M55042-1.0, Risk Management Summary, Medikro Spirometer System
Contents
1. M55042 1 0 RISK MANAGEMENT SUMMARY REPORT SpiroStar USB and SpiroStar DX Made by KV 7 3 2008 Kimmo Vauhkonen Checked by OP 7 3 2008 Olli Pohjolainen Accepted by OP 7 3 2008 Olli Pohjolainen 1 Scope This Risk Management Summary Report specifies the systematic approach to evaluation of hazards associated with the Medikro SpiroStar USB and DX spirometers by identifying the intended use device characteristics and hazards and estimating the risks associated with the device Information from SpiroStar USB SpiroStar DX Disposable Flow Transducer and Spiro2000 Software Risk Management Files was used to complete this Risk Management Summary Report 2 Methodology RISK LEVEL for each hazard is estimated Design and testing solutions are then taken into account which reduce the hazard The new RESIDUAL RISK LEVEL is then evaluated and if necessary re evaluated later based on the actual RESIDUAL RISK Risk Management is made according to Medikro s internal procedure M7421 Risk Management Procedure and in accordance with ISO 13485 2003 Risk Management Standard 2 1 Propability levels 1 Almost Impossible Zero propability of occurance 2 Remote Unlike to occur but possible 3 Occasional likely to occur in sometime in the lifetime of the device 4 Probable likely to occur several times in the lifetime of the device 5 Frequent likely to occur often 2 2 Severity levels 1 Insignificant not a safety risk 2 Minimum cau2. is used wrongly No volume calibration Wrong Linearization File wo N a A comprehensive Operator Help System User Manual and Quick Reference Cards are supplied with each system Equipment is used in hospitals and physicians offices where specialists or professionals are familiar with common Spirometry principles and similar medical equipment Flow Transducers are lot coded and the use is instructed User Instructions Labelling N Y 5 5 Over complicated operating instructions Device is used wrongly A comprehensive Operator Help System User Manual and Quick Reference Cards are supplied with each system Equipment is used in hospitals and physicians offices where specialists or professionals are familiar with common Spirometry principles and similar medical equipment User Instructions 5 6 Unavailable or separated operating instructions Device is used wrongly A comprehensive Operator Help System User Manual and Quick Reference Cards are supplied with each system Equipment is used in hospitals and physicians offices where specialists or professionals are familiar with common Spirometry principles and similar medical equipment User Instructions 5 7 Use by unskilled untrained personnel Device is used wrongly A comprehensive Operator Help System User Manual and Quick Reference Cards are supplied with each system Equipment is used in hospitals and physicians offices
3. not produce substances or energy 2 5 Incorrect formulation chemical composition N A use of tested materials 2 6 Toxicity Skin or mucosa irritation allergy is 2 2 4 Use of tested materials Material certificates 1 1 1 minimized by biocompatibility Biocompatibility Test Results evaluation 2 7 Allergenicity Skin or mucosa irritation allergy is 2 3 6 Use of tested materials Material certificates 1 2 2 minimized by biocompatibility Biocompatibility Test Results evaluation 2 7 Cross Infection Infection risk is minimized with the 3 3 9 Medikro Spirometer uses a Flow Transducer Safety 2 2 4 use of Disposable Single Use Flow single use Flow Sensor and is _ Instructions and product labels Transducer labeled as such 2 8 Pyrogenicity N A 2 9 Inability to maintain hygienic safety Infection risk is minimized with the 2 2 4 Medikro Spirometer uses a Flow Transducer Safety 1 2 2 use of Disposable Single Use Flow single use Flow Sensor and is _ Instructions and product labels Transducer labeled as such 2 10 Degradation Risk is minimized by recommended 3 1 3 Daily calibration User Manual 2 1 2 daily calibration with Calibration Quick Instructions INITIAL RESIDUAL RISK LEVEL RISK LEVEL Z a gt S z 3 E 3 E a amp N a Gi o o gt x lt o gt x lt RISK TYPE POTENTIAL HARM o o PREVENTIVE PREVENTIVE ACTION alol o ACTIONS DOCUMENTS AND RECORDS 3 EN
4. where specialists or professionals are familiar with common Spirometry principles and similar medical equipment User Instructions 5 8 Reasonably foreseeable misuse Device is used wrongly System does not pose any harm Professionals or specialists review results User Instructions 5 9 Insufficient warning of side effects N A System does not provide or administer any energy to patients use of single use devices 5 10 Inadequate warning of hazards likely with re Disposable Flow Transducer is re used Flow Transducers are labelled as Disposable and attached documentation includes all necessary warnings Equipment is used in hospitals and physicians offices where specialists or professionals are familiar with common Spirometry principles and similar medical equipment User Instructions Labelling INITIAL RESIDUAL RISK LEVEL RISK LEVEL gt gt m a gt S z 3 E 3 E a amp n a Gi N ol gt 2 Q Zl x RISK TYPE POTENTIAL HARM D a PREVENTIVE PREVENTIVE ACTION a O a ACTIONS DOCUMENTS AND RECORDS 5 11 Incorrect measurement and other Erroneous results 3 2 6 A comprehensive Operator Help User Instructions 2 2 4 metrological aspects System User Manual and Quick Reference Cards are supplied with each system Equipment is used in hospitals and physicians offices where specialists or professionals are familiar with commo
5. 2 6 A comprehensive Operator Help User Instructions 2 2 4 System User Manual and Quick Labelling Reference Cards are supplied with each system Equipment is used in hospitals and physicians offices where specialists or professionals are familiar with common Spirometry principles and similar medical equipment Flow Transducers are lot coded and the use is instructed 5 2 Inadequate operating instructions Device is used wrongly 3 2 6 A comprehensive Operator Help User Instructions 2 2 4 System User Manual and Quick Reference Cards are supplied with each system Equipment is used in hospitals and physicians offices where specialists or professionals are familiar with common Spirometry principles and similar medical equipment 5 3 Inadequate specification of accessories Device is used wrongly 3 2 6 A comprehensive Operator Help User Instructions 2 2 4 System User Manual and Quick Labelling Reference Cards are supplied with each system Equipment is used in hospitals and physicians offices where specialists or professionals are familiar with common Spirometry principles and similar medical equipment Flow Transducers are lot coded RISK TYPE POTENTIAL HARM INITIAL RISK LEVEL PROBABILITY SEVERITY PXS PREVENTIVE ACTIONS PREVENTIVE ACTION DOCUMENTS AND RECORDS RESIDUAL RISK LEVEL PROBABILITY SEVERITY PXS 5 4 Inadequate specification of pre use checks Device
6. Medikro 26 Will new manufacturing processes need to be established or introduced Manufacturing and QA instructions to each component 27 Is successful application of the device critically dependent on human factors such as the user interface Software user interface is essential part of the use of the device 28 Is the device intended to be mobile or portable The device is stand alone but can be used with a laptop PC 29 Essential performance identification Device shall meet ATS and ERS spirometry recommendations 30 Critical components Biocompatibility Disposable Flow Transducer Measurement accuracy Pressure sensor Disposable Flow Transducer Electrical Safety Not critical factor because patient is isolated even from the device unit and USB Serial port via 2m plastic pressure tube Though device shall meet IEC EN 60601 leakage current requirements and other requirements 4 Risk Management Process ISO13485 2003 Steps 2 11 INITIAL RESIDUAL RISK LEVEL RISK LEVEL gt gt E gt gt 2 E 2 El o El o 2 g gl g RISK TYPE POTENTIAL HARM a o a PREVENTIVE PREVENTIVE ACTION a o a ACTIONS DOCUMENTS AND RECORDS 1 ENERGY HAZARDS 1 1 Electricity Minor electrical shock temperary 2 2 4 Safety testing Patient safety test Reports 2 1 2 pain according to Not likely even in fault conditi
7. VIRONMENTAL HAZARDS 3 1 Electromagnetic interference Device malfunction or interference is 3 3 9 EN IEC 60601 1 2 EMC EN IEC 60601 1 2 EMC Test 2 2 4 minimized by EMC testing compatibilty Report 3 2 Inadequate supply of power or coolant N A If the device do not get power it does not work No need for cooling 3 3 Restriction of cooling N A No need for cooling 3 4 Likelihood of operation outside prescribed Device malfunction may be present 2 2 4 Safety Test Report EN60601 1 2 2 4 environmental conditions only in extreme environmental conditions Even in those conditions there is not foreaseeable risks for patient health 3 5 Incompatibility with other devices Does not work with older PC 3 1 3 Technical Specifications Technical Specifications 2 1 2 3 6 Accidental mechanical damage Device malfunction the false 2 1 1 Mechanical structure stable Safety Test Report EN60601 1 2 1 1 operation is very likely obvious device simply stops working 3 7 Accidental electronic damage Device malfunction the false 2 1 1 Safety Test Report EN60601 1 2 1 1 operation is very likely obvious 3 8 Contamination due to waste products N A and or device disposal 4 HAZARDS RESULTING FROM INCORRECT OUTPUT OF ENERGY AND SUBSTANCES 4 1 Electricity N A Device does not output energy 4 2 Radiation 4 3 Volume 4 4 Pressure 4 5 Supply of medical gases 4 6 Supply of anaesthetic agents 5 HAZARDS RELATED TO USE OF THE DEVICE 5 1 Inadequate labelling Device is used wrongly 3
8. ctions in hospitals and physician procedures etc offices Equipment is used in 6 5 Complex or confusing control system hospitals and physicians offices 6 6 Ambiguous or unclear device state where specialists or 6 7 Ambiguous or unclear presentation of professionals are familiar with settings measurements or other information common Spirometry principles 6 8 Misrepresentation of results and similar medical equipment 6 9 Insufficient visibility audibility or tactility 6 10 Poor mapping of control to action or of displayed information to actual state 6 11 Controversial modes or mappings as compared to existing equipment 7 HAZARDS ARISING FROM FUNCTIONAL FAILURE MAINTENANCE AND AGEING 7 1 Inadequacy of performance characteristics Erroneous treatment of patients 2 2 4 Spirometry systems are one of User Instructions 2 2 4 for the intended use several different types of Spirometry diagnostic tools used in hospitals and physician offices Equipment is used in hospitals and physicians offices where specialists or professionals are familiar with common Spirometry principles and similar medical equipment 7 2 Lack of or inadequate specification for Daily volume calibration is ERS ATS 2 2 4 Daily volume calibration Technical Manual and User 2 2 4 maintenance including inadequate specification recommendation ERS amp ATS recommendations Instructions of post maintenance functional checks If this is not done the risk for Spirometry systems are one o
9. f measurement accuracy problems several different types of slightly increases but is still very Spirometry diagnostic tools used small in hospitals and physician offices Equipment is used in hospitals and physicians offices where specialists or professionals are familiar with common Spirometry principles and similar medical equipment INITIAL RESIDUAL RISK LEVEL RISK LEVEL Z Z a gt S z 3 E 3 E a amp n a Gi N o gt x lt o gt x lt RISK TYPE POTENTIAL HARM a D a PREVENTIVE PREVENTIVE ACTION a O a ACTIONS DOCUMENTS AND RECORDS 7 3 Inadequate maintenance Daily volume calibration is ERS ATS 2 2 4 Daily volume calibration Technical Manual and User 2 2 4 recommendation ERS amp ATS recommendations Instructions If this is not done the risk for Spirometry systems are one of measurement accuracy problems several different types of slightly increases but is still very Spirometry diagnostic tools used small in hospitals and physician offices Equipment is used in hospitals and physicians offices where specialists or professionals are familiar with common Spirometry principles and similar medical equipment ERS amp ATS recommendations 7 4 Lack of adequate determination of end of Device life is estimated to be 5 years 2 2 4 The life cycle of the device is as Technical Manual and User 2 2 4 device life long as the daily volume Instructions calib
10. ho installs the device Local IT support personell or end user according to installation instructions provided by Medikro 1 6 Can the patient influence the use of the device Patient subject can not use the device by himself herself 1 7 Users with special needs like handicapped The product is designated for use on both adult and pediatric patients Normal values and comparative results are not calculated for children under the age of six 2 Is the device intended to contact the patient or other persons 2 1 Patient The disposable flow transducer is a single use component intended to have direct contact with the patient s mucosal membranes within the mouth Duration less than 30 minutes typically a few minutes Nose Clip has contact with patients skin nose Duration less than 30 minutes typically a few minutes 2 2 Other persons Randon skin contacts with outer surfaces of disposable flow transducer tubing nose clip or device 3 What materials and or components are incorporated in the device or are used 3 1 Are the characteristics relevant to safety known Biocompatibility characteristics of the disposble flow transducer are identified ISO 10993 testing etc Material properties of random patient contact materials are identified food contact approval statements data sheets etc 4 Is energy delivered to and or extracted from the patient No 5 Are substances delivered to and or extracted from the patie
11. n Spirometry principles and similar medical equipment Professionals or specialists review results 5 12 Incorrect diagnosis Errorneus diagnosis 2 3 6 User Manual and diagnosis by User Instructions 1 3 3 MD System does not provide direct diagnostic to user 5 13 Erroneous data transfer Data lost 3 3 6 Operator Help System advises User Instructions 2 2 4 the medical technician to re load the information 5 14 Mispresentation of results System does not provide direct 2 2 4 User Manual and diagnosis by User Instructions 2 2 4 diagnostic statements Physician MD professional or specialist review required 5 15 Incompatibility with consumables laccessories other devices PC hardware HW compatibility processor speed RAM size serial or USB port Not functioning in all PCs Not a 3 1 3 Minimum HW specifications and Minimum specfications in 2 1 2 display resolution safety issue product testing brochures and User Instructions Operating system OS compatibility Not functioning in DOS and older 3 f 3 OS specifications and product Minimum specfications in 2 1 2 Windows Not a safety issue testing brochures and User Instructions 6 INAPPROPRIATE INADEQUATE OR OVER COMPLICATED USER INTERFACE 6 1 Mistakes and judgement errors 2 2 Spirometry systems are one of 2 2 4 6 2 Lapses and cognitive recall errors several different types of 6 3 Slips and blunders mental or physical Spirometry diagnostic tools used 6 4 Violation or abbreviation of instru
12. nt No 6 Are biological materials processed by the device for subsequent re use No 7 Is the device supplied sterile or intended to be sterilized by the user or are other microbiological controls applicable No Disposable flow transducer is a single use instrument 8 Is the medical device intended to be routinely cleaned and disinfected by the user No Disposable flow transducer is a single use instrument 9 Is the device intended to modify the patient environment No 10 Are measurements made Yes The list of measured and or calculated variables is specified in User Manual and Design Documents 11 Is the device interpretative The spirometer gives a short interpretation from results MD gives final diagnosis 12 Is the device intended to control or to interact with other devices or drugs Yes Spirometer is connected to PC via serial or USB port and needs application software Spiro2000 13 Are there unwanted outputs of energy or substances No 14 Is the device susceptible to environmental influences The environmental parameter ranges are Operating temperature 10 40 C Storage temperature 10 40 C Relative atmospheric humidity 5 85 Barometric pressure 600 1060 hPa 15 Does the medical device influence the environment No 16 Essential disposable materials Plastic Disposable Flow Transducer and Nose Clip Spirometer Unit includes elec
13. ons IEC EN 60601 1 1 2 Heat N A no heat risks 1 3 Mechanical force Leaks or compression of plastic 3 2 6 User instructions User instructions 2 2 4 tubing between disposable flow Installation instructions transducer and device may cause erroneus pressure signal and erroneous air flow signal 1 4 lonizing radiation N A no radiation risks 1 5 Non ionizing radiation N A no radiation risks 1 6 Electromagnetic fields N A no EMF production 1 7 Moving parts N A no moving parts 1 8 Suspended masses N A no suspended masses 1 9 Patient support device failure N A not a patient support device 1 10 Pressure vessel rupture N A 1 11 Acoustic pressure N A no effects on acustic pressure 1 12 Vibration N A no effects on vibration Does not produce vibration 1 13 Magnetic fields e g MRI N A not intended for use in external magnetic fields Does not produce magnetic fields 2 BIOLOGICAL HAZARDS 2 1 Bio burden N A Parts not sterilized nor intended for sterilization 2 2 Bio contamination Infection risk is minimized with the 3 3 9 Medikro Spirometer uses a Flow Transducer Safety 2 2 4 use of Disposable Single Use Flow single use Flow Sensor andis Instructions and product labels Transducer labeled as such 2 3 Bio incompatibility Skin or mucosa irritation allergy is 3 3 9 Use of tested materials Material certificates 2 1 2 minimized by biocompatibility Biocompatibility Test Results evaluation 2 4 Incorrect output substance energy N A device does
14. ration can be successfully completed and the verification gives the accuracy of 3 of the volume 7 5 Loss of mechanical integrity No foreaseeable danger to the 2 1 2 Device meet safety standards Safety Test Report EN60601 1 2 1 2 operator or patient 7 6 Inadequate packaging contamination and or The device will be shipped in 2 2 4 Proper packing Packing instructions and 2 2 4 deterioration of the device adequate packaging to ensure arrival specifications at the user destination in good condition 7 7 Improper re use The Medikro Flow Transducer is a 2 3 6 Instructions are provided User Instructions 1 2 3 single use device additionally tha equipment is used in hospitals and physicians offices where specialists or professionals are familiar with common hygiene and spirometry principles and similar medical equipment 8 OTHER SOFTWARE RISKS 8 1 SW installation not properly completed Application software does not 3 1 3 Instructions Installation instructions 2 1 2 function No safety risks 8 2 SW failures bugs Device doesn t operate as specified 4 2 8 Software verification and Software validation verification 3 2 6 the program collaps etc validation testing and test reports 8 3 Database use Wrong data entry to database 3 2 6 Software verification and Software validation verification 2 2 4 Use of wrong ID number from validation testing and test reports database Exit from application software before database update is completed Da
15. ses annoyance to the user not likely to cause any actual injury 3 Minor may cause inconvenience temperary injury possible 4 Medium safety risk injury possible death unlikely 5 Major significant safety hazard death or serious injury possible 2 3 Risk level index 1 9 No preventive actions required 10 15 Preventive action required Residual risk acceptance shall be made if the risk index stays in this level gt 15 Untolerable risk 3 Intended use purpose and identify characteristics Step 1 from ISO 14971 2000 Annex A 1 What is the intended use and how is the device to be used 1 1 Intended use Diagnostic spirometer A device that measures lung air volume and airflow rate for pulmonary disease diagnosis and screening These measurements provide information about a patient s pulmonary function which may be compared with normal values or the patient s former values The Medikro Spirometer is intended for use by or on the order of a physician in a hospital or clinical setting 1 2 Intended user Healthcare professionals with appropriate education including medical doctors nurses and occupational nurses 1 3 Required skill and training of the user Skills Basic medical competence for making spirometry studies Training User Manual 1 4 Operational environment Operating temperature 10 40 C Storage temperature 10 40 C Relative atmospheric humidity 5 85 Barometric pressure 600 1060 hPa 1 5 W
16. tabase corruption 8 4 Operator faults Wrong deletion of patient data 3 2 4 Modifications need operator User Instructions 2 2 4 Wrong deletion of signal data confirmation Patient study using wrong ID data Wrong linearization file User manual instructions Wrong environmental settings User Responsibility 5 Conclusion The operation of the Medikro Spirometer its design and development its operating software specifications coding testing and operator manual have been carefully analyzed to identify the hazards associated with their use Medikro s overall document control and Engineering Development procedures have also been reviewed In all situations it has been concluded that appropriate measures have been taken to address all identified potential hazards associated with each of these components of the Medikro Spirometer System and it s use Version history Version Date Changes what why 1 0 7 3 2008 Information from SpiroStar USB SpiroStar DX Disposable Flow Transducer and Spiro2000 Software Risk Management Files was used to complete this Risk Management Summary Report
17. tronics 17 Is maintenance and or calibration necessary Daily system calibration is recommended 18 Does the device contain software Yes installed by the IT personell end user or the supplier 19 The time limit for storage Two 2 years for the disposable flow transducer 20 Possible delayed and or long term use effects Product is never used for extended time periods 21 To what mechanical forces will the device be subjected Disposable flow transducer connector with plastic tubing is linked plastic tubing may be erroneously pressed instrument is connected to PC serial USB port 22 What determines the lifetime of the device The life cycle of the device is as long as the daily system calibration can be successfully completed and the verification gives the accuracy of 3 of the volume 23 Is the device intended for single use or re use Disposable flow transducer is single use The device excluding disposable flow transducer is intended as re usable device 24 Is safe decommissioning or disposal of the device necessary Single used parts shall be disposed according to local regulations usually with normal hospital waste Device shall be disposed according to local regulations in EU according to WEEE directive 25 Does installation or use of the device require special training Medical professionals should be able to use the device according to instructions provided by
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