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WORLD OF MEDICINE A127, Инструкция по эксплуатации

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General Information

12 / 62

WARNING!

Contamination

Do not use device and/or accessories if signs of contamination are detected. Make
sure the device or/and accessories can no longer be operated until a qualified ser-
vice technician conducts the appropriate tests and repairs.

WARNING!

Condensation / Water penetration

Protect device from moisture. Do not use if moisture has penetrated the device.

WARNING!

Replace the fuse

Replace the fuse only with a fuse of the same type and rating (see Chapter Tech-
nical Data [

}

 52]).

WARNING!

Touching patient and device

The operating team must not touch both patient and device while the patient is in
sterile area and device is in non sterile area of the operating theatre.

WARNING!

Touching patient and device

Do not touch patient and the Standby/ON key at the same time.

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  respective  cur-
rently valid version.

WARNING!

ME System (Medical Electrical System)

Connect only items that have been specified as part of the ME system or specified
as being compatible with ME system.

WARNING!

Additional equipment

Additional  equipment  connected  to  medical  electrical  devices  must  be  demon-
strated  to  be  compliant  with  their  respective  IEC  or  ISO  standards  (IEC  60601-1,
IEC 60950 or IEC 62368 for data processing equipment). Furthermore, all configura-
tions must comply with the normative requirements for medical systems (see sec-
tion  16  of  the  last  valid  edition  of  IEC  60601-1).  Anyone  who  connects  additional
devices to medical electrical equipment is a system configurator and as such is re-
sponsible  for  the  system's  compliance  with  the  normative  requirements  for  sys-
tems. Please contact the technical service if you have additional questions.

en

Содержание A127

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

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

Страница 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...

Страница 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...

Страница 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...

Страница 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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