Belmont Medical Technologies HYPERTHERMIA PUMP Operator'S Manual Download Page 42

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Chapter 4: Parameters Setting, Service and Preventive Maintenance

4-10

Electrical Safety Test - Leakage Current

Equipment required: Fluke Safety Analyzer, Model 505 or equivalent

2 Liters of room temperature saline

Setup:

Plug the Hyperthermia Pump

™

into AC outlet on the panel

of the Safety Analyzer.

CAUTION:

Before applying voltage to Safety Analyzer, make sure input line
voltage is correct for the

VOLTAGE OF UNIT UNDER TEST

Earth Leakage Currents:

Plug the Safety Analyzer into an appropriate power source,
turn Analyzer power to ON. Hyperthermia Pump

™

power

switch to STANDBY.

ii.

Switch selector on Analyzer to CHASSIS or LEAKAGE (

A).

Connect a single red lead to the SINGLE LEAD input jack
and attach large clamp to equipotential ground terminal on
the Hyperthermia Pump

™

iii.

Record the leakage current displayed for each of the
following conditions, with Neutral switch in NORM position.
Tests should be performed in the following order.

Polarity - NORM;

Ground – NORM

Polarity - REVERSE; Ground – NORM

Polarity - REVERSE; Ground – OPEN

Polarity - NORM;

Ground - OPEN

iv.

Repeat the first two (Normal Polarity and Reverse Polarity -
Grounded) with Neutral switch in OPEN position.

Install the disposable set and prime with saline and proceed
to the Infuse screen. Press STOP to set the pump at 0
ml/min, not heating or pumping.

vi.

Repeat iii & iv with the Hyperthermia Pump

™

in ON mode

(power switch ON, infuse screen displayed, not pumping or
heating).

vii.

Repeat iii & iv with the Hyperthermia Pump

™

infusing and heating

at 750 ml/min.

Summary of Contents for HYPERTHERMIA PUMP

Page 1: ...OPERATOR S MANUAL HYPERTHERMIA PUMP ...

Page 2: ...HNICAL SUPPORT USA 855 397 4547 WORLDWIDE 1 978 663 0212 TECHSUPPORT BELMONTMEDTECH COM WWW BELMONTMEDTECH COM All service calls questions should be directed to USA 855 397 4547 Worldwide 1 978 663 0212 CAUTION Federal law USA restricts this device to sale by or on the order of a physician P N 705 00058 Rev Y ...

Page 3: ...voir with Straight Inflow Bifurcated Outflow 2 3 Inspect the System 4 4Liter Reservoir with two Inflow and two Outflow Patient Line Option 2 3 Installing the Disposable Set 2 4 Install 4 4 Liter Reservoir with Straight Inflow Outflow Patient Line 2 5 Install 4 4 Liter Reservoir with Straight Inflow Bifurcated Outflow Patient Line 2 6 Install 4 4 Liter Reservoir and the Straight Inflow Outflow with...

Page 4: ...em Error 201 Air Detector Fault 3 5 System Error 202 Fluid Out Detector Fault 3 5 System Error 203 Heater Fault Latch 3 5 System Error 204 Heater Power Read Back Fault 3 5 System Error 205 Heater Over Power Fault 3 5 System Error 206 Power Module Overtemp 3 5 System Error 207 Pump Fault 3 6 System Error 208 Valve Fault 3 6 System Error 209 Board Overheat 3 6 System Error 210 Internal Computer Malf...

Page 5: ...ng the System and Operational Check Out 4 8 1 Visual Inspection 4 8 2 System Operational Checkout 4 9 3 Electrical Safety Test Leakage Current 4 10 4 Hardware Verification 4 12 5 Clean the Pump Head 4 17 E Checklist 4 18 F Electromagnetic Compatibility 4 20 G Fuse 4 22 H Calling for Service 4 22 CHAPTER 5 TECHNICAL SPECIFICATIONS Dimensions 5 1 Portability 5 1 Power AC 5 1 Battery 5 1 Environmenta...

Page 6: ...ture patient temperature 4 locations line pressure alarm and status messages and proper procedures to proceed safely after an alarm situation Keys appropriate to a particular point in the operation are displayed on the touch screen A hardware override circuit prevents unsafe operation in case of system computer failure A vacuum regulator is provided to allow regulation of the fluid levels of the l...

Page 7: ...iability 4 Display and control panel show status and alarm messages with touch keys at the bottom of the screen 5 IR Temperature Probe Output Probe monitors output fluid temperature labeled as Tpump as it exits the Heat Exchanger Tpump is adjustable through the touch screen from 37º to 48ºC 6 Air Detector detects air in the line If air is detected the valve wand is closed immediately to prevent ai...

Page 8: ...ed Outflow Patient Line page 3 and Single Reservoir with two Inflow and two Outflow Patient Line page 2 Single Reservoir 4 4 Liter with Straight Inflow Straight Outflow Patient Line Single Reservoir 4 4 Liter with Straight Inflow Bifurcated Outflow Patient Line CONTROL PANEL DISPLAY AND KEYS The control panel consists of the touch screen display which incorporates a bright ...

Page 9: ...ºC Target Temperature in ºC Function Keys The keys that control all system functions are displayed on the screen The screen is changed each time a function key is pressed Only keys that are relevant to the desired function are presented The active key is highlighted There are three 3 different levels of sensitivity Fast Medium and Slow The key sensitivity is set at the factory to medium but can be...

Page 10: ... Reservoir with Straight Inflow Bifurcated Outflow Patient Line REF 902 00038 consists of 1 set Heat Exchanger REF 902 00006P 1 set 4 4 Liter Reservoir REF 902 00034P 1 set Straight Inflow Bifurcated Outflow Patient Line REF 902 00040P Disposable Set Kit for 4 4 Liter Reservoir with two Inflow and two Outflow Patient Line the Hyperthermia Pump Procedure Kit REF 902 00045 consists of 1 set Heat Exc...

Page 11: ...he presence of flammable anesthetics To avoid risk of electric shock this device must only be connected to a supply mains with protective earth Do not use with pressure infusers or bag squeezers The system pump provides adequate pressure to infuse fluid The Hyperthermia Pump is not for use in warming blood or blood components or blood products for the purpose of transfusion The Hyperthermia Pump h...

Page 12: ...nto the IV pole above the support clamp 2 Lift up on the Pole Clamp Release Handle to open Mount the system onto the IV pole just above the support assembly by pushing down on the pole clamp release handle Check that the system is locked in place before proceeding 3 Clamp the Reservoir Holder onto the IV pole approximately 9 above the Hyperthermia Pump 4 Clamp the Vacuum Trap Holder a few inches a...

Page 13: ...REF 902 00038 1 Power cord Use only the supplied power cord 4 External Temperature Interface Cables 1 Heat Exchanger REF 902 00006P 1 4 4 Liter Reservoir REF 902 00034P o 1 tubing with bag spike o 1 tubing with medication port o 1 Vacuum source tubing with filter 1 Patient Line Set REF 902 00040P contains o 1 8 ft Patient Line with straight inflow o 1 8 ft bifurcated outflow 1 Reservoir Holder REF...

Page 14: ...uid out detector 3 Guide the curved piece of pump tubing Blue tinted tubing over the pump head Check that the thinner Recirculate Line 3 16 O D tubing is in the groove to the right Do not kink or twist the tubing 4 Place the Pressure Chamber into the pressure chamber well Firmly insert the wider Perfusion Line 3 8 O D tubing into the air detector and to the left of valve wand Do not apply excessiv...

Page 15: ...r outlet 3 8 O D tubing and the Recirculation Line 3 16 O D tubing to the connectors of the Heat Exchanger 4 Adjust the Reservoir Holder to make sure that the two connection leads underneath the reservoir are not stretched or kinked Stretched or kinked connection leads can cause flow restrictions 5 Close all clamps and the ON OFF pinch clamps INSTALLING PATIENT RETURN LINE 1 Hand off the 16 ft Pat...

Page 16: ...e Recirculation Line 3 16 O D tubing to the connectors of the Heat Exchanger 4 Adjust the Reservoir Holder to make sure that the two connection leads underneath the reservoir are not stretched or kinked Stretched or kinked connection leads can cause flow restrictions 5 Close all clamps and the ON OFF pinch clamps INSTALLING PATIENT RETURN LINE 1 Hand 8 ft Patient Line and the 8 ft Bifurcated Patie...

Page 17: ... and the Recirculation Line 3 16 O D tubing to the connectors of the Heat Exchanger 4 Adjust the Reservoir Holder to make sure that the two connection leads underneath the reservoir are not stretched or kinked Stretched or kinked connection leads can cause flow restrictions 5 Close all clamps and the ON OFF pinch clamps INSTALLING PATIENT RETURN LINE 1 Hand off the Procedure Kit to the sterile fie...

Page 18: ...ppears on screen Check the power cord and AC receptacle connections if the statement does not appear If Agree is pressed the screen will display Password screen Enter a factory default password 111111 NOTE If Disagree is pressed Turn power off procedure ended will display If you want to change the password P W press Change P Word and enter the old P W Enter the new P W and then confirm the passwor...

Page 19: ...ersion 4 Drop sufficient volume to prime the entire system approximately 500 ml PRIME THE MAIN SYSTEM System Priming Screen CAUTION Immediately wipe any spills from the device 5 Press PRIME to recirculate 100 ml of fluid at 500 ml min to remove air and fill the main system with fluid The prime volume 100 ml countdown is displayed on the screen The pump will stop automatically when countdown reache...

Page 20: ...TERNAL TEMPERATURE PROBES PROBES ARE SUPPLIED WITH THE PROCEDURE PACK KIT REF 902 00045 IF YOU DO NOT USE THIS KIT REF 902 00045 MAKE SURE YOU HAVE PROBES IF NEEDED Accept external temperature connections from the sterile field and connect to the Hyperthermia Pump external temperature interface cables Connect temperature probes to the corresponding color jacks on the unit Push firmly to assure ful...

Page 21: ...TE RATE key 3 Adjust the output temperature from 37 to 48 C by pressing TARGET TEMP TARGET TEMP key to reach the specified output temperature The set temperature is displayed in both TARGET TEMP and TARGET TEMP keys The actual fluid temperature as it exits the heat exchanger Tpump is also displayed on screen The Target Temperature is increased decreased by 0 1 C every time key is depressed 4 Pump ...

Page 22: ...idly The minimum flow rate is 10 ml min 1000 ml min Press to set the system to pump at RATE 1000 ml min Tpump The actual fluid temperature as it exits the heat exchanger The desired output temperature can be set using TARGET TARGET key T1 Patient Temperature at location 1 T2 Patient Temperature at location 2 T3 Patient Temperature at location 3 T4 Patient Temperature at location 4 TARGET Press to ...

Page 23: ... to 500 ml min during automatic air purging If the flow rate is above 500 ml min the recirculate rate is at the actual flow rate When pumping resumes the system returns to the previously set flow rate END OF PROCEDURE CAUTION With fluid in the disposable set and the system not powered on keep the patient line clamped closed when opening the door to prevent uncontrolled fluid flow CAUTION If the po...

Page 24: ...y operation if the AC power is interrupted The system can operate in battery mode for a very short period of time The maximum flow rate is 50 ml min There is no heat in battery operation Audible alarm sounds every 10 seconds to alert user that the system is in battery operation and requires an intervention Press MUTE to silence the alarm All operating keys will not operate until MUTE key is presse...

Page 25: ...TOR ACTION AIR DETECTION Air Detection Alarm Message Screen Reprime Screen Air in the line Tubing in the air detection sensor is not seated firmly in the detector Leak in the disposable Air detector sensor dirty Air detector electronics defective Press MUTE to silence the alarm Check for air bubbles and possible leaks Squeeze the tubing directly below air detector to clear any trapped air out of t...

Page 26: ...r recirculate line is obstructed Vacuum source is set too high Detector electronics defective Press MUTE to silence the alarm If out of fluid add additional fluid and press REPRIME If the Reprime volume count does not count down from 100 to 0 ml then Check the bags are fully spiked and clamps are fully opened Check that the pump head tubing is not stretched and is seated firmly within the fluid ou...

Page 27: ...hat the flow path is not blocked Check that the recirculate line is not obstructed Check that the inflow cannula is not obstructed Increase pressure limit setting Press NEXT to silence the alarm and resume Check functionality of the pressure transducer by gently pressing the transducer Pressure reading on screen should change If not it is defective service machine MISSING DISPOSABLE Missing Dispos...

Page 28: ...wer off and service machine if error persists SYSTEM ERROR 102 INFUSATE OVER TEMPERATURE DISCARD DISPOSABLE AND BLOOD RESTART SYSTEM WITH A NEW DISPOSABLE SERVICE MACHINE IF ERROR PERSISTS Fluid supply is over the temperature limit Temperature probes are wet dirty or blocked Restricted flow or out of fluid Check disposable set and flow path for occlusions Make certain the windows on the disposable...

Page 29: ...sts SYSTEM ERROR 205 PRESS RETRY TO CONTINUE SERVICE MACHINE IF ERROR PERSISTS Heater hardware fault Press RETRY to try again Power off and restart Service machine if error persists SYSTEM ERROR 206 CHECK FOR BLOCKED AIR INTAKE WAIT FOR THE SYSEM TO COOL SERVICE MACHINE IF ERROR PERSISTS Power driver module overheating Make certain that the fan air vents at the bottom of the machine are not blocke...

Page 30: ...9 CHECK FOR BLOCKED AIR INTAKE WAIT FOR THE SYSEM TO COOL SERVICE MACHINE IF ERROR PERSISTS Printed Circuit Board overheating Make certain that the fan air vents at the bottom of the machine are not blocked Wait for unit to correct problem Display will return to Infuse screen when the error clears Press MUTE to silence the alarm Power off and restart Service machine if error persists SYSTEM ERROR ...

Page 31: ...in the line under the Pressure Limit by reducing the infusion rate Check and remove kinks or obstructions in the tubing Increase flow by increasing the Pressure Limit Change the Pressure Limit in Calibration Setup to a higher limit maximum Pressure Limit is 300 mmHg Chapter 4 page 40 Keypad does not accept input The keypad is being continually depressed Keypad failure Release the keypad and the co...

Page 32: ... up resulting in the roller pump hitting the door hub System does not heat to physiologic temperature Windows on the disposable or IR sensor is wet or dirty Power module is not calibrated properly Power module malfunction or temperature probes are out of calibration Examine the windows on the disposable set for wetness or contaminants Clean IR sensor window with soft cloth and alcohol if necessary...

Page 33: ...ers setting The instrument does not need regular calibration WARNING Practice standard precautions when handling any caustic solution Clean up all spills immediately WARNING Test leakage current routinely to insure against electrical shock hazard CAUTION Turn the system to STANDBY and unplug the power cord before cleaning to avoid electric shock CAUTION Immediately wipe any spills from the device ...

Page 34: ...etup changes are performed in the Service mode Pressing the SERVICE key accesses the Calibration Set up mode This key appears on the BELMONT logo screen only at system powered up This screen remains active for 4 5 seconds before the system enters the Prime mode CALIBRATION SET UP TIME 23 59 DATE 08 29 15 PRESS LIMIT 300mmHg DISPLAY BRIGHT LANG SETUP TEMP CAL PRESS CAL POWER CAL FAST KEYRATE PRESS ...

Page 35: ...umerical keypad will be displayed Enter the appropriate time or date information Enter the appropriate time in 24 hour clock format i e 1 00 PM 13 00 CANCEL will erase the entered value and return to the previous Date Time screen Press UPDATE to save the new value and return to the previous DATE TIME key screen Press NEXT to return to the Calibration Set Up screen Screen after pressing DATE Screen...

Page 36: ... key requires the most time and makes the touch keys least sensitive The key sensitivity is set at factory to Medium Note that this key changes the time required to depress a key for stroke to be recognized The pressure required is not affected 5 Pressure Limit The user can set the maximum allowable in line pressure The possible setting ranges from 100 to 300 mmHg The current pressure limit value ...

Page 37: ...Cord 4 Clean Temperature Probes 5 Check Clean the Fan Guard 6 Check Clean the Vacuum Trap 7 Check the System Seal 8 Check Instrument Door and Ceramic Disk 9 Check Rubber Feet Schedule 2 To be performed by either a BMET or other qualified service personnel Required Test Verification Interval Every 6 Months Every Year 1 Perform Visual Inspection 2 Perform System Operational Check Out including the A...

Page 38: ...an with a moistened Q tip and dry Air detector surfaces are delicate Use care when carrying out this procedure 3 Power Cord Inspect the power cord along its length and connectors for cuts and breaks Replace power cord if damaged 4 Temperature Probes Keep the probe sensors clean and dry If they become dirty or wet clean with a moistened Q tip and dry Use care not to damage the sensor surface 5 Fan ...

Page 39: ...orrectly The platen part of the roller pump is located on the door The platen must line up properly with the pump a Check hinges for debris build up clean any dried debris fluid from hinges area Be sure that door is seated completely down on the hinges b Check plastic rivets and door integrity Make sure that the doorframe is not bent Replace if bent c Inspect the ceramic disks on the door and in t...

Page 40: ...tic push pins on the door are in place iii Check that the valve pincher set screw is tight iv Check that there are no cracks in the ferrite on either the door or the right hand side v Check that the pressure transducer diaphragm has no tears or rips vi Check that each pump roller spins freely If not remove and clean vii Check that the door is pushed all the way down and there is no dried debris or...

Page 41: ...s RATE to change flow rate Set the Target Temperature to 38 C g Increase flow rate to 500 ml min and verify that the output temperature on the display is 38 1 C h Remove the power cord Verify that the system automatically switches to battery when AC is disconnected BATTERY NO HEATING message displays to indicate the system is now in battery mode and heating is suspended Verify that alarm sounds ev...

Page 42: ...e red lead to the SINGLE LEAD input jack and attach large clamp to equipotential ground terminal on the Hyperthermia Pump iii Record the leakage current displayed for each of the following conditions with Neutral switch in NORM position Tests should be performed in the following order Polarity NORM Ground NORM Polarity REVERSE Ground NORM Polarity REVERSE Ground OPEN Polarity NORM Ground OPEN iv R...

Page 43: ...e clamp to the cannula or needle tip iii Prime the Hyperthermia Pump with saline Make sure that the entire patient line including the cannula has been primed iv Repeat a iii and a iv with the Hyperthermia Pump in the STANDBY ON and pumping at 750 ml min modes v Maximum leakage allowable is as follows With NORMAL NEUTRAL Normal Polarity Grounded 10 μA Reverse Polarity Grounded 10 μA Reverse Polarit...

Page 44: ...peed e Input and Output Temperature Probes and f Pressure sensor A password is required to access the SERVICE screen to ensure that this mode is not accessed accidentally Press the SERVICE key at power up to access the Calibration Set up screen This screen remains active for 4 5 seconds before the system enters the Prime mode screen WARNING Do not access hardware verification while the instrument ...

Page 45: ...ressure Pressure in mmHg Fluid Out Detector Status Air or Fluid Air Detector Status Air or Fluid Battery Voltage Battery charge level in volts Board Temperature Temperature of the circuit board inside the case Function Key Action PUMP SPEED Change pump speed LEFT VALVE Move the valve to the left or recirculate position OPEN VALVE Move the valve to the middle or load position RIGHT VALVE Move the v...

Page 46: ...all outlet Battery voltage displayed in HARDWARE screen should be approximately 24 volts If not recharge the battery for at least 8 hours and recheck Plug the unit back into the wall outlet d Flow Rate The flow rate can be verified by actually measuring the flow using a graduated cylinder and timer or by using a tachometer Choose the method that best serves your setup Directly measure the flow i M...

Page 47: ... speed to 500 ml min and repeat the measurement The accepted tolerance is 97rpm 10 e Input and Output Temperature Probes Prepare at least 2 liters of 37 43 C fluid i Connect the fluid supply to the disposable Remove the patient line from the luer connector Insert the thermocouple approximately 2 into the connector previously connected to the patient line ii Press the RIGHT VALVE key to set the val...

Page 48: ...talled see Chapter 2 Installing the Disposable and the flow path is not blocked iii Make certain the fluid is warm 37 C 42 C The pressure chamber of the disposable is less compliant when it is at room temperature Verification must be performed with a warm disposable iv In the Hardware mode close the door the bag clamps and block the air vent on top of the reservoir chamber Disconnect the patient l...

Page 49: ...ew the retaining screw that holds the pump head c Remove the pump head and clean with water and soap Hydrogen peroxide or a mild bleach solution can be used to disinfect d Let pump head dry before replacing and make certain the pump head is securely fastened with the retaining screw e If the pump head squeaks spray the roller with Silicone spray Heavy Duty Pure Silicone Retaining Screw Roller Pump...

Page 50: ...b Back c Latch Unlatch if OK 2 Operational Check Out d PRIME e PT LINE PRIME f INFUSE g Output Temperature 500 ml min h AC to DC switch over i DC to AC switch j Vacuum regulator if OK 3 Electrical Safety Check See attached Results Sheet a Earth Leakage Current b Patient Leakage Current if OK 4 Hardware verification a Valve Operation b Fluid Out and Air Detectors c Battery Voltage d Flow Rate e Inp...

Page 51: ...y N Ground O Unit in STANDBY Neutral NORM Neutral OPEN Unit in ON not pumping Neutral NORM Neutral OPEN Unit in ON infusing 750 ml min Neutral NORM Neutral OPEN b Patient Leakage Currents all measurements are in μA Polarity N Ground N Polarity R Ground N Polarity R Ground O Polarity N Ground O Unit in STANDBY Neutral NORM Neutral OPEN Unit in ON not pumping Neutral NORM Neutral OPEN Unit in ON inf...

Page 52: ... with other equipment and that if adjacent or stacked use is necessary the equipment or system should be observed to verify normal operation in the configuration in which it will be used NOTE The EMC tables and other guidelines that are included in the Instruction Manual provide information to the customer or user that is essential in determining the suitability of the Equipment or System for the ...

Page 53: ...or ceramic tile If floors are synthetic the relative humidity should be at least 30 Radiated RF IEC 61000 4 3 3 V m 3 V m Radiated RF frequency is negligible at any single frequency Electrical Fast Transient burst IEC 61000 4 4 2kV on AC Mains 2kV on AC Mains Mains power quality should be that of a typical commercial or hospital environment Surge IEC 61000 4 5 1kV Differential 2kV Common 1kV Diffe...

Page 54: ...ting 5x20mm with interrupting rating breaking capacity of 35A 250VAC H CALL FOR SERVICE USA 855 397 4547 Worldwide 1 978 663 0212 Prior to returning any product please obtain a Return Merchandise Authorization RMA number Before calling please have the serial number of the unit The serial number is located on the label above the power receptacle ...

Page 55: ...ted Fuse 1 25A 250V Fast Acting 5 x 20mm with interrupting rating breaking capacity of 35A 250VAC Operating Frequency 50 60 Hz Maximum Power 1440 VA Line Isolation 1500 V to ground Earth Leakage Current 300 μA For Domestic unit 500 μA For 230 V unit Electrical Compliance EN 60601 1 CSA C22 2 No 601 1 M90 Circuit Breaker 15Amp 125VAC 250VAC 50 60 Hz Power Cord U S 3 conductors 14 AWG type SJT Cord ...

Page 56: ...to 48o C Heating Capacity Min 1400 watts to fluid 20o C temperature rise at 1000 ml min Line Pressure 0 300 mmHg via pressure transducer OPERATING PANEL Control Panel and Display Splash proof touch screen display Display Area Diagonal screen 5 7 14 5 cm Status Display Flow rate ml min Total volume infused ml Line pressure mmHg Output fluid temperature Tpump o C Patient temperature location 1 T1 o ...

Page 57: ...ath The fluid detector is mounted closest the fluid bag It sounds an alarm if there is no fluid entering the system The other air detector checks for air in the fluid line before it enters the patient line Out of Fluid criterion Detect 0 8 ml air in input line Air detection criterion Detect 0 1 ml air in fluid line Valve Wand Provides flow path to patient or recirculation fluid path within the sys...

Page 58: ...able delivered sterile with pyrogen free flow path for single use only Degree of Safety in Presence of Flammable Anesthetics Not suitable Mode of Operation Continuous Medical Equipment UL 60601 1 CAN CSA C22 2 No 601 1 ANSI AAMI ES60601 1 2005 R 2012 CAN CSA C22 2 No 60601 1 14 Medical General Medical Equipment As to electrical shock fire and mechanical hazards only in accordance with UL 60601 1 C...

Page 59: ...edical Device Directive 93 42 EEC and 2011 65 EU Alternating current Equipotentiality Standby ON Caution or Consult accompanying documents refer to manual Defibrillator proof type CF equipment IPX2 Protected against dripping water SN Serial Number Manufactured by Authorized European Representative ...

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