CME T34L, Operator'S Manual

Page 1: ...yringe Pump Operator Manual 0344 Caesarea Medical Electronics Ltd MedNet GmbH 16 Shacham street North Industrial Borkstrasse 10 Park Caesarea 48163 Muenster P O Box 4294 Caesarea 38900 Israel Germany Tel 972 46271737 T 49 251 32266 0 www cme infusion com ...

Page 2: ...ng the device It is also recommended that before being allowed to use the device all personnel should receive training from either Caesarea Medical Electronics Ltd CME or those trained by Caesarea Medical Electronics Ltd CME to deliver training on this device Competency of all attendees should be assessed with both the trainee and assessor signing to confirm their readiness to operate the device i...

Page 3: ...ming 14 Alarms Verification 14 Syringe Selection 14 Priming the Administration Set 14 Pre Loading Syringe Placement 14 Power Up 14 Syringe Detection Confirmation 15 Setting Infusion Parameters 16 Setting the Infusion Rate 16 9 Accessories 18 Carry Pouch 18 Pole Mounting Unit 19 10 Recommended Checks during Infusion 20 Event Log History 20 11 Advanced Functions 21 KVO Keep Vein Open Operation 21 12...

Page 4: ...on routes including central peripheral venous epidural intra arterial or subcutaneous providing the medicines being administered are licensed for such use Warning Do not operate the T34L TM until you have read and understood the contents of this user manual paying attention to Warnings Cautions Notes as described below This manual will ensure the user will 1 Be able to identify the key features of...

Page 5: ...t This prevents programming errors and makes setting up an infusion very simple User CANNOT change either the VTBI or the Default Duration time Pump calculates the volume applies the pre set duration and calculates the appropriate rate for the infusion User only checks and confirms infusion summary screen showing duration rate and volume matches the prescription before Starting the infusion User a...

Page 6: ...d light Lights when the pump is in a stand by mode during programming 2 Plus key Scrolls between options 3 NO STOP key a Takes user back a step b stops pump 4 1 Infra Red sensor 5 ON OFF key Switches the pump on and off 6 Forward key 7 YES START key Confirms choices 8 Minus key scrolls between options 9 Backward key 10 Info key a shows technical data and Battery status b Long press will Lock Unloc...

Page 7: ...ns 0344 CE mark indicates conformance to Medical Device Directive 93 42 EEC Do not dispose of in municipal waste Symbol indicates separate collection for electronic equipment WEEE Directive 2002 96 EEC NOTE Does not apply to the battery Do not dispose of battery in municipal waste Symbol indicates separate collection for battery is required The use of single use disposable components on more than ...

Page 8: ...blood and blood products o Infusion of insulin o Infusion of critical medications whose stoppage or interruption could cause serious injury or death o Use in ambulatory regimens by patients who do not possess the mental physical or emotional capability to self administer their therapy or who are not under the care of a responsible individual Warnings To avoid the possibility of injury or death ple...

Page 9: ...s and do not re use single use sets Warning Do not operate the pump near high energy radio frequency emitting equipment such as electro surgical cauterizing equipment as this may result in false alarm signals or error messages being displayed Warning The maximum volume that may be infused under SINGLE FAULT CONDITION is 0 15 ml depending on syringe size in use Warning The equipment is not suitable...

Page 10: ...mbulatory being moved or even during electrical power failures Fully charged the battery provides 15 17 hours of operation at an infusion rate of 125 ml h Wall Charger To charge the battery connect the charger plug to mains power supply and to the pump DC connector on the rear of the pump Note that the DC connector must be inserted directly in the correct way NOTE After the End Battery signal has ...

Page 11: ...he procedures below Check the Start Up Screen displayed on power up indicating battery life remaining Press INFO key when the pump is stopped and select Battery Level press YES to view battery meter During infusion press the INFO key twice to check Battery Level in all cases verify sufficient battery charge is available to complete the current program If not charge the battery Sufficient battery c...

Page 12: ...ring an IV infusion can cause death or serious injury to the patient Do not connect a patient to the T34L TM Syringe Pump until all air has been cleared from the fluid path syringe Carefully read the instruction for loading Puncturing set components could result in air embolism Warning Drugs must not be administered to the epidural space unless indicated for this purpose and administered in accord...

Page 13: ...figurable settings and features and is protected by a user code from un authorized access Technicians Menu used for service and or repair of the Pump is also protected by a special access procedure and different user code from that for Change Set Up In normal use the nurse will not see these fields or be prompted for the technician codes Keypad Lock As well as the ability to lock or limit certain ...

Page 14: ...ministration set prime manually and apply the clamp Warning Never connect to the patient before loading the syringe into the pump Pre Loading Syringe Placement 2 Before turning the pump on ensure the syringe is not fitted and the barrel clamp arm is down Power Up 3 Press ON OFF key to power the pump up Screen displayed during pump Self Test shows 1 Pump model name 2 Software version 3 Pump ID defa...

Page 15: ...ly loaded the graphic right will become solid no flashing components and the pump will display the Size and Brand of the syringe detected Warning Do not over label the syringe or apply anything that changes its external diameter at the point where the barrel clamp is applied as incorrect syringe detection may result leading to the pump running at an inappropriate speed for the syringe loaded Syrin...

Page 16: ...ge scale remove the syringe turn off the pump remove the pump from use and return to an authorized service centre for inspection testing and re calibration 15 Press YES START key to confirm VTBI 16 VOLUME OVER TIME MODE ONLY The LCD display prompts the user to set the infusion Duration Press YES to confirm the Default Duration or use the arrow keys to change the duration then press YES NOTE Every ...

Page 17: ...application the pump is regularly used for Pump will not allow the user to scroll to a duration that requires a rate above this limit to deliver the contents of the syringe over that time 19 The Summary Screen displays the Volume To Be Infused Duration and Infusion rate Warning Always take time to check the contents of the summary screen match the prescription before starting infusion 20 Press YES...

Page 18: ...ing the pump with a CME Ltd pouch or similar receptacle during transportation or patient ambulation whilst the pump is infusing protects the pump functionality and the medication in the syringe from exposure to direct sunlight The pouch will also protect the pump from damage or syringe displacement When using the CME Ltd re useable washable pouch it is possible to access the screen and keypad of t...

Page 19: ...ole mountable vertically of horizontally Connect the pole mounting unit to the pole using the adjusting screw and just click in the T34L TM back hooks onto the pole mounting unit Mounting device for two syringe pumps is also available Back hook Release handle Adjusting screw ...

Page 20: ...e and in graph form NOTE After pressing the INFO key either a third press or waiting a few seconds returns the display to the main infusion display screen Excessive key presses or usage of the INFO feature will reduce battery life Use only as required to optimize battery performance Event Log History The event log shows a complete time and date stamped record of the last 512 pump events along with...

Page 21: ...bled the pump requires the user after confirming the infusion rate calculated during programming to set a maximal minimal rate To titrate the rate up or down during infusion follow these steps Use the UP or DOWN arrows on the keypad to adjust the rate to the desired new setting as displayed on the main LCD screen Press YES within a few seconds of making the change to confirm the new rate Pump soun...

Page 22: ...yringe Press YES to confirm One or more of the syringe detection sensors is not detecting up the syringe Check the syringe and re seat as necessary Pump Paused Too Long Pump has been left in STOP mode with no keypad presses detected for 2 minutes Start the infusion continue programming or turn the pump off if not needed Near End 15 minutes from End of Infusion Prepare to change syringe or turn pum...

Page 23: ...n The Pump will not start Battery is depleted very low Pump is faulty Charge battery Service required The infusion is going too quickly has ended early or too slowly volume remaining in syringe at end of infusion Incorrect rate set Wrong syringe brand confirmed during set up Pump faulty or incorrectly calibrated Check displayed rate against prescription change if necessary Re train user to prevent...

Page 24: ...nd the significance of that parameter and the effect your change will have on the operation and or functionality of the pump If correct code has been inputted and confirmed the Set Up menu will be displayed Parameter Application Range Set Time Date Ensures all events in log are correctly date and time stamped ensure local update for DST FF Key Operation Limits the forward movement of actuator caus...

Page 25: ...d Syringe Travel Low Battery End Battery Pump Paused Lock Mode Syringe Displaced Check Syringe Placement T34L TM Dimensions 205X98X45 mm Classification Type CF Equipment Housing ABS fire retardant Weight 411 gr with battery Electrical Safety Complies with EN 60601 1 Medical Electrical Equipment Safety IEC 60601 2 24 Infusion pumps and controllers IEC 62304 Medical device software Software life cyc...

Page 26: ... dampened with warm water and mild detergent or 10 bleach solution Caution Do not soak or immerse any part of the T34L TM in water or any other solution Storage If the pump is to be stored for an extended period it should be cleaned Store in a clean dry atmosphere at room temperature and if available use the original packaging or a suitable alternative for protection Service The Pump must only be ...

Page 27: ...nsult a biomed engineer or your local T34L TM distributor should this need arise Time to Alarm from Occlusion The Time to Alarm from Occlusion for the T34L Syringe Pump are in accordance to the table below All the tests were performed using a CME extension set 100 172S and a BD Plastipak syringes filled with water Time to Alarm from Occlusion Manufacturer Size Rate 300mmHg 600mmHg 900mmHg BD Plast...

Page 28: ...y Material returned to CME or its designated representative should be properly packaged using CME shipping cartons and inserts Inadequate packaging may result in damage to the pump This Limited Warranty shall not apply to defects or damage caused wholly or in part by negligence spilt fluids dropping of the pump misuse abuse improper installation or alteration by anyone other than qualified trained...