Attachment 6. Risk Management Report

Attachment 6 AGE Automatic Wrist Blood Pressure Monitor Risk Management Report Page 1 of 15 Risk Management Report AGE Automatic Wrist Blood Pressure Monitor Document Reference NoQR NIBP W01 BO Issued DateJul 8 2012 Revised dateAug 24 2012 Edited byMr Wan Attachment 6 AGE Automatic Wrist Blood Pressure Monitor Risk Management Report Page 2 of 15 Table of Content 1 PREFACE 3 2 EVALUATION TEAM MEMBER QUALIFICATION 3 3 RISK MANAGEMENT PROCESS 3 4 ACCEPTANCE CRITERIA 3 5 DEVICE DESCRIPTION 5 5 1 Intended use 5 6 RISK ANALYSIS 6 6 1 Questionnaires according to ISO14971 Annex A 6 6 2 Possible hazards analysis according to ISO14971 Annex D 8 7 RISK EVALUATION AND CONTROL 13 8 POST PRODUCTION INFORMATION 15 9 RISK MANAGEMENT CONCLUSION 15 Attachment 6 AGE Automatic Wrist Blood Pressure Monitor Risk Management Report Page 3 of 15 1 Preface This document is Risk management report of AGE Automatic Wrist Blood Pressure Monitor In the report all possible harm and its cause have been assessed each harm severity degree and occurrence probability has been evaluated We ll have harm decrease measure when a certain harm level is inacceptable Meanwhile all the remaining harm after taking harm measure have been assessed all the remaining harm level have been changed to be acceptable Reference standards ItemDescription SafetyIEC 60601 1 EMCIEC 60601 1 2 PerformanceSP10 Quality SystemISO 13485 2003 Risk ManagementISO 14971 2000 Medical Device Harm Control Application to Medical Device 2 Evaluation team member qualification Members that take part in risk identification risk evaluation risk assessment and risk control NameTitle or Qualification Mr Wan Quality Department Director Mr LiEngineering Department Director Mr WangDevice application expert 3 Risk Management Process The risk management process will be conducted follow the company Risk Management procedure COP 710 01 4 Acceptance criteria Attachment 6 AGE Automatic Wrist Blood Pressure Monitor Risk Management Report Page 4 of 15 NOTE P1 is the probability of a hazardous situation occurring P2 is the probability of a hazardous situation leading to harm P P1 X P2 is the probability of harm occurring Risk Severity x Probability S X P1 XP2 According to the definitions a hazard cannot result in harm until such time as a sequence of events or other circumstances including normal use lead to a hazardous situation The risk can be assessed by estimating both severity and probability of occurrence of harm that could result The severity of harm is classified in a number of classes NoSeverity Level 1NegligibleInconvenience or temporary discomfort 2MinorResult in temporary injury or impairment not requiring professional medical intervention 3SeriousResult in injury or impairment requiring professional medical intervention 4CriticalResult in permanent impairment or life threatening injury 5CatastrophicResult in patient death The probability of P1 and P2 is classified in a number of classes using 5 classes NoP1 Probability Level of a hazardous situation occurring NoP2 Probability of a hazardous situation leading to harm A 10 3a 10 3 B 10 2 10 3b 10 2 10 3 C 10 1 10 2c 10 1 10 2 Attachment 6 AGE Automatic Wrist Blood Pressure Monitor Risk Management Report Page 5 of 15 D 1 10 1d 1 10 1 E1e1 The probability of occurrence of harm will be different for the different causes The probability is classified in a number of classes using 5 classes NoP Probability Level of harm occurring 1Improbable 10 6 2Remote 10 5 10 6 3Occasional 10 4 10 5 4Probable 10 3 10 4 5Frequent 10 3 The acceptance criteria are as the table following Severity Probability1 Negligible2 Minor3 Serious4 Critical5 Catastrophic 5 FrequentALARPN ACCN ACCN ACCN ACC 4 ProbableALARPALARPALARPN ACCN ACC 3 OccasionalACCALARPALARPALARPN ACC 2 RemoteACCACCALARPALARPALARP 1 ImprobableACCACCACCACCACC N ACC not acceptable region ACC broadly acceptable region In between Risk as low as reasonably practicable ALARP RPN S X P1 X P2 S X P Result 1 6Acceptable 7 11ALARP 12 24Not acceptable 5 Device description 5 1 Intended use Automatic Wrist Blood Pressure Monitor is intended for use by medical professionals or at home to monitor and display diastolic systolic blood pressure and pulse rate on adult each time with an air cuff buckled around one s wrist according to the instruction in the user s guide manual Attachment 6 AGE Automatic Wrist Blood Pressure Monitor Risk Management Report Page 6 of 15 5 2 Device appearance Please refer to user s manual 5 3 Users manual Please refer to user s manual 6 Risk analysis 6 1 Questionnaires according to ISO14971 Annex A 6 1 1 What is the intended use intended purpose and how is the medical device to be used Automatic Wrist Blood Pressure Monitor is for use by medical professionals or at home and is a non invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual by using a non invasive technique in which an inflatable cuff is wrapped around the wrist 6 1 2 If the Medical Device is intended to contact with patient or other people Yes 6 1 3 Which material and component is included in Medical Device or accompanying with or contact with Medical Device The product has no contact with other device 6 1 4 Is there any energy be given to patient or obtained from patient The product gives a pressure to patient 6 1 4 If there is substance provided to patient or obtained from patient The product has no substance provided to patient The product doesn t obtained substance from patient 6 1 5 If biologic material is dealt by medical device and then reuse The product doesn t deal biologic material 6 1 6 If medical device is provided by sterile means or is intended to be sterilized by user or by other microbe control means The product isn t provided by sterile means The product isn t intended to sterilize by user 6 1 7 If medical device is expected to be cleaned and sterilized by user regularly The product is not expected to clean and sterilize by user regularly 6 1 8 If medical device is expected to improve patient s environment The product don t improve patient s environment 6 1 9 If medical device measure human body temperature No 6 1 10 If medical device have analysis procedure The product measure blood pressure and pulse and display it automatically 6 1 11 Is the medical device interpretative Yes there is a use manual 6 1 12 If medical device is expected to be used with medicine or other medical technology Attachment 6 AGE Automatic Wrist Blood Pressure Monitor Risk Management Report Page 7 of 15 The product doesn t need to be used with medicine or other medical technology 6 1 13 Are there unwanted outputs of energy or substances The product has no undesired energy or substance output 6 1 14 If medical device is sensitive to environment impact No 6 1 15 If medical device can influence environment The product maximum power is 75mw it can t influence temperature 6 1 16 If medical device have essential consuming product or accessory The product s consuming product is 5 dry battery two pieces of AA battery 6 1 17 If it need maintenance and calibration The product generally doesn t need maintenance and calibration under specific environment and tested object it need whole offset adjustment 6 1 18 If medical device have software The product includes solidified software 6 1 19 If medical device have shelf life limit The product have shelf life limit it determined by storage environment 6 1 20 If there is deferred and or long term usage effect The product has long term usage effect 6 1 21 Which mechanical force are endured by medical device Pressure 6 1 22 What determines medical device s shelf life The product s shelf life is determined by bump 6 1 23 If medical device is intended to be one off use The product isn t one off use product 6 1 24 If medical device need safe exit or disposal function The product has time deferred automatically switch off function no need safe exit function no need any treatment 6 1 25 If it need special training for the installation and use of medical device The product don t need installation user don t need special training only operate according to instruction manual 6 1 26 If there is need for establish and introduce new production process The product doesn t need establish and introduce new production process 6 1 27 If the successful use of medical device is determined by man made factor such as user s interface 6 1 27 1 If medical device have connection part and accessory The product has no connection part and accessory 6 1 27 2 If medical device have controlling interface The product has function setting key LCD panel but these interface integrated with device has no outer interface 6 1 27 3 If medical device display information The product displays information through LCD 6 1 27 4 If medical device is controlled by menu The product has function operating key menu The function menu displayed by LCD channel user Attachment 6 AGE Automatic Wrist Blood Pressure Monitor Risk Management Report Page 8 of 15 operating only when setting adjustment is needed It needn t menu control operation under normal use 6 1 28 If medical device is intended to be movable or portable The product is movable and portable 6 2 Possible hazards analysis according to ISO14971 Annex D 6 2 1 Energy hazards and contributory factors Energy hazards Evaluation electricityThe device uses 2 AAA batteries Device will not conduct shock or electricity hazard heatThe device uses 2 AAA batteries Device will not bring heat hazard mechanical forceThe device will not bring mechanical force ionizing radiationThe device has no radiation The device will not bring ionizing radiation non ionizing radiationThe device has no radiation The device will not bring ionizing radiation moving partsThe device has no moving parts unintended motionThe device could be restart the soft and clear all the mistake operation suspended massesThe device has no suspended masses failure of patient support deviceThe device could be restart the soft and clear all the mistake operation pressure e g vessel rupture The device will give pressure to patient over pressure may hurt patient acoustic pressureThe device can phonate Beep warning voice however the noise is no more than 80 db vibrationThe device has no vibration function magnetic fieldsThe device will pass the EMC testing according to EN IEC 60601 1 2 6 2 2 Biological hazards and contributory factors Biological hazardsEvaluation bio contaminationThe cuff contact to patient bio incompatibilityThe cuff contact to patient incorrect formulation chemical composition The device has no chemical composition production during the manufacturing toxicityAll the component of device has pass the RoHS test allergenicity mutagenicity The cuff contact to patient Attachment 6 AGE Automatic Wrist Blood Pressure Monitor Risk Management Report Page 9 of 15 oncogenicity teratogenicity carcinogenicity re and or cross infection The cuff contact to patient It will not bring the cross infection between patient However maybe bring the user s cross infection But the severity and likelihood is very low The risk is acceptable pyrogenicity The device uses 2 AAA batteries Device will not bring fire or heat inability to maintain hygienic safety The cuff contact to patient It will not bring the cross infection between patient However maybe bring the user s cross infection But the severity and likelihood is very low The risk is acceptable degradationThe device cannot bring degradation 6 2 3 Environmental hazards and contributory factors Environmental hazardsEvaluation electromagnetic fieldsThe device uses 2 AAA batteries it need to pass the EMC test susceptibility to electromagnetic interference The device uses 2 AAA batteries it need to pass the EMC test emissions of electromagnetic interference The device uses 2 AAA batteries it need to pass the EMC test inadequate supply of powerThe device will phonate Beep noise when the power is not inadequate It will be described in the user manual as a caution inadequate supply of coolantThe device needn t coolant supply storage or operation outside prescribed environmental conditions The operation environment will affect the device measurement result Normal conditions of use 1 Operating temperature 5 C to 40 C 2 Humidity rate 85 The user manual has described it as a caution incompatibility with other devices with which it is intended to be used This device is use separated accidental mechanical damageThe device has no mechanical damage to human body contamination due to waste products and or medical device disposal The device contain 2 AAA batteries company has put a WEEE mark on the package to guide customer how to handle the waster degradationThe device has no degradation hazard 6 2 4 Hazards resulting from incorrect output of energy and substances HazardsEvaluation Attachment 6 AGE Automatic Wrist Blood Pressure Monitor Risk Management Report Page 10 of 15 electricityThe device uses 2 AAA batteries Device will not conduct shock or electricity hazard radiationThe device has no radiation The device will not bring radiation hazard volumeThe device has no volume The device will not bring radiation hazard pressureThe device will give pressure to patient Over pressure may hurt patient supply of medical gases The device has no supply of medical gas supply of anaesthetic agentsThe device has no supply of anaesthetic agents 6 2 5 Hazards related to the use of the medical device and contributory factors HazardsEvaluation inadequate labellingThe labeling is complying with EN980 EN IEC 60601 1 inadequate operating instructions such as inadequate specification of accessories to be used with the medical device inadequate specification of pre use checks over complicated operating instructions inadequate specification of service and maintenance It would be better to remind the user to check the device before the 1st use use by unskilled untrained personnel There are cautions put on the user manual reasonably foreseeable misuseThe Warning is sufficient insufficient warning of side effects The Warning is sufficient inadequate warning of hazards likely with re use of single use medical devices The device can be re using incorrect measurement and other metrological aspects The metrological aspects are according to national standard incompatibility with consumables accessories other medical devices The device needn t access to other device sharp edges or pointsThe shell is smooth and no sharp edges 6 2 6 Inappropriate inadequate or over complicated user interface man machine communication Attachment 6 AGE Automatic Wrist Blood Pressure Monitor Risk Management Report Page 11 of 15 HazardsEvaluation mistakes and judgement errorsIt woks automatically slips and blunders mental or physical The device will pass the fall off test before out factory violation or abbreviation of instructions procedures etc It woks automatically complex or confusing control system The system is simple ambiguous or unclear device state The user manual is clearly described ambiguous or unclear presentation of settings measurements or other information The indication for use is clearly described misrepresentation of resultsThe use manual notified that the accuracy of this device insufficient visibility audibility or tactility The display is clear and the noise is audibility poor mapping of controls to action or of displayed information to actual state The device is controlled by software Easy control controversial modes or mappings as compared to existing equipment There are no controversial modes or mappings as compared to existing equipment 6 2 7 Hazards arising from functional failure maintenance and ageing and contributory factors HazardsEvaluation erroneous data transfer The device needn t transfer the measurement date lack of or inadequate specification for maintenance including inadequate specification of post maintenance functional checks The user manual has described clearly how to use it and how to maintain it The device has a self testing function while turn on before use inadequate maintenanceThe user manual has described clearly how to use it and how to maintain it The device has a self testing function while turn on before use lack of adequate determination of the end of life of the medical device Attachment 6 AGE Automatic Wrist Blood Pressure Monitor Risk Management Report Page 12 of 15 loss of electrical mechanical integrity The 2 AAA batteries are fixed in the device by a shell with screw on it It is difficult to loss of power inadequate packaging The device packaging is suitable and stable for the device It is adequate re use and or improper re useThe device could be re use deterioration in function e g gradual occlusion of fluid gas path or change in resistance to flow electrical conductivity as a result of repeated use It shall comply the SP10 requirements Attachment 6 AGE Automatic Wrist Blood Pressure Monitor Risk Management Report Page 13 of 15 7 Risk Evaluation and control Result of actionFunction Process Failure modeHarmOSFailure reasonsCurrent control R P N ConclusionsAction planRectified measures S ORPN Switch Switch Loss function Cannot use the device 41Switch Loss function 1 IQC on switch 2 Fall down test in FQC 4ACC PCB PCB loss function Cannot use the device or Accuracy cannot achieve 32 1 NC component 2 PCBA NC in Soldering process 3 NC PCB pass the IPQC 1 IQC for component 2 PCBA IPQC 3 Process Validation 6ACC 2 AAA batteries Loss power Cannot use the device 41 Long time no use or over use of batteries The device software has a self testing function after turn before use Low power display warning 4ACC 2 AAA batteries Leak Contaminated32Long time no use When the LCD screen displays Battery the battery is used Operation Open the lid and change the batteries 4ACC DisplayLoss function Cannot use the device 31 NC display come into device IQC for display FQC Function test 100 3ACC PCBA