WORLD OF MEDICINE A127 Instructions For Use Manual Download Page 56

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Appendix

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Appendix

15.1

Test log

Date

Result

Comment

Signature

Summary of Contents for A127

Page 1: ...A127 Pump for Arthroscopy A127 Instructions for Use en...

Page 2: ...ly or in part without the approval of W O M WORLD OF MEDICINE GmbH We reserve the right to technical changes without prior notification due to the continuous further development of our products Functi...

Page 3: ...ection provided by enclosures IP Code Protective earth Ground Alternating current Service Service Catalogue number Batch code Serial number Do not reuse Do not resterilize Sterilized using ethylene ox...

Page 4: ...c pressure limita tion Do not use if package is damaged Waste management Transport conditions Storage conditions Recyclable packaging Greendot symbol Recycling PAP PE RFID tag general Non ionizing ele...

Page 5: ...Setting Nominal Values 29 5 10 Starting the Device 29 5 11 Using the WASH Function 30 5 12 Switching the Device Off 30 6 Safety Functions 32 6 1 Device Self Test 32 6 2 Exceeding Nominal Pressure 32...

Page 6: ...vi 13 Technical Data 52 14 Error and Warning Messages 54 15 Appendix 56 15 1 Test log 56 Glossary 58 Index 60 en...

Page 7: ...right to modify the appearance graphics and tech nical data of the product through continued development of its products Please note Paragraphs marked with the words WARNING CAUTION and NOTE carry sp...

Page 8: ...e manufacturer s warranty Authorized service technicians are only trained and certified by the manufacturer Care and maintenance The service and maintenance of the device and its accessories has to be...

Page 9: ...the necessary training in arthroscopic procedures The product A127 is an irrigation pump for diagnostic and or surgical arthroscopic procedures Such procedures may include Ligament injuries Meniscus...

Page 10: ...d to inject medication The device is not designed or intended for use with gas 3 3 General Warnings and Precautions 3 3 1 General Warnings WARNING Risk of electrical shock To prevent electrical shock...

Page 11: ...gases and not in the vicinity of oxygen enriched environments WARNING Professional qualification The instructions for use do not include descriptions or instructions for surgical pro cedures techniqu...

Page 12: ...l Electrical System Use only parts and or devices from ME systems see Chapter Glossary in patient environments in compliance with the standard IEC60601 1 in the respective cur rently valid version WAR...

Page 13: ...or death due to contamination and or impaired functionality of the product Do not reprocess the product WARNING Falls and crashes Place the device on a stable and level surface Cables must be laid sa...

Page 14: ...other devices or instruments was practically eliminated However if you still detect or suspect such interference please follow these suggestions Move this the other or both devices to a different loca...

Page 15: ...N Mains Power Cable Any power cables employed by the user that are not provided by the manufacturer must meet the safety requirements of the national standards in the respective cur rent valid version...

Page 16: ...m the joint Please refer to the descriptions of various warnings described in these Instructions for Use WARNING Loss of distension Distension may be lost when resetting the nominal flow or nominal pr...

Page 17: ...gery to prevent infections Check all the single use disposable items before removing them from the package to ensure that the packaging is intact and that the expiration date is still valid Returning...

Page 18: ...essories WARNING ME System Medical Electrical System Use only parts and or devices from ME systems see Chapter Glossary in patient environments in compliance with the standard IEC60601 1 in the respec...

Page 19: ...of 50 to operate the device up to 2 m 6 5 ft from the device front for monitoring the actual values CAUTION To avoid malfunctions The device A127 should not be used directly next to other devices as...

Page 20: ...nly use a certified UL listed removable mains connection cable type SJT min imal 18 AWG 3 leads The plug connectors must comply with NEMA 5 15 and IEC 60320 C13 Grounding will only be reliable if the...

Page 21: ...urely in place Also check that the toggle screw remains tightened 1 Position the pump on the rod of the stand at the desired height usually between 80 and 120 cm example Base of stand 65 cm maximum he...

Page 22: ...Remote operation interface 5 Operating states and warnings display 6 Service LED 7 Overpressure LED 8 WASH operating mode LED 9 WASH key 10 Increase pressure key PLUS 11 Decrease pressure key MINUS 12...

Page 23: ...e the tube set is removed If the device check is unsuccessful the corresponding error messages are displayed on the Operating States and Warnings display ERROR see Chapter Error and Warning Messages 5...

Page 24: ...hno logy All irrigation tube sets are equipped with a transponder The transponder techno logy detects the tube type the validity and reliability of a tube set automatically and a corresponding message...

Page 25: ...he pump can be started stopped as often as desired with a tube set in validated during the current application if the tube set is not removed Once the tube set is removed during the last remaining cyc...

Page 26: ...ument tube 10 Luer lock connector The irrigation tube set consists of three tube sections roller tube inflow tube and instrument tube a Y connector 2 spikes with protective caps 2 tube clamps and a pr...

Page 27: ...he package Connecting the instrument 2 To be carried out by sterile technician Keep the Luer lock connector 10 in the sterile area and hand the tube end with the spikes 2 to the non sterile technician...

Page 28: ...break With rigid containers fluid cannot flow quickly enough due to the vacuum being generated inside of the containers Risk of implo sion with rigid containers The fluid bags must be suspended at a h...

Page 29: ...set has been inserted and the irrigation fluid bags are connected tap the START STOP key 2 see Fig Front of the device 22 to start the pump The START 3 operating mode LED lights up green If the attem...

Page 30: ...the tube with fluid 5 The pump detects when the tube is filled The device starts the instrument re cognition process automatically as soon as pressure conditions have stabilized This may take from a f...

Page 31: ...Operating the Device 31 62 NOTE Safe disconnection from power supply A safe and all pole disconnection of the product from the power supply is only en sured by disconnecting the power cord en...

Page 32: ...heel to reduce the overpres sure A visual or acoustic warning is not provided If the pump is unable to reduce the overpressure the Overpressure LED flashes red Fig Front of the device 22 7 and an acou...

Page 33: ...d reusable tubes sets NOT FOR SALE IN USA be fore surgery to prevent infections Check all the single use disposable items before removing them from the package to ensure that the packaging is intact a...

Page 34: ...ponding key on the remote control The pressure increase for the WASH func tion in this case 150 mmHg is depicted in the nominal pressure display The roller wheel must pump briefly and then stops 2 St...

Page 35: ...g Front of the device 22 3 lights up Wait until the instrument recognition is finished the instrument is outside of the joint and at a working height of 10 cm of the operation height 4 Close the inflo...

Page 36: ...Using the Device during Surgery 36 62 NOTE Disposal Comply with hygiene rules and regulations when disposing of the tube set collec ted fluid and the suction container en...

Page 37: ...he device at appropri ate intervals to ensure its safety and functionality The service interval is two years If the service interval is not maintained the manufacturer does not assume any li ability f...

Page 38: ...on your equipment do not light up the device does not function Check to make sure the main power supply cable is properly connected to the power supply input and to a safety socket the house power su...

Page 39: ...our country as well as the hygiene rules of the physician s office or hospital This ap plies in particular to the differing requirements regarding effective prion deactiva tion Products for cleaning a...

Page 40: ...brane removal Pretreatment Visual inspection If necessary post driying Reinstalling the membrane Packaging Sterilization Storage Manual reprocessing Manual cleaning Membrane removal Pretreatment Manua...

Page 41: ...er minimum volume 100 ml 4 Place the tube set and membrane in a freshly prepared cleaning solution Ob serve relevant requirements as listed in Chapter General Notes 39 concern ing the selection concen...

Page 42: ...rms ml and low endotoxin max 0 25 en dotoxin units ml water e g purified water high purity water is used for rins ing The air used for drying is filtered oil free low in particles and germs The washer...

Page 43: ...e membrane see Chapter Visual Inspection 43 Manual disinfection Instruction 1 Place the cleaned and inspected tube set and the membrane in the disinfection bath for the specified exposure time so that...

Page 44: ...eam sterilizer according to EN 13060 and EN 285 ANSI AAMI ST79 Validated according to EN ISO 17665 1 valid commissioning installation op erational qualification IQ OQ and product specific performance...

Page 45: ...RNING Signs of damage Please check the reusable tube NOT FOR SALE IN USA for signs of damage after sterilization and before use Never use a tube showing signs of damage especially brittleness and perf...

Page 46: ...ce if the specified measured values and tolerances are exceeded during the individual tests 10 1 Electrical Safety Test 1 Perform a visual inspection Make sure that the fuse corresponds with the speci...

Page 47: ...ements are functioning properly Preparing the pressure measuring test 1 Insert a test tube set into the device without connected instrument 2 Connect the tube set with a fluid bag 3 If necessary open...

Page 48: ...be set Luer lock connector and spikes only inflow T0449 01 Reusable tube set Luer lock connector and spikes only inflow NOT FOR SALE IN USA T0454 01 Power cable 2 0 m EU Z0101 01 Power cable 2 5 m US...

Page 49: ...he limits used in testing provide a basic level of safety against typical electromagnetic interference likely to occur in professional health care facilities Nevertheless it can happen that indi vidua...

Page 50: ...usiness or hos pital environment Blackouts brownouts and fluctuations of the power supply according to IEC 61000 4 11 0 UT 0 5 cycle At 0 45 90 135 180 225 270 and 315 0 UT 0 5 cycle At 0 45 90 135 18...

Page 51: ...70 Bluetooth WLAN 802 11 b g n RFID 2450 LTE Band 7 Pulse modu lation 217 Hz 2 0 3 28 5240 5100 5800 WLAN WLAN 802 11 a n Pulse modu lation 217 Hz 0 2 0 3 9 5500 5785 WARNING Portable HF communication...

Page 52: ...13 to 158 Relative air humidity 10 to 95 Air pressure kPa 70 to 106 Storage conditions Temperature C F 25 to 70 13 to 158 Relative air humidity 10 to 95 Air pressure kPa 70 to 106 Maximum sound level...

Page 53: ...ice interface 9 pin D sub port Mains power connection IEC 60320 1 C14 RFID transponder technology Transmit Receive Frequency Range 13 56 MHz 0 424 MHz Transceiver class Class I RF Output Power 10 83 d...

Page 54: ...ion pre vails until remedied High Critical safety threshold for pressure 250 mmHg exceeded OR Reversing the roller wheel did not reduce the overpressure Technical warnings user error Optical Acoustic...

Page 55: ...l Acoustic Priority Cause E50 service icon red constant 5 beeps High Communication error E55 service icon red constant 5 beeps High Electronics error E58 service icon red constant 5 beeps High Keyboar...

Page 56: ...Appendix 56 62 15 Appendix 15 1 Test log Date Result Comment Signature en...

Page 57: ...s form when returning the device Name of owner Sales partner Address of person returning unit Street House number ZIP Postal code City Country IMPORTANT Serial number see identification plate Device t...

Page 58: ...he respective device is fully functional ME Device Medical electrical device used for therapy monitoring or diagnosis of patients equipped with no more than one con nection to a supply network and whi...

Page 59: ...the device 23 Fig 5 4 Tube set elements 26 Fig 5 5 Inserting tube set 27 Fig 5 6 Position roller tube 28 Fig 5 7 Hanging fluid bags 29 Fig 8 1 Before surgery 35 Fig 9 1 Opening the fuse holder 38 Fig...

Page 60: ...alues and tolerances 46 O Only for U S operators 20 Open outer packaging 27 Open sterile autoclavable container 27 P Patient population 9 Performing the basic function test 47 Performing the pressure...

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