Delfi 9-2100-001, Operator And Maintenance Manual

Page 1: ...TEM PRESSURE DEFLATE INFLATE TIME P T S REF 9 2100 001 U S PATENTS 6 213 939 5 931 853 5 649 954 4 469 099 PAT PEND and FOREIGN PATENTS Delfimedical innovations inc Delfi Medical Innovations Inc Vancouver BC Canada 800 933 3022 US Canada 604 742 0600 Global Fax 604 742 3800 www delfimedical com ...

Page 2: ...NESS FOR A PARTICULAR PURPOSE LIMITATION OF REMEDIES In no case shall Delfi Medical Innovations Inc be liable for any special incidental or consequential damages whether based on breach of warranty or other legal theory Some states do not allow limitations on warranties or on remedies for breach in certain transactions In such states the limits in this paragraph and the preceding paragraph do not ...

Page 3: ...CK 11 2 6 PRESSURE AND TIME DEFAULTS 11 2 7 OPERATION 11 2 8 ALARM CONDITIONS 13 2 8 1 ALARM SILENCE FUNCTIONS 17 2 8 2 INTERNAL HARDWARE FAILURES 17 2 8 3 PRESSURE HIGH or LOW ALARMS 17 2 8 4 LEAK ALARMS 17 SECTION 3 0 P T S MAINTENANCE INSTRUCTIONS 18 3 1 GENERAL MAINTENANCE INFORMATION 18 3 2 PERIODIC MAINTENANCE 18 3 2 1 CLEANING 18 3 2 2 INSPECTION 18 3 2 3 FUNCTIONAL AND CALIBRATION CHECKS 1...

Page 4: ...t traumatic lengthy hand reconstruction Severe crushing injuries Diabetes mellitus Severe hypertension Elbow surgery where there is concomitant excess swelling Skin grafts in which all bleeding points must be readily distinguished Compromised vascular circulation e g peripheral artery disease Sickle cell disease or trait relative contraindication see PRECAUTIONS IN USE Secondary or delayed procedu...

Page 5: ... the fibers may become embedded in the contact closures and reduce their effectiveness Follow the cuff manufacturer s recommendations for limb protection material under the cuff In general a limb protection sleeve designed specifically for the cuff provides the best protection If skin preparations are used preoperatively they should not be allowed to flow nor collect under the cuff where they may ...

Page 6: ... cuff applied to a 30 inch thigh inflates to 350 mmHg in less than 20 seconds Deflation Rate 34 inch cuff applied to a 30 inch thigh deflates to less than 10 mmHg in less than 25 seconds 2 1 3 SIZE Height 240 mm 9 45 inches Width 116 mm 4 57 inches Depth 50 mm 1 97 inches Weight 500 g 17 5 oz 2 1 4 ENVIRONMENTAL Operating temperature 10 to 40 C 15 to 105 F Storage temperature 20 to 40 C 4 to 105 F...

Page 7: ...for 2 seconds then revert to the current tourniquet elapsed time If the TIME button is held in for more than 1 second the unit advances the time limit set point first by 5 minute then by 10 minute increments 5 TIME Button Displays and decreases the time limit set point as described above for the TIME button 6 INFLATE Button Inflates the cuff to the pressure set point and starts the elapsed time mo...

Page 8: ...the hose connector The hose connector is a positive locking type that makes an audible click when properly connected 14 Hose Assembly One hose assembly is supplied with each P T S unit The male positive locking connector plugs in to the hose connector on the P T S unit see above The female end attaches to the tourniquet cuff The P T S is designed tested and recommended for use with Delfi and other...

Page 9: ...7 Figure 2 1 P T S Controls Indicators Displays and Connectors 16 14 PORTABLE TOURNIQUET SYSTEM PRESSURE 2 15 17 3 10 5 4 6 11 13 12 7 1 9 DEFLATE INFLATE TIME P T S 8 ...

Page 10: ...8 Figure 2 2 P T S Pressure and Time Display Detail Figure 2 3 P T S Message Display Detail ...

Page 11: ...ults explained in the following steps exactly as indicated Failure to do so indicates that a problem may exist and the device is not to be used until necessary repair or calibration has been made 2 5 1 AC POWER CONNECTION AND INDICATOR Connect the AC power plug to a properly polarized and grounded power source with voltage and frequency characteristics compatible with the specifications listed in ...

Page 12: ...to 0 NOTE Anytime a trailing asterisk appears the data being displayed is the set point Set pressure and time will revert to the default pressure and time when the unit is powered off and powered up again 2 5 5 CALIBRATION CHECK NOTE Every P T S unit is calibrated at the factory before shipping The unit also self tests specific calibration parameters upon power up Should a potential out of calibra...

Page 13: ...the pressure and time set points appear with trailing asterisk symbols in the pressure and time displays to indicate that the new default values have been stored d After about 2 seconds the unit resumes normal operation e The new default set point values will now be present every time the machine is turned on 2 7 OPERATION NOTE The P T S unit should be powered up at least once each day of use to e...

Page 14: ...mately to 1 in 2 5 cm from the edge of the tourniquet cuff The elastic bandage is removed following inflation of the cuff If regional anesthesia is being used the anesthetic agent or nerve block is then administered The surgeon will determine When the tourniquet is to be inflated What pressure is applied How long the tourniquet is applied Whether to allow for intermittent aeration of tissue by def...

Page 15: ...ore than 1 second PRESSURE HIGH Constant Current cuff pressure flashing Normal Momentarily Press PRESSURE PRESSURE TIME or TIME Press and hold PRESSURE to adjust set pressure to within 15mmHg of sensed pressure OR Press and hold DEFLATE for 2 seconds to deflate the cuff Alarm will stop automatically whenever the unit can regulate the cuff to within 15 mmHg of the pressure set point Low Pressure be...

Page 16: ... symbol Cycle 1s on 10s off Normal Normal Momentarily Press PRESSURE PRESSURE TIME or TIME Plug in AC power OR Press ON STANDBY to shut unit down Battery Low stage 2 The battery voltage has dropped to a level indicating that the unit may trigger a BATT ERROR alarm see below and shut down at any time BATT LOW 1 segment darkened in battery indicator symbol Constant Normal Normal Momentarily Press PR...

Page 17: ... up The unit has detected an approximate pressure of 50mmHg or more in the cuff when the unit was powered up The unit assumes a procedure is in progress changes the pressure set point to the detected pressure immediately regulates the cuff to this pressure and activates alarm to alert the user of the condition PRESSURE Constant Current cuff pressure flashing Normal Momentarily Press TIME or TIME M...

Page 18: ...Press and hold DEFLATE for 2 seconds to deflate the cuff Calibration failure The unit has detected that the calibration in the pressure transducer is invalid The unit has shut down in a safe state See also Calibration Procedure Section 3 3 ERROR Constant CAL Err None Disconnect the hose and press ON STANDBY twice to shut unit down and restart OR Calibrate the unit per Section 3 3 Internal electron...

Page 19: ... S unit and connect a replacement unit d If cuff deflation is required disconnect the cuff from the P T S unit WARNING In all cases of internal hardware failure erratic operation or unintelligible displays it is possible that the pressure in the cuff is not accurately displayed on the P T S unit and that cuff pressure may be present even when the P T S unit appears to be shut down The user must im...

Page 20: ...ergent solution or alcohol Tourniquet cuffs should be cleaned in accordance with the manufacturer s instructions CAUTION Do not attempt to clean or flush out the interior of the hose assembly Do not allow fluids or debris to enter the hose connectors on the P T S unit or the hose assembly CAUTION Avoid exposing the AC power supply to liquids Do not immerse in fluid Do not allow the AC power supply...

Page 21: ...rom the sensed pressure the unit shows CAL and Err messages in the pressure and time displays respectively and halts the calibration routine If this happens power off the unit and start over d Repeat the preceding step for reference pressures of 250 1 mmHg and 475 1 mmHg The unit will not allow calibration points to be skipped e Remove the reference pressure source and press the TIME button three ...

Page 22: ...attery alarm conditions see Table 2 1 progressively indicate decreasing battery capacity and need for recharging 3 5 1 BATTERY TESTING To determine if the battery pack needs replacement charge it for at least 8 hours and then test as follows a Remove the AC power supply and power up the P T S unit The battery indicator symbol should be visible in the message display and all 6 segments in the batte...

Page 23: ...ontact Delfi Cuff does not inflate Internal hardware failure Contact Delfi Cuff does not deflate DEFLATE button not held for 2 seconds Hose kinked or blocked Internal hardware failure Press and hold the DEFLATE button for at least 2 seconds Unkink hose or disconnect cuff from hose Ensure complete cuff deflation to clear CUFF NOT DEFLATED alarms Contact Delfi Green AC indicator light does not illum...

Page 24: ...Section 3 4 above Disconnect P T S from cuff to deflate cuff if required Contact Delfi BATT ERROR alarm Fully discharged battery Battery pack disconnected Faulty or dead battery pack Connect to AC power and allow battery to recharge for 8 hours Remove battery cover and ensure battery pack is securely plugged in Replace battery pack see Section 3 5 above Battery does not charge when unit is plugged...

Page 25: ... of the European Community cTUVus Medical Equipment with respect to electrical shock fire and mechanical hazards and electromagnetic compatability only in accordance with CAN CSA C22 2 No 601 1 M90 and UL 2601 1 Authorized representative in the European Community Manufacturer name and adress Figure 3 1 Labels ATTENTION T HISUNITMUSTBECHARGED ATLEAST8 HOURSBEFOREINIT IALUSE CALIBRAT ION ORFUNCT ION...

Page 26: ...ancouver BC Canada 800 933 3022 US Canada 604 742 0600 Global Fax 604 742 3800 www delfimedical com 2003 Delfi Medical Innovations Inc Printed in Canada 4 2100 024 Rev 3 0197 EC Abatis Medical Technologies Limited Ballybrohan Killaloe County Claire Ireland Eire ...