Accumate 2300 Volumetric Infusion Pump

Accumate 2300 Volumetric Infusion Pump Operating Manual www.wooyoungmed.com Log o

Important This Operating Manual is for clinician use only. Do not permit patients to have access to this Operating Manual. Please read the entire Operating Manual before operating the Accumate 2300 volumetric infusion pump. Failure to properly follow warnings, cautions and instructions could result in death or serious injury to the patient. 2

Warnings If the pump is used to deliver life-sustaining medication, an additional pump must be available. Prior to use, always check the audible and visual alarms. The pump is not to be used for delivery of blood or cellular blood products. Do not use this pump on mains power if the integrity of the protective earth system is suspect. To prevent a possible explosion hazard do not use this pump in presence of inflammable anesthetic gases. Do not use this pump in close proximity to equipment such as surgical diathermy with generates high levels of RFI. Do not permit the use of mobile telephones in wards where this pump is in use. If the pump is dropped or hit, inspect the pump for damage. Do not use a pump that is damaged or not functioning properly. Contact Customer Service to return a pump for service. Do not permit this pump to used if standing in a pool of liquid. System delivery inaccuracies may occur as a result of back pressure or fluid resistance, which depends upon drug viscosity, catheter size, and extension set tubing. 3

Warnings Always read and follow the manual that accompany the source container and IV administration sets you are using. Carefully follow the manual for loading, removing, and reloading the set, as well as recommended set change intervals. Change pumping section on tubing every 24 hours. Do not use tubing for more than 72 hours. Always check pump data prior to starting infusion. After starting an infusion, make sure drops are falling in the drip chamber. If no drops are falling, make sure the roller clamp is open. If the roller clamp is open and still no drops are falling, replace and dispose of the set. The air detector cannot recognize the introduction of air at 3-way stopcocks, infusion ports, and other lines/tubes below the pump. To avoid mechanical or electronic damage, do not steam autoclave or immerse the pump in any fluids or cleaning solutions. Always disconnect electrical power cord from outlet before cleaning to prevent electrical shock. 4

Cautions Do not operate the pump at temperatures below +10 C(50 F) or above 40 C(104 F) and humidity levels below 30% or above 85%. Do not store the pump at temperatures below +5 C(41 F) or above 40 C(104 F) and humidity levels below 10% or above 90%. Do not store the pump with the Administration Set attached. Do not store the pump for prolonged periods with the battery installed (above 3months). Do not immerse the pump in cleaning fluid or water or allow solution to soak into the pump, accumulate on the key pad, or enter the battery compartment. Do not clean the pump with acetone, other plastic solvents, or abrasive cleaners. Do not use the pump to therapeutic levels of ionizing radiation. Do not use the pump directly to ultrasound. Do not use the pump in the vicinity of magnetic resonance imaging (MRI) equipment. Do not use the pump near ECG equipment. Do not sterilize the pump. All service and repair of the Accumate 2300 pumps must be performed by Woo Young Medical or its authorized agents. 5

Table of Contents Introduction... 7 Features of the Accumate 2300 Front View & Key Pad...8 Controls and Indicators...9 R e a r V i e w........................................................... 10 Directions for Operation Preparation of the IV-set...12 Turning ON the Power - Rear...13 Turning ON the Power - Front...14 Insertion of the IV-set...15 Setting the Flow Rate and Delivery Limit...17 Clearing the Volume Delivered...18 Operating the Pump...18 Purge Infusion (stop mode)...19 Bolus Infusion (start mode)...19 T itration...20 Data Lock...21 Adjust Sound... 22 Occlusion Level... 23 Near End of Infusion...24 End of Infusion... 25 Alarms and Troubleshooting...26 Specifications... 28 Maintenance Routine Maintenance Procedures...30 Cleaning and Storage...31 Replacing the AC fuses...32 Battery operation... 33 Occlusion Pressure Limits...34 Start-up & Trumpet Curves...35 Warranty...38 Service and Packaging... 39 Contact... 40 6

Introduction The Accumate 2300 volumetric infusion pump is a fully featured infusion pump suitable for critical care and generation applications. The Advantages High precision. Purge, automatic & manual bolus capability. Easy to operate in only three steps. Power On > Select (rate, total, VTBI) > Start Easy to read, large display. History function. Historical data of infusion records. (warnings, settings, starts and stops of infusion, etc.) Micro-infusion for neonatal and high risk application. None dedicated sets, available from various manufacturers. Programmable, ultrasonic air bubble detector. Multi-position clamp for vertical or horizontal fixation to poles. SAFETY STANDARD The Accumate 2300 meets all safety standards for medical electrical devices, corresponding to IEC 60601-1 and IEC 60601-2-24. 7

Features of the Accumate 2300 -Front View & Key Pad b c d e a n m j l k i f g h o p q r s t u 8 y x w v

Controls and Indicators NO. Name Function a Handle To handle for carrying b Name Plate To display the pump model and name c Display All essential information is displayed (flow rate, delivery limit, volume delivered, alarms information) d Locker To lock pump door e Key Pad To set infusion data f Finger To squeeze the tube with the spring housing by peristaltic motion g Occlusion Sensor To detect the downstream occlusion of the tube h Clamp Lever To prevent free flow when the pump door is opened i Spring Housing To squeeze the tube with the peristaltic fingers j Door Handle To lock pump door with locker k Door To protect the tubing set when running l Door Magnet To detect whether the door is open or not m Bubble Sensor To detect air in the tube n LED To indicates pump is infusing or lights up during an alarm (normal : green, malfunction : red) 9

Controls and Indicators NO. Name Function o Volume Delivered Displays Volume Delivered (VTBI:Volume To Be Infused) p Delivery Limit Displays delivery limit or alarms information q Flow Rate Displays flow rate (infusion rate) r s t SELECT /SILENCE BATTERY LEVEL EXTERNAL POWER To select setting mode (flow rate, delivery limit, volume delivered) / To silence alarm for 2minutes To display the charging status of internal rechargeable battery To inform whether the external power is connected or not u PURGE To access PURGE or BOLUS key v POWER ON/OFF Press once to switch the pump ON. Press and hold down for 2 seconds to switch the pump OFF w START To start the infusion x STOP /CLEAR To stop the infusion /To clear the value when setting data y UP/DOWN To increase or decrease of value shown on display 10

Features of the Accumate 2300 -Rear View a b l c d k e j f g h i NO. Name Function a Multi-position Clamp To fix the pump to vertical pole stand or horizontal bar of bed b Rear Support To support to pole stand c Drop Sensor Port To connect the drop sensor with the pump d Nurse Call/ Comm. Port To connect the nurse call jack or communication cable e Front Panel Lock Switch To lock the front key pad f 12V DC Jack To supply the power of 12V in ambulance car g Protective Ground To connect the protective earth line h Spec Plate To inform the product information i AC Outlet/Fuse Socket To connect the AC 90~245V main power cord where the 1.25A fuse is j Rechargeable Battery To hold the NIMH rechargeable battery k Power Switch To switch the main power l Clamp Knob To fix the clamp 11

Direction for Operation Preparation of the IV-set Check for cleanliness, completeness, and damage. If unit appears damaged, do not use it. Check the IV administration sets. If other IV administration sets are used, the operating safety of the pump can no longer be guaranteed. Patient safety may, as a result, be compromised. Recommended IV-set BD(BECTON DICKINSON) :A122 KV(KOREA VACCINE) :143T/243T Carefully purge the infusion set, without allowing any air bubbles to enter, until the drip chamber is to 1/3 full. If air has entered, repeat purgeprocedure. Close the tubing roller clamp. chamber 1/3 close 12

Direction for Operation Turning ON the Power - Rear Attach the pump to an IV pole by turning the knob on pole clamp. Plug the pump's power cord into an electrical outlet. Turn ON the MAIN POWER switch. MAIN POWER switch must be ON to charge the battery. 13

Direction for Operation Turning ON the Power - Front Check whether the AC power LED is turned on. External Power LED display will light. Press the POWER ON key on the front panel. When turning the pump OFF, the pump must be at STOP mode in order for the POWER key to respond. Wait the self test procedure. Check the previously used data. 14

Direction for Operation Insertion of the IV-set Insert the IV-set chamber into the IV bottle/bag. Fill 1/3 of the chamber. Take cautions to avoid any air bubbles. Open the door by pulling the DOOR HANDLE. Completely insert the IV-set into the BUBBLE SENSOR. Push the CLAMP LEVER to right to open. Place the IV-set into the clamp. This is a safety feature that prevents free flow when the door is opened during infusion. 15

Direction for Operation Insert the IV-set in the occlusion guide. Check if the IV-set is straightforward. CAUTION : Make sure that IV tube is NOT loosely fastened into the internal chamber of the pump. It should be straightforward. Close the door by pushing the tightly DOOR HANDLE. The roller clamp should be below the pump. Open the roller clamp to be ready to infuse. Check that no drops are falling in the drip chamber. 16

Direction for Operation Setting the Flow Rate and Delivery Limit Press the SELECT key. The digits in the LED digital display will blink in 7seconds. Use the UP( ) DOWN( ) keys to set the desired rate of infusion. The rate of infusion can be set from 0.1 to 999.9ml/hr. Press the SELECT key. The digits in the LED digital display will blink in 7seconds. Use the UP( ) DOWN( ) keys to set the desired volume to be infused. The volume to be infused can be set from 0.1 to 9,999ml. 17

Direction for Operation Clearing the Volume Delivered Press the SELECT key. The digits in the LED digital display will blink in 7seconds. Press the STOP/CLR key. Operating the Pump Press the START key. Check the three LED turned on sequentially. 18

Direction for Operation Purge Infusion (stop mode) Press and hold the PURGE key when the pump is not infusion. Press and hold the PURGE key until fluid flows and the purging of the IV-set is complete. CAUTION : PURGE will infuse at the rate of 999.9ml/hr. The volume used during purging will be displayed, but it is not added to the volume delivered. The pump will not purge if the lock has been enabled. Bolus Infusion (start mode) Press the PURGE key when the pump is infusion. PURGE will infuse at the rate of 999.9ml/hr. The feature allows a bolus to be given during an infusion. Enter the amount of bolus to be given in ml and Press the START key. The amount of bolus can be set from 1.0 to 99.9ml. 19

Direction for Operation Titration (To change the flow rate while infusing) Press the SELECT key. The digits in the LED digital display will blink in 7seconds. Use the UP( ) DOWN( ) keys to set the desired rate of infusion. The rate of infusion can be set from 0.1 to 999.9ml/hr. Press the START key. CAUTION : The pump will not titration if the lock has been enabled. 20

Direction for Operation Data Lock (This features prevents unauthorized use by locking out all key except SILENCE key.) Turn ON [KEY LOCK] button to lock the key pad on the front panel. Press the any key and check the displayed in '----'. Check the set up and pump status again. 21

Direction for Operation Adjust Sound (This feature allows the volume of the alarm tone to be changed) Turn ON [KEY LOCK] button to lock the key pad on the front panel. Press and hold the SELECT key and UP( ) /DOWN( ) keys to increase or decrease the sound level. Select the volume of the alarm tone to be changed. caution : The volume of the alarm to change can be set from 1(45dB/1m) to 5(65dB/1m) 22

Direction for Operation Occlusion Level (The pressure at which a downstream occlusion alarm will be triggered varied. The higher the pressure limit, the less sensitive the pump is changes in fluid resistance.) Turn ON [KEY LOCK] button to lock the key pad on the front panel. Press and hold the SELECT key and UP( )/DOWN( ) keys to increase or decrease the occlusion level. Select the occlusion level to be changed. caution : The occlusion level to change can be set low(7± 2psi), center(11± 3psi), or high(15± 3psi). 23

Direction for Operation Near End of Infusion (Sets the near end of infusion warning time, as time left to End of Infusion.) Turn ON [KEY LOCK] button to lock the key pad on the front panel. Press and hold the SELECT key and UP( )/DOWN( ) keys to increase or decrease. Select the near end of infusion to be changed. caution : The end of infusion to change can be set from 0(no set) to 15minutes. 24

Direction for Operation End of Infusion (The pump has reached the end of the infusion) In certain conditions the Accumate 2300 automatically switches to the KVO (Keep-Vein- Open) rate. The KVO-rate is set to 1.0ml/hr. However, if the flow-rate set by the user is lower than 1.0ml/hr, the KVO-rate is equal to flow-rate. This alarm occurs 5 minutes before infusion is completed. Press the SILENCE key. This alarm occurs when infusion is completed. (KVO : Keep Vein Open) Press the STOP key to reset. 25

Alarms and Troubleshooting Alarms are indicated by a combination of an audible alarm, flashing alarm indicator and abbreviated message in the display. First press the SILENCE key to silence the alarm for a maximum of 2 minutes, then check the display for an alarm message. Press the STOP key to cancel the alarm message. If the infusion has stopped, rectify the cause of the alarm then press the START key resume the infusion. 26

Alarms and Troubleshooting Alarm Indication & Sound Air-in-line Air bb-bb-bb Door Open OPEn bb-bb-bb Occlusion OccL bb-bb-bb Drive Error Err bb-bb-bb Low battery BAtt b-b-b End of infusion End, conp b-b-b No Good ng-? silence Possible Cause Air bubble air-in-line sensor IV tube not properly inserted into the Bubble Sensor Door opened during infusion Downstream tubing kinked Filter blocked Closed roller clamp IV positional or infiltrated Catheter or vein too small Occlusion limit too low Motor malfunction Mechanical error 30 minutes until battery is fully discharged Programmed infusion is complete Self-Test NG Internal Malfunction 27 Action Remove the air from the tube Completely insert the IV tube into the Bubble Sensor Close the door Correct kinks Correct blocked filter Open roller clamp Check IV site Increase occlusion limit Request A/S Request A/S Connect pump to AC power Stop infusion and reset Request A/S

Specifications Name Volumetric Infusion Pump Model Accumate 2300 Pumping System Flow Rate Range Delivery Limit Range Total Volume Purge Rate Range Accuracy KVO( Keep-Vein- Open) Linear peristaltic 0.1-999.9ml/hr (0.1ml/hr increments) 0.1-999.9ml (0.1 ml increments), 1,000-9,999ml(1ml increments) Equals to the upper limit of the delivery limit range Equals to the upper limit of the flow-rate range +/- 5% nominal 0.1-5.0ml/hr(0.1ml/hr increments) Adjustable occlusion[5.8-17.4psi(3 level : low, center, high) Adjustable alarm volume (level up or down) Infusion completed Alarms Low battery(30 min. before infusion stop) Battery depleted(3 min. before power off) Air-in-line Door open Drive error Near End of Infusion Titration while running Others Self testing (System check) One key bolus Front panel lock 28

Specifications EMS Electrical Safety Dimensions Weight Power Requirements Battery Battery Operation Battery Charging Time DC 12V Class I, Type BF 140(W)*225(H)*140(D)mm Approximately 2.5Kg AC 90-245V, 50/60Hz Built-in rechargeable dc 12V(NI-MH 2.3Ah) Ca. 4hr @ 100ml/hr 7hrs Operation Conditions 10-40 (Relative humidity 30-85%) Storage Conditions 5-40 (Relative humidity 10-90%) Accessories Warranty Options AC power cord for 220V, Operating manual 2 years from the date of delivery RS-485, nurse call, drop sensor CAUTION : Specifications are subject to change without notice. 29

Maintenance Routine Maintenance Procedures To ensure that pump remains in good operating condition, it is important to keep it clean and carry out routine maintenance procedures described below. All servicing should only be performed by a qualified service engineer with reference to the Technical Service Manual for this product. As required Thoroughly clean external surfaces of the pump before and after prolonged period of storage. At least once per year Inspect AC power supply plug and cable for damage. Perform functional tests as outlined in the Technical Service Manual. Operate the pump on battery power until the battery low alarm then charge the battery to confirm battery operation and charging. 30

Maintenance Cleaning and Storage Before the transfer of the pump to a new patient and periodically during the use, clean the pump by wiping over with a lint-free cloth lightly dampened with warm water and a standard disinfectant/detergent solution. Disinfectants which are known to be corrosive to metals must not be used. Concentrated Isopropyl alcohol based cleaners will degrade plastic parts. The IV-set and extension lines are disposable single use items and should be discarded after use according to their manufacturers' instructions. If the pump is to be stored for an extended period it should be first cleaned and the internal battery fully charged. Store in a clean, dry atmosphere at room temperature and, if available, employ the original packing for protection. Once every 3 months during storage, carry out functional tests as described in the Technical Service Manual and ensure that the internal battery is fully charged. Caution : Before cleaning always switch OFF disconnect from the AC power supply. Never allow liquid to enter the casing and excess fluid build up on the pump. Do not steam autoclave, ethylene oxide sterilize or immerse this pump in any fluid. Keep the pump plugged into electrical power during storage. 31

Maintenance Replacing the AC fuses If the pump continually illuminates the battery indicator and the AC power indicator light does not illuminate when the pump is connected to the AC power supply and switched ON, suspect that either the power supply fuse in the AC plug or the internal fuses have blown. First check the power supply fuse in the AC mains plug. If the AC power indicator light does not illuminate remove the pump from service. It is recommended that only a qualified service engineer replaces the AC fuses. For further information regarding the replacement of internal AC fuses refer to the Technical Service Manual. 32

Maintenance Battery Operation The internal rechargeable battery allows continued operation when the AC power is unavailable, for example during patient transfer or AC power failure. A fully charged battery will provide over 4 hours of operation at typical infusion rates. A low battery alert is activated approximately 30 minutes before the battery depleted alarm. The battery is maintenance free, sealed Nickel Metal Hydride and requires no routine servicing. However, to achieve optimum operation, ensure that the battery is fully recharged after full discharge, before storage, and at regular 3 month intervals during storage. Charge retention will eventually degrade. Where retention is critical the internal battery should be replaced every 3 years. It is recommended that only a qualified service engineer replaces the Battery. For further information regarding the replacement of batteries refer to the Technical Service Manual. 33

ml Occlusion Level(psi) Occlusion Pressure Limits Time to alarm following occlusion is achieved in less than 5minutes at rates of 25ml/hr and higher by the appropriate selection of occlusion levels. The following graphs show the typical values for time to alarm and bolus volume that can be expected in the event of an occlusion when the IV-set (KV 243T) is selected. 16 14 12 10 8 6 4 2 0 Time to Alarm - 25ml/hr 0 1:00 2:00 3:00 4:00 min : sec 1.6 1.4 1.2 1 0.8 0.6 0.4 0.2 0 Bolus Volume 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 Occlusion Level(psi) 34

Start-up Curves & Trumpet Curves In this pump, as with all infusion systems, the action of the pumping mechanism and variations in individual IV-sets cause short-term fluctuations in rate accuracy. The following curves show typical performance of the system in two ways : 1) the delay in onset of fluid flow when infusion commences (start-up curves)... and 2) the accuracy of fluid delivery over various time periods is measured (trumpet curves). The start-up curves represent continuous flow versus operating time from the start of the infusion. They exhibit the delay in onset of delivery due to mechanical compliance and provide a visual representation of uniformity. Trumpet curves are derived from the second hour of this data. Tests performed per IEC60601-2-24 standard. 35

Start-up Curves & Trumpet Curves Trumpet curves are named for their characteristic shape. They display discrete data averaged over particular time periods or 'observation windows', not continuous data versus operating time. Over long observation windows, short term fluctuations have ㅣ little effect on accuracy as represented by the flat part of the curve. As the observation window is reduced, short term fluctuations have greater effects as represented by the "mouth" of the trumpet. Knowledge of system accuracy over various observation windows may be of interest when certain drugs are being administered. Short term fluctuations in rate accuracy may have impact depending on the half-life of the drug being infused, therefore the clinical effect cannot be determined from the trumpet curves alone. Caution : Start-up and trumpet curves may not be indicative of operation under negative pressure. 36

Error(%) Rate(ml/hr) Start-up Curves & Trumpet Curves 30 25 20 15 10 5 0 Start-up (25ml/hr) 17s 2m 5m 9m Time 13m 17m 31m Trumpet Curve (25ml/hr) 15.00% 10.00% 5.00% 0.00% -5.00% 17s 1m 5m 11m 19m 31m -10.00% -15.00% Observation Window(mins) 37

Warranty Woo Young Medical Co., Ltd. offers a 24-month warranty on every Accumate 2300 unit (except for the battery), effective from the date of delivery. The battery is free from defects in material and workmanship under normal use and service for a period one hundred eighty(180) days from the date of delivery by Woo Young Medical to the original purchaser. This includes the repair or replacement of damaged parts as a result of design/ manufacturing errors or material defects. This warranty do not apply if Accumate 2300 has been altered, misused, or repaired by persons not authorized by Woo Young Medical. The warranty do not cover the elimination of problems caused by incorrect operation, inappropriate handling normal wear and tear. 38

Service & Packaging Service If the pump fails to respond to the operating or troubleshooting procedures listed in this manual and the cause cannot be determined, discontinue use and forward it to an authorized Woo Young Medical's agency. With each complaint, please include pump serial number and full description of difficulty, including all setting, types of fluids, time, and alarm messages. Return IV-set used if possible. Woo Young Medical cannot assume responsibility for loss or damage to returned pumps while they are in transit. Packaging The pump packaging is reusable. Package Contents : Accumate 2300 Infusion Pump, power cable, operation manual 39