flw rate, the alarm time will nt be unusually lng as the pressure in the pumping chamber increases frm the already high running pressure up t the alarm level. Fr example, a time t alarm with an infusin rate f 1mL/h is 16 minutes 7 secnds (PASA, 2006) Generally, shrter time t cclusin alarm ccur with high flw rates, small syringes and gd quality syringes. 3. Blus release In the case f a cmplete cclusin, there is n flw t the patient whilst pressure in the system is increasing. When the cclusin is released, the build-up f fluid in the tubing can result in a blus being delivered t the patient. Sftware Versin NCAT / NCATBOL 21

22 SECTION 4: MODES OF OPERATION 4.1 Mdes f peratin Intrductin This sectin prvides describes the cmmn infusin mde f peratin in which the T34 can be cnfigured t perate. The pump can be cnfigured fr a cntinuus infusin with either duratin r ml/hur as the primary setting. Duratin infusin The primary setting is duratin (vlume ver time infusin) which can be cnfigured with a lcked r changeable duratin time. Once the duratin time is cnfirmed, the pump will calculate the ml/hur rate. Rate infusin (ml/hur) The primary setting is ml/hur rate (rate ver time infusin) which can be cnfigured with a lcked r changeable ml/hur infusin rate. Once the ml/hur rate is cnfirmed, the pump will calculate the duratin time. Cmmn pump cnfiguratins Fur cmmn pump cnfiguratins are: Lck On mde - fixed duratin Lck Off mde - adjustable duratin Rate mde (Lck ON) - fixed ml/hur rate Rate mde (Lck OFF) - adjustable ml/hur rate Each f these mdes can have additinal functins enabled r disabled, t suit lcal requirements. The pump default mde f peratin is Lck On 24-hur duratin. WARNING: Fr the crrect pump cnfiguratin, mde f peratin and start up sequence, yu must refer t yur lcal plicy. Lck n mde (fixed duratin) The pump will deliver the syringe vlume ver the fixed (lcked) duratin. Once a syringe is detected and cnfirmed, the pump calculates the ml/hur infusin rate: Syringe vlume Fixed duratin = ml/hur infusin rate With the Prgram Lck On, rate change (titratin) during infusin cannt be enabled. KVO and purge can be enabled if required. NOTE: During prgramming, the user must check and cnfirm the infusin summary screen. This includes checking the syringe vlume, duratin, and the calculated rate matches the prescriptin and what is required fr that infusin befre it is cmmenced. Lck ff mde (adjustable duratin) The pump will deliver the syringe vlume ver the cnfirmed default duratin r the duratin inputted and cnfirmed by the user during prgramming, the pump then calculates the ml/hr infusin rate: Sftware Versin NCAT / NCATBOL 22

23 Syringe vlume Default r duratin entered = ml/hur infusin rate With Prgram Lck Off, rate change (titratin) during infusin can be enabled if required. There is n availability t re-prgram the infusin duratin during delivery KVO, purge and rate titratin can be enabled if required NOTE: During prgramming, the user must check, change and/r cnfirm infusin infrmatin and prgramming screens. This includes checking that the prgram summary screen (syringe vlume, duratin, and the calculated rate) matches the prescriptin and what is required fr that infusin befre it is cmmenced. Cmparisn f lck n and lck ff (duratin) mdes Lck On (Fixed Duratin) 20ml BD Plastipak Select /, Press YES Vlume 12.0ml Duratin 24:00 Rate 0.50ml/h Cnfirm, Press YES Start Infusin? Lck ff Mde (Adjustable) Duratin) 20ml BD Plastipak Select /, Press YES Occlusin xxx mmhg Max Rate 5ml/h Prgram Lck OFF Battery Status xx% 20ml BD Plastipak Vlume 12 ml Change /, Press YES 20ml BD Plastipak Duratin 24:00 Change /, Press YES 20ml BD Plastipak Rate 0.5 ml/h Cnfirm, Press YES Vlume 12.0ml Duratin 24:00 Rate 0.50ml/h Cnfirm, Press YES Start Infusin? If the default duratin is changed and/r titratin is enabled additinal screen prmpts will display. NOTE: There are tw alternatives methds fr starting an infusin when using a duratin (vlume ver time) mde f peratin: prime and lad r lad and prime methds. The methd chsen relates t the priming vlume f the administratin set. Yur lcal plicy will state which methd t use. Rate mde (lck n) - fixed ml/hur rate The pump will deliver the syringe vlume ver the fixed (lcked) ml/hur rate. Once a syringe is detected and cnfirmed, the pump calculates infusin delivery duratin: Syringe vlume Fixed ml/hur rate = Duratin Sftware Versin NCAT / NCATBOL 23

24 With the Prgram Lck On, rate change (titratin) during infusin cannt be enabled. KVO and purge can be enabled if required. NOTE: During prgramming, the user must check and cnfirm the infusin summary screen. This includes checking the syringe vlume, duratin, and the rate matches the prescriptin and what is required fr that infusin befre it is cmmenced. Rate mde (lck ff) - adjustable ml/hur rate The pump will deliver the syringe vlume ver the ml/hur rate inputted and cnfirmed by the user during prgramming the pump calculates the infusin delivery duratin: Syringe vlume Cnfirmed ml/hur rate = Duratin With Prgram Lck Off, rate change (titratin) during infusin can be enabled if required. KVO, purge and rate titratin can be enabled if required. Rate mde prgramming screens a) If the pump is cnfigured with Rate Setting disabled, the default is 0mL/hur. When a user is prgramming an infusin, the screen will display: 20ml BD Plastipak Rate 0 ml/h Change /, Press YES This example shws the default rate is 0mL/hur, the user enters the rate required. b) If the pump is cnfigured with Rate Setting enabled, the prgrammed rate becmes the default. When a user is prgramming an infusin, the screen will display: 20ml BD Plastipak This example shws the default rate is 2mL/hur, the user can either cnfirm r change Rate 2 ml/h the rate. Change /, Press YES NOTE: During prgramming, the user must check, change and/r cnfirm infusin infrmatin and prgramming screens. This includes checking that the prgram summary screen (syringe vlume, duratin, and the calculated rate) matches the prescriptin and what is required fr that infusin befre it is cmmenced. Sftware Versin NCAT / NCATBOL 24

25 SECTION 5: PUMP CONFIGURATION 5.1 Pump cnfiguratin Cnfiguratin via BdyCmm cmmunicatins sftware and pump A limited number f settings can be cnfigured via the pump in Change Set Up, Rate Setting and Technician menus and fr safety reasns, these areas are access cde prtected. Full pump cnfiguratin can nly be carried ut via the BdyCmm cmmunicatin dcking statin and PC sftware. Pumps must be cnfigured crrectly fr their required applicatin, this includes selecting the apprpriate mde f peratin, the required additinal functins (e.g. purge, rate titratin and KVO) fr the intended applicatin. Hwever, the pump is cnfigured, the user must ensure that the pump is cnfigured crrectly fr the therapy categry it is t be used fr. BdyCmm Cmmunicatin Sftware BdyCmm Cmmunicatin Sftware is a PC based sftware package which enables the technical engineer t prgram pumps via a PC and pump dcking statin. The sftware allws pump set up and syringe data t be laded t files (macrs) and replay these files n t subsequent pumps. BdyCmm als enables the user t dwnlad, save and print the events lg. Use f this prgram can aid the investigatin f clinical incidents and help ensure that all pumps are cnfigured the same way, withut errr. NOTE: Fr a list f settings, defaults and ranges when cnfiguring a pump via the BdyCmm Cmmunicatins Sftware, please refer t BdyCmm Cmmunicatins Sftware user instructins. Cnfiguratin authrisatin Pump cnfiguratin must nly be carried ut by designated and authrised persnnel, yu must check with yur technical department and/r line manager if yu are designated and have the authrity t change the pump cnfiguratin. When cnfiguring a pump, the fllwing must be taken int accunt, t ensure that: The pump is cnfigured and apprpriate fr the therapy grup as defined by the Medicines and Healthcare Regulatin Authrity (MHRA). The pumps are cnfigured fr the required applicatin, e.g. cclusin pressure settings crrect fr drug delivery rute. The mde f peratin (lck n, lck ff and rate mdes) cnfigured is crrect fr the drug prescriptin. e.g. duratin (vlume-ver-time) r a ml/hur infusin. Optinal features and functins that may be required are cnfigured (e.g. Purge, KVO, titratin, pump maximum ml/hur rate) Any prgram/pump changes that are made must be fully dcumented checked with a secnd persn and against a pump setting authrisatin frm which is available frm lcal r CME Ltd. technical service staff. Sftware Versin NCAT / NCATBOL 25

26 5.2 Pump access cdes Access cdes fr pump cnfiguratin The T34 syringe pump has three areas f access cde prtectin t prevent unauthrised changes t set up, cnfiguratin r prgramming. Certain settings and features may be cnfigured and lcked based n patient r clinical need r t cnfigure the pump fr a specific clinical applicatin. N access cde is required t turn the pump n and run an infusin, in nrmal clinical use the pump user will nt see these fields r be prmpted fr access cdes. The Change Set Up and Rate Settings menus are available via the pump INFO menu. The Technician menu cde is nly prvided t fully trained, (by CME Ltd.) and authrised electrical bimedical engineering persnnel. WARNING: D nt attempt t access cde prtected areas if yu are nt trained r authrised t d s. Authrised persnnel shuld nt share cdes with un-authrised persnnel and nly give cde access t the designated persnnel. NOTE: Cdes will nly be prvided by CME Ltd. t designated and authrised clinical r technical staff when they have been trained and certified in their use. N access cdes are cntained in this manual. 5.3 Pump INFO and cnfiguratin menus INFO menu The pump INFO menu enables the user t navigate t varius functins. This includes accessing the pump cnfiguratin settings (Change Set Up and Rate Setting areas). The INFO menu cannt be accessed during an infusin r with the keypad lck activated. With n infusin running, press the INFO key. Use /, keys t scrll up/dwn the menu t select the ptin required, then press YES t view the cntents. INFO menu descriptin Optin Inf Menu Battery Level Select /, Press YES Inf Menu Event Lg Select /, Press YES Inf Menu Rate Setting Select /, Press YES Inf Menu Change Set Up Select /, Press YES Inf Menu Exit Select /, Press YES View battery life percentage (graph) View pump event lg Descriptin Change and cnfigure Rate Setting functin (access cde prtected) Change and cnfigure prgramming functins (access cde prtected) Exits Inf menu Sftware Versin NCAT / NCATBOL 26

27 Change set up menu Cnfigurable parameters in the Change Set Up menu Parameter Default Range Descriptin Exit Exit the Change Set Up menu. Set Time and Date Current date/time Mnth/year Minute/hur Sets a date and time stamp fr the event lg. This des nt autmatically change fr daylight saving. FF Key Operatin 5mm mm Backlight Duratin 5 secnds On - Off (0-254 secnds) Limits the frward mvement f the actuatr when the FF key is pressed with n syringe in place and barrel clamp arm dwn. Limits the screen backlight duratin fllwing key presses. Inf Duratin 5 secnds 1-20 secnds Limits the screen infrmatin duratin which displays when the INFO key is pressed during an infusin. Operatin LED 32 secnds Disable/2/4/ 8/16/32/64 secnds Limits the frequency f green LED intermittent flashing during an infusin. NOTE: Red LED warning light is unaffected. Titratin Optin Disabled Enabled/ Disabled Enables rate change during infusin. Maximum rate is the pump max. ml/h rate. Minimum is 0.05mL/hur. Can nly be enabled if Prgram lck is Off. Default Duratin 24:00 hurs 00:00 (OFF) 99:00 hurs With a default duratin set, the pump runs as a vlume ver time infusin. With default duratin set t 0:00 hur, the pump runs as an mls/hur infusin. Occlusin Pressure 540mmHg mmhg Sets the pressure level at which the cclusin alarm will activate. KVO Rate Operatin 0mL/hur 0 (OFF)- 2.0mL/h Activates Keep Vein Open infusin at end prgram. Prgram Lck ON OFF/ON With lck n, prevents alteratin f default duratin r ml/hur rate. Rate setting menu Cnfigurable parameters in the Rate Setting area. Parameter Default Range Descriptin Rate Setting 0mL 0 ml/hr Pump max ml/hr rate Lcks the ml/hr rate each time a new prgram is cmmenced in Rate Setting Mde. (If required, pump maximum rate is changed via Technician menu). Sftware Versin NCAT / NCATBOL 27

28 5.4 Pump Cnfigurable settings fr mdes f peratin Mde Parameter Titratin Optin Cnfiguratin settings fr lck n and lck ff (duratin) mdes Lck On (Fixed duratin) Disabled Lck Off (Adjustable duratin) Enable if rate change during infusin required Default Duratin e.g. 24:00 hurs e.g. 24:00 hurs Prgram Lck On Off Rate Setting 0mL 0mL Occlusin Pressure KVO Max. Rate Purge Set the pressure fr the drug delivery rute e.g. subcutaneus, IV Set KVO ml/hur if required. Change if required. Pump default 5 ml/hur. Set purge vlume if required. Pump default 0mL. Mde Parameter Titratin Optin Cnfiguratin settings fr rate (ml/hur) mdes Rate Mde (Lck ON) (Fixed ml/hur rate) Disabled Rate Mde (Lck OFF) (Adjustable ml/hur rate) Enable if rate change during infusin required Default Duratin 00:00 hurs 00:00 hurs Prgram Lck On Off Rate Setting 1mL E.g. 2mL/hur Occlusin Pressure KVO Max. Rate Purge Set the pressure fr the drug delivery rute e.g. subcutaneus, IV Set KVO ml/hur if required. Pump default 0mL. Change if required. Pump default 5 ml/hur. Set purge vlume if required. Pump default 0mL. NOTE: A Pump Cnfiguratin Authrisatin frm is available frm CME Ltd. t recrd authrisatin and dcument pump settings. Cntact yur lcal Sales r Clinical representative. NOTE: Pump maximum ml/hur rate and purge vlume are cnfigured via the pump Technician Menu r BdyCmm Cmmunicatins Sftware. If these settings need t be changed, yu must cnsult technical staff. NOTE: The pump uses an indirect methd f pressure detectin. The standard T34 syringe pump cclusin pressure setting fr subcutaneus rute is 720mmHg and fr Intravenus (IV) rute is 540mmHg. Sftware Versin NCAT / NCATBOL 28

29 5.5 Optinal cnfigurable settings KVO (keep vein pen) peratin The T34 can be cnfigured t deliver a KVO infusin t cmmence at the end f the infusin t keep the patients access device patent. With KVO enabled the pump applies the KVO rate set until the syringe is empty. KVO can be cnfigured in the pump Change Set Up Menu r via the BdyCmm Cmmunicatin Sftware. KVO After three/fur beeps the End Prgram alarm stps and the pump switches t the cnfigured KVO infusin rate. Every three/fur minutes three/ fur beeps will be 0.2ml heard t cnfirm the pump is still infusing. When the KVO vlume is delivered the end prgram alarm activates. Purge In rder t eliminate/reduce mechanical slack (visible spaces at the syringe cllar and plunger lading pints) and ensure a faster start up time (time t start delivering the fluid t the patient/reach the prgrammed infusin rate) the user can purge the system. This facility is available (if enabled) nce nly, prir t cmmencing an infusin. The purge facility is disabled by default (0.0mL) and the maximum deliverable is 2.0 ml. The purge functin can be cnfigured via the pump Technician menu r the BdyCmm Cmmunicatin Sftware. The purge functin can be used with any mde f peratin. Purge sequence (all mdes f peratin) 1. Press the FF key when the infusin/prgram summary displays (Lck On Mde) r when the vlume change screen displays (Lck Off and Rate Mdes). Purge? Discnnect patient Press YES t Cnfirm Purge, Hld FF Key Purge 0.00ml 2. Ensure the administratin set is discnnected t the patient, cnfirm by pressing YES 3. Press and hld the FF key until the slack is remved r purge vlume is delivered (a purge vlume will be cnfigured, e.g. O.2mL) Purge Cmpleted 20ml BD Plastipak Select /, Press YES Press YES t Resume, NO fr New Syringe 4. Wait fr the next screen t display 5. If the syringe size/brand displayed matches the ne used, cnfirm by pressing YES (Use +/- keys t select the matching syringe if necessary) 6. Tw ptins are given, t either resume the current prgram r t start a new prgram, and the subsequent display screens will depend n the ptin selected If the user presses YES: The duratin f delivery decreases t accunt fr the purge vlume The purge vlume will display n the vlume infused (VI) infusin summary NOTE: When purge is used with each syringe change and YES t Resume is selected each time causes the infusin duratin at the end f the purge sequence each the time the healthcare prfessinal needs t attend t change a syringe will be earlier each time. If the user presses NO: The pump calculates a new prgram r the user must enter parameters fr a new prgram Sftware Versin NCAT / NCATBOL 29

30 As the purge vlume has been accunted fr befre prgramming, the purge vlume will nt display n the vlume infused (VI) infusin summary NOTE: If purge is nt enabled until the prgram summary screen, the user re-cnfirms syringe size/brand, then the Press YES t Resume, N fr New Syringe screen displays. If YES is pressed the purge vlume is accunted fr and visible n the VTBI/VI screen, in additin, the infusin time remaining is reduced t reflect the vlume used t purge. If NO is pressed the purge vlume is nt visible n the VTBI/VI screen and the infusin time remaining is the default duratin. By pressing YES t Resume ver several syringes/days, the time the healthcare prfessinal needs t attend t change a syringe will be earlier each time. Rate titratin If enabled, yu can titrate (change) cntinuus infusin flw rates during infusin, it is recmmended that the keypad lck is used as an additinal prtectin against accidental rate change during infusin. The maximum ml/hur rate limit will be the pump maximum rate which is cnfigured via the pump Technician menu r via BdyCmm Cmmunicatin Sftware. The minimum rate is a standard 0.05mL/hur. If this setting needs t be changed, yu must cnsult technical staff. Rate change can be enabled in the fllwing mdes f peratin: Lck Off Mde (duratin) Rate Mde (ml/hur) Rate Setting Mde (ml/hur, Lck Off) Rate change cannt be enabled in Lck On mde f peratin. T titrate the ml/hur rate during infusin 1. Deactivate keypad lck Time Remaining 12:00 Rate 1.0 ml/h <<<< Pump Delivering 20ml BD Plastipak Rate 2 ml/h Change /, Press YES Time Remaining 06:00 Rate 2.0 ml/h <<<< Pump Delivering 5. Activate keypad lck 2. With infusin is running, press r key t change the rate. 3. Enter infusin rate required using r key, cnfirm by pressing YES. 4. Check that the rate change cmpleted and is crrect (Nte change t time remaining) 5.6 Practise scenaris fr changing pump cnfiguratin Changing cnfiguratin will affect the peratin/functinality f the T34 syringe pump. Set up parameters shuld nly be changed by clinical r technical staff with user cde access rights nly and the authrity t change pump settings. D nt change any parameters unless yu clearly understand the significance f the parameter and the effect the change will have n the peratin and functinality f the pump. It is advisable that any cnfiguratin changes are carried ut with n syringe in place and barrel clamp arm dwn. Scenari 1: change date and time Scenari: Change date and time frm 4th February 2009, 16:15 t current date/time. (10th December 2011, 12:30 is demnstrated belw) Sftware Versin NCAT / NCATBOL 30

31 1. T pwer n, press ON/OFF key. Wait until Pre-Lading cmpletes and screen prmpt displays: Lad Syringe Inf Menu 3. Scrll t Change 2. Press the INFO key Battery Level Set Up Select, Press YES Inf Menu Enter Set Up Cde 5. Enter access cde, Change Set Up 4. Press YES 0 press YES Select, Press YES Change, Press YES When the arrw is pressed and held dwn the pump will cunt up in single digits t ten, then in tens t ne hundred and then in hundreds thereafter. Scrll t the nearest pint in ten`s and then release the key. Press either the r arrw individually, until the crrect cde displays then press YES t cnfirm. Change Set Up Exit Select, Press YES :15:00 Date 04 Change, Press YES :15:00 Mnth 02 Change, Press YES :15:00 Year 2009 Change, Press YES :15:10 Hur 16 Change, Press YES :15:00 Mins 15 Change, Press YES Change Set Up Exit Select, Press YES 6. Scrll t Set Time and Date 7. Change date 8. Change mnth 9. Change year 10. Change hur 11. Change minutes 12. Press YES Change Set Up Set Time & Date Select, Press YES :15:00 Date 10 Change, Press YES :15:00 Mnth 12 Change, Press YES :15:00 Year 2011 Change, Press YES :15:00 Hur 12 Change, Press YES :15:00 Mins 30 Change, Press YES Lad Syringe Press YES Press YES Press YES Press YES Press YES Press YES The Lad Syringe screen prmpt nw displays 13. Check changes by pwering ff and n, (barrel clamp arm dwn), and bserving start up screen infrmatin. Scenari 2: change prgram lck n t lck ff Scenari: Current pump set up: pump default, Lck On 24:00) 1. T pwer n, press ON/OFF key. Wait until Pre-Lading cmpletes and screen prmpt displays: Lad Syringe Inf Menu Change Set Up 2. Press the INFO key 4. Press YES Inf Menu Battery Level Select, Press YES Enter Set Up Cde 0 Change, Press YES 3. Scrll t Change Set Up 5. Enter access cde, press YES Select, Press YES When the arrw is pressed and held dwn the pump will cunt up in single digits t ten, then in tens t ne hundred and then in hundreds thereafter. Scrll t the nearest pint in tens and then release the key. Press either the r arrw individually, until the crrect cde displays then press YES t cnfirm. Change Set Up Exit Select, Press YES 6. Scrll t Prgram Lck Change Set Up Prgram Lck Select, Press YES Press YES Sftware Versin NCAT / NCATBOL 31

32 Prgram Lck ON Change, Press YES Change Set Up Prgram Lck Select, Press YES Lad Syringe 7. Change t OFF 8. Scrll until Exit displays Prgram Lck OFF Change, Press YES Change Set Up Exit Select, Press YES 9. The Lad Syringe screen prmpt nw displays Press YES Press YES 10. Check changes by pwering ff and n, (barrel clamp arm dwn), and bserving start up screen infrmatin (Prgram Lck status). Scenari 3: change frm lck n mde t rate setting (lck n) mde Scenari: Change frm Lck On Mde with default duratin f 24:00 t Rate Setting (Lck On) Mde with 2mL/hr rate. Change Default Duratin t 0 hurs in Change Set-Up Menu and enter 2 ml/hur in Rate Setting Menu. 1. T pwer n, press ON/OFF key. Wait until Pre-Lading cmpletes and screen prmpt displays: Lad Syringe Inf Menu Change Set Up 2. Press the INFO key 4. Press YES Inf Menu Battery Level Select, Press YES Enter Set Up Cde 0 Change, Press YES 3. Scrll t Change Set Up 5. Enter access cde, press YES Select, Press YES When the arrw is pressed and held dwn the pump will cunt up in single digits t ten, then in tens t ne hundred and then in hundreds thereafter. Scrll t the nearest pint in ten`s and then release the key. Press either the r arrw individually, until the crrect cde displays then press YES t cnfirm. Change Set Up Exit Select, Press YES Default Duratin 24:00 Change, Press YES Change Set Up Default Duratin Select, Press YES Lad Syringe Inf Menu Rate Setting Select, Press YES Rate setting 0ml/h Change, Press YES Lad Syringe 6. Scrll t Default Duratin 7. Change t 00:00 8. Scrll until Exit displays 9. Press the INFO key 11. Press YES 13. Change t 2mL/hur Change Set Up Default Duratin Select, Press YES Default Duratin 00:00 Change, Press YES Change Set Up Exit Select, Press YES Inf Menu Battery Level Select, Press YES Enter Rate Cde 0 Change, Press YES Rate setting 2ml/h Change, Press YES 14. The Lad Syringe screen prmpt displays Press YES Press YES Press YES 10. Scrll t Rate Setting 12. Enter access cde, press YES Press YES 15. Check if all setting changes cmpleted by simulating starting an infusin Sftware Versin NCAT / NCATBOL 32

33 SECTION 6: STARTING A NEW INFUSION 6.1 Sequence fr starting an infusin This sectin describes user actins detailed infrmatin fr starting a new infusin. The sequence t starting an infusin in this sectin is using the Prime and Lad methd f administratin set priming, which is suitable the lw-priming vlume f all CME syringe administratin sets. NOTE: An alternate sequence that may be used (Lad and Prime) is priming the set after prgramming the pump, this methd is fr sets which require a large priming vlume. The decisin fr which methd t use shuld be judged n administratin set availability, lcal circumstances and plicy. Cnsideratin must be given t clinical risk, ease f use fr the device user and cnsistency in start-up prcedure fr all wards/departments and clinical areas. Summary f the user stages required t start a new infusin Stages Lck n mde Lck ff mde Rate mde A. Preparing syringe and prime the set B. Checking the pump C. Inserting the battery D. Pwering n and bserving Pre-Lading E. Checking the battery level (via the Inf menu) F. Syringe lading, detectin and cnfirmatin G. Entering/cnfirming the prgram The number f pump screens that display will vary, depending n the mde f peratin and any additinal functins enabled r disabled within individual pump cnfiguratin. H. Starting the infusin A. Prepare syringe and manually prime the set Prepare syringe with drug(s) as per prescriptin and lcal plicy, attach drug label, ensuring the label lies flat. WARNING: D nt ver-label the syringe r apply anything that changes its external diameter at the pint where the barrel clamp is applied as incrrect syringe detectin may result. T manually prime the administratin set Preparing the syringe and administratin set: Select the crrect syringe administratin set, and remve frm packaging Attach the extensin set t prepared Luer lck syringe, maintaining sterility Remve cap frm end f extensin set Gently push syringe plunger frward until air is expressed frm the set Cap the end f the extensin set NOTE: Fr instructins n priming cannula, refer t cannula manufacturer instructins. Sftware Versin NCAT / NCATBOL 33

34 B. Check the pump Ensure that the device is clean, visually intact, apprpriate fr intended use, and within service date. It is gd practice t inspect medical equipment and accessries between patients and certainly immediately befre use (e.g. whilst setting it up n the patient). Inspectin f the pump and/r accessries shuld include checking that the: Pump is undamaged Lckbx is lcked and intact (if in use) C. Insert the battery NOTE: The battery needs t fit snugly t prevent lss f battery/pump electrde cntact. When the pump is new, it may be difficult t remve the battery until the metal electrdes lsen slightly with use and ver time. T insert the battery int the pump 1. Slide the cmpartment cver ff at the back f the pump. 2. Push the battery int the cmpartment taking care t ensure that the battery + / - cntacts are aligned n the label inside the cmpartment. 3. Slide the cver back n. D. Pwering n and Pre-Lading WARNING: d nt insert freign bjects arund r near the actuatr during autmatic actuatr mvement (Pre-Lading) r when manually adjusting the actuatr. Pwering n With n syringe is in place and barrel clamp arm dwn, press the ON/OFF key until the screen illuminates and the first screen displays: When the pump is pwered n, Pre-Lading cmmences. T34 Versin NCATxxxx ID: (Syringe Pump) Pre-Lading Pre-Lading is a simultaneus sequence f screen infrmatin displaying and autmatic actuatr mvement, during Pre-lading: The pump perfrms an internal self-test The screens display imprtant pump infrmatin Sftware Versin NCAT / NCATBOL 34

35 The actuatr mves frwards/backwards autmatically Pre-Lading deletes any prgram in the pump memry and at the end f the Pre-Lading sequence the actuatr returns t the start psitin f the last infusin. If the user regularly uses the same syringe brand, size and fills t the same vlume, pwering ff and n allws autmatic actuatr mvement which returns the actuatr t the crrect psitin each time and shuld nt require adjustment fr a new prgram/syringe. Pre-Lading nly takes place when n syringe is in place and the barrel clamp arm is in the dwn psitin. If the pump is pwered n with n syringe in place but with the barrel clamp arm raised, Pre-Lading des nt take place. WARNING: The actuatr will nly mve autmatically r manually by using the FF/Back keys (with n syringe in place and barrel clamp arm dwn). D nt use frce t try t mve the actuatr manually as this culd cause damage t the device and/r affect calibratin. If the keypad lck is n, when a pump is pwered n (with n syringe in place and barrel clamp arm dwn), Pre-Lading will nt take place and the actuatr cannt be mved manually using the FF/Back keys. During Pre-Lading the fllwing screens display in sequence: T34 Pump identificatin Versin NCATxxxx The pump displays the mdel name, sftware versin number and pump identificatin. ID: (Syringe Pump) The default identificatin name (ID) is Syringe Pump ; this can be cnfigured via BdyCmm t e.g. asset number r user site, up t a maximum f 17 digits. Pre-Lading Use NO t Interrupt Advisry ntice It is advisable nt t interrupt the autmatic actuatr mvement t ensure that a previus prgram is deleted. If the user pressed NO, the actuatr stps mving and the Lad Syringe screen will display. Pump default settings Occlusin xxx mmhg Line 1 - Occlusin pressure setting Max Rate 5ml/h Line 2 Pump maximum ml/hur Rate that can be set Prgram Lck ON Line 3 - Prgram lck status Battery * During Status actuatr 99% mvement Line 4 this - Battery value fluctuates, status* d nt rely n this figure as the true battery percentage. Lad Syringe On cmpletin f Pre-Lading the screen displays. This screen displays and flashes until a syringe is detected in all three syringe sensrs. Prcedure fr releasing a trapped, freign bject frm actuatr If an bject /finger is trapped either during Pre-Lading r when manually adjusting the actuatr, the alarm and screen prmpt that displays will depend n the battery % level and the frce/resistance mving against the actuatr. Alerts r alarms that may display include lw battery alert, end battery alarm, system failure alarm r a high mtr current alarm. The screen prmpts and advice fr each alert and alarm is different, therefre, ignre screen prmpts as the prmpt that may display is in relatin t alarm activatin and NOT the trapped bject. Sftware Versin NCAT / NCATBOL 35

36 If a freign bject /finger is trapped in frnt f, r behind the actuatr during Pre-Lading (autmatic actuatr mvement) r when manually adjusting the actuatr, the user shuld: Optin 1 (manual adjustment f actuatr) 1. Pwer the pump ff 2. With the pump psitined with frnt f pump facing. 3. T mve the actuatr twards the barrel clamp arm, place finger n guide screw and rll finger twards the pump screen/keypad ( ). 4. T mve the actuatr twards the frnt f the pump, place finger n guide screw and rll finger twards the battery cmpartment ( ). Back f pump (battery cmpartment area) Frnt f pump (screen and keypad area). Optin 2 (adjustment f actuatr using FF/Back keys) 1. Pwer the pump ff 2. Raise the barrel clamp arm and turn it left r right t keep it in the raised psitin 3. Pwer n 4. Turn and lwer the barrel clamp arm 5. Use the FF (r Back key) key t release the bject Event lg interpretatin f alarms Interpretatin f the pump event lg can assist in identifying the effects n the pump with an bject being trapped in frnt f, r behind the actuatr. Recrded events will reflect the alarm that was activated at the time. If a lw r end battery alarm is activated, yu may see that the battery vltage has drpped substantially and the activatin f a lw r end battery alarm is dependent n the battery % level at the time f the alarm. Sftware Versin NCAT / NCATBOL 36

37 E. Check the battery level Check the battery level via the Inf menu The LED light will be display red (n infusin running) Lad Syringe 1. Press INFO key Inf Menu Battery Level Select /, Press YES 2. Press YES Battery Level Empty Full 90% 3. Wait a few secnds fr this screen t display: Lad Syringe F. Syringe lading, detectin and cnfirmatin Manual adjustment f the actuatr 1. Ensure the barrel clamp arm is dwn. 2. Place the prepared syringe abve the pump t visually align the syringe cllar t the cllar sensr. 3. Use the FF/Back keys (if required), t mve the actuatr t the crrect psitin fr placing the syringe cllar and plunger int the matching pump sensr areas. Syringe lading 1. Lift the barrel clamp arm fully and turn the arm 90 (either way). 2. Place the syringe cllar vertically int the pump cllar slt and the syringe plunger int the pump plunger slt, (the syringe shuld click int psitin). 3. Turn and lwer the barrel clamp arm nt the syringe. As yu crrectly seat each pint f the syringe, the flashing indicatr fr that sensr becmes slid n the screen display, when all three sensrs detect, a syringe size and brand will display. Syringe detectin and cnfirmatin The pump identifies the syringe brand, size and vlume by measuring the syringe dimensins frm the three sensrs. 1. Check that the syringe brand and size inserted int the pump matches the syringe brand and size displaying, if they match cnfirm by pressing YES. Incrrect syringe size/brand detected Pump identifies a syringe brand which is different frm the ne being inserted, this can be caused by: Sftware Versin NCAT / NCATBOL 37

38 The syringe is nt crrectly fitted int the 3 sensr areas and the syringe detected has dimensins within (+/-) 1mm f a syringe brand in the syringe library. Over-labelling f the syringe r applying anything that changes its external diameter at the pint where the barrel clamp is applied. T rectify: Scrll between brands f similar dimensins using the / arrw keys. When the crrect syringe displays, press YES/START key t cnfirm and cntinue prgramming. Failure t detect a syringe Failure t detect any brand/size f syringe can be caused by: The syringe is psitined incrrectly r nt fully int any r all the sensrs. The syringe brand/size being fitted may nt be cnfigured t the pump. T rectify: Repsitin r refit the syringe ensuring the syringe is firmly placed int the 3 sensr areas. The screen prmpt will indicate which sensr is affected. Re cllar sensr: ensure the cllar f the syringe is facing dwnwards int the slt as the sensr is psitined at the bttm f the slt. Either use a cmpatible syringe brand r arrange fr the new type f syringe brand t be cnfigured int the pump by authrised persnnel. NOTE: Enabling/disabling f syringe brands is carried ut via the BdyCmm cmmunicatins dcking statin and PC sftware. Any new brands f syringes that may becme available in the future can be measured and cnfigured int the pump. WARNING: Never take a syringe that is nt empty ff the pump if it is still cnnected t the patient. The infusin line must be discnnected r clamped befre remving the syringe t prevent free flw and the risk f serius injury r death t the patient. WARNING: If the Vlume t be Infused displayed n the pump LCD after cnfirming the syringe varies by mre than 5% f the actual syringe vlume visually cnfirmed n the syringe scale, remve the syringe, turn ff the pump and, with the barrel clamp arm dwn, turn the pump n t allw Pre-Lading t ccur. Repeat the syringe placement and detectin steps and ensure the crrect syringe size and brand are cnfirmed. If the calculated vlume reading is still significantly different frm the visually cnfirmed cntents, remve the pump frm use and return t an authrized service center fr inspectin, testing and calibratin. WARNING: Using a syringe nt apprved by the pump manufacturer r a syringe type which is nt cmpatible with syringe drivers culd affect device perfrmance, resulting in ver-delivery r under-delivery f medicatin t the patient. G. Entering/cnfirming the prgram When prgramming the pump fr a mde f peratin, specific screens and user interactins will depend n the pump cnfiguratin fr lcal use. This sectin demnstrates typical prgramming using the prime and lad methd fr the fllwing mdes: Lck On mde fixed duratin Lck Off mde adjustable duratin Rate mde (Lck ON) - fixed ml/hur rate Rate mde (Lck OFF) - adjustable ml/hur rate Sftware Versin NCAT / NCATBOL 38

39 Lck On mde fixed duratin Fllwing syringe cnfirmatin, the prgram summary displays: Vlume 12 ml Duratin 24:00 Review the infusin/prgram summery t check that the parameters displayed match Rate 0.5 ml/h the prescriptin: visibly check the vlume/duratin/rate, t cnfirm infusin, press YES. Cnfirm, Press YES (The ml/hur rate has been calculated frm the syringe vlume and fixed duratin) Lck Off mde adjustable duratin Fllwing syringe cnfirmatin, the prgram sequence cmmences: Occlusin xxx mmhg Max Rate 5ml/h Prgram Lck OFF Battery Status xx% Review pump cnfiguratin settings and wait fr next screen prmpt. 20ml BD Plastipak Vlume 12 ml Change /, Press YES 20ml BD Plastipak Duratin 2400 Rate 0.5 ml/h Change /, Press YES Duratin Changed, Check Rate 20ml BD Plastipak Rate 1.0 ml/h Cnfirm, Press YES Visibly check if the vlume in the syringe matches the vlume displayed. Change if necessary, cnfirm by pressing YES. Change duratin if necessary, by using +/- keys, cnfirm by pressing YES If the default duratin is changed this screen displays fr a few secnds The rate displays (calculated frm the syringe vlume divided by the duratin cnfirmed), check and cnfirm by pressing YES Vlume 12 ml Review the infusin/prgram summery t check that the parameters displayed match Duratin 12:00 the prescriptin: visibly check the vlume/duratin/rate, t cnfirm infusin, press YES. Rate 1.0 ml/h Cnfirm, Press YES (The ml/hur rate has been calculated frm the syringe vlume and cnfirmed duratin). Rate mde (Lck ON) - fixed ml/hur rate Fllwing syringe cnfirmatin, the prgram sequence cmmences: Occlusin xxx mmhg Max Rate 5ml/h Review pump cnfiguratin settings and wait fr next screen prmpt. Prgram Lck ON Battery Status xx% Vlume 12 ml Review the infusin/prgram summery t check that the parameters displayed match Duratin 24:00 the prescriptin: visibly check the vlume/duratin/rate, t cnfirm infusin, press YES. Rate 0.5 ml/h Cnfirm, Press YES (The duratin has been calculated frm the syringe vlume and fixed ml/hur rate). Sftware Versin NCAT / NCATBOL 39

40 Rate mde (Lck OFF) - adjustable ml/hur rate Fllwing syringe cnfirmatin, the prgram sequence cmmences: Occlusin xxx mmhg Max Rate 5ml/h Review pump cnfiguratin settings and wait fr next screen prmpt. Prgram Lck OFF Battery Status xx% 20ml BD Plastipak Vlume 12 ml Change /, Press YES 20ml BD Plastipak Rate 0.0 ml/h Change /, Press YES 20ml BD Plastipak Rate 2.0 ml/h Change /, Press YES Visibly check if the vlume in the syringe matches the vlume displayed. Change if necessary, cnfirm by pressing YES. If rate setting disabled, the default f 0mL/hur will display Enter the infusin rate required, cnfirm by pressing YES. If rate setting enabled, the cnfigured ml/hur value will display Change r cnfirm the infusin rate, cnfirm by pressing YES. Vlume 12 ml Review the infusin/prgram summery t check that the parameters displayed match Duratin 6:00 the prescriptin: visibly check the vlume/duratin/rate, t cnfirm infusin, press YES. Rate 2.0 ml/h Cnfirm, Press YES (The duratin has been calculated frm the syringe vlume and cnfirmed ml/hur rate). H. Start infusin (all mdes) Cnnect t patient At this pint, site/cnnect the cannula/administratin set t the patient. Fllw lcal plicy fr the recmmended cannula and set t use. Start Infusin? T cmmence the infusin, press YES/START Check and cnfirm infusin is running Visually check that the infusin running screen is visible and the green LED light flashes intermittently. When the pump is perating, nte that the bttm line alternates between the syringe brand and size cnfirmed and "Pump Delivering" (with mving chevrns): Time Remaining 24:00 Rate 0.50 ml/h <<<< Pump Delivering The last line alternates Time Remaining 24:00 Rate 0.50 ml/h 20ml BD Plastipak Sftware Versin NCAT / NCATBOL 40

41 SECTION 7: MONITORING AND MANAGING INFUSIONS 7.1. Pump and infusin safety checks Ensure that the device is clean, visually intact, apprpriate fr the intended use, and within service date. It is gd practice t inspect medical equipment and accessries between patients and certainly immediately befre use (e.g. whilst setting it up n the patient). It is recmmended that prcedures are established fr regular checks n the pump, accessries and the prgress f the infusin. Inspectin f the pump and/r accessries shuld include checking: Fr signs f physical damage t the pump and lckbx Pump is psitined crrectly Lckbx is lcked and lines are psitined safely Pump psitining It is gd practise t minimised disturbance t the pumps and t maintain the pump at the same level thrughut an infusin as far as pssible. Optimal peratin ccurs with psitive pressure infusin devices are psitined at the same level as the infusin site. It is gd practise t adpt this advice where pssible. WARNING: if a pump has been accidentally damaged, drpped r subject t fluid ingress/spillage it shuld be withdrawn frm service immediately and a suitable replacement pump lcated. Cntact yur lcal service centre. T cnfirm the infusin is in prgress a) The pump LED light will intermittently flash green b) The LCD screen will display infrmatin: Line 1 - displays infusin time remaining Line 2 - displays the ml/hur infusin rate Line 3 - alternates between the syringe size and brand cnfirmed by the user during set up and <<<< Pump Delivering Regular mnitring shuld include checking: Battery level Syringe vlume histry Keypad lck is n (if in use) NOTE: Fllw lcal guidance fr a full list f infusin mnitring checks. Sftware Versin NCAT / NCATBOL 41