ResMed product servicing requirements
Contents
1. Fax 61 8884 2000 ABN 30 003 765 142 Global leaders in sleep and sata medicine www resmed com 110198 5 RESMED TECHNIC A De Sse hyv Ce gt H PA Training plan ResMed product servicing requirements May 2013 Service personnel must be familiar with ResMed s definition of a complaint and know the appropriate complaint handling procedures service technician has suitable electrical and mechanical training to satisfy the requirements of the relevant regulatory authorities Training requirements The service technician must have completed training for any product platform they are servicing or reworking Personnel must demonstrate completion of training to ResMed s complaint handling and adverse event escalation procedures to ensure that ResMed is able to comply to its regulatory requirements for complaints handling Records of training undertaken by service centre personnel must be maintained Revision of training should be undertaken at a minimum of every 3 years and training records updated accordingly OOU OL Where hand soldering is conducted training to IPC standards is required Competency criteria Upon the completion of service training the following competencies are expected Familiar with ESD and environment control standards E Understand the complaint and repair reporting requirements Familiar with cleaning and handling controls Familiar with the product E E 7 Familiar with the different2. handling and repairs are done must have surfaces of suitable conducting material connected via a 1 MUiresistor to an electrical ground The area under and also in front of the work bench must be coated with a suitable conductive floor paint or alternatively covered with a conductive floor mat The conductive paint coating or floor mat must be connected to an electrical ground Soldering irons and equipment soldering irons or solder baths must be at the same reference ground potential as the work bench Personnel A wrist strap must be worn by service personnel working at the bench The wrist strap must have a conductive lead 1 M connected to the bench surface Alternatively a heel ground Strap to ground the operator to the floor may be used Such a wrist or heel strap should not create an electrical hazard for the wearer ResMed Ltd 1 Elizabeth Macarthur Drive Bella Vista NSW 2153 Australia Tel 61 2 8884 1000 Fax 61 8884 2000 ABN 30 003 765 142 Global leaders in sleep and respiratory medicine www resmed com eae 110198 5 RESMED TECHNIC A De Sse hyv Ce gt H PA Training plan ResMed product servicing requirements May 2013 Service facilities PC requirements Minimum requirement for Service software e PC running Windows XP Vista 32 bit or 7 32 bit Access to Tech Support Website Note This will be provided at the discretion of the regional Technical S
3. product servicing requirements May 2013 Inventory spare parts Sufficient controls must be in place to ensure that there is no risk of using faulty spare parts and obsolete spare parts Parts with shelf life such as batteries must be identified and appropriately stored to avoid deterioration of shelf like during storage Spare parts must Be ResMed approved parts Are not parts that have failed show excessive wear have been contaminated or are ineffective for their intended use Recording repair details and complaints handling ResMed requires that all distributors maintain complete and accurate records of all customer s repaired goods and all other records as required by law for a minimum of five 5 years from the date of sale to the customer Distributors must display an established process for capturing and maintaining repair records The minimum requirement for each repair record is e Unique repair identification e Parts used in repair e Serial number e Warranty status e Product code e Customer details e Brief description of problem e Date of service e Brief description of cause e Name of individual servicing unit e Repair action taken e Test and calibration results The database for capturing records Oracle OR Repairs Report Database OR Other Please provide details below Complaints handling ResMed Ltd 1 Elizabeth Macarthur Drive Bella Vista NSW 2153 Australia Tel 61 2 8884 1000
4. products in the series where applicable Recognise the major sub assemblies in the product Be able to properly perform the assembly disassembly procedures for the product Be able to correctly test and calibrate the product Recognise and be familiar with the common failure modes in the product Be familiar with the technical services website ind icates requirements for service technicians only ResMed Ltd 1 Elizabeth Macarthur Drive Bella Vista NSW 2153 Australia Tel 61 2 8884 1000 Fax 61 8884 2000 ABN 30 003 765 142 Global leaders in sleep and respiratory medicine www resmed com Page 5 110198 5
5. RESMED TECHNIC A De Sse hyv Ce gt H Ini Training plan ResMed product servicing requirements May 2013 Scope These requirements apply to all service centres which service and rework ResMed products including ResMed service centres external distributors and sub contractors Work environment Contamination controls It is ResMed policy to promote a clean and tidy work environment It is imperative to keep service areas clean dry and free from accumulate waste dirt and debris The following is required of the service environment An area should be designated for the cleaning of returned units This area should be wiped down with a lint free cloth and a cleaning agent with a high alcohol content e g isopropyl alcohol once a day or as required Warning When using a cleaning agent with a high alcohol content refer to the appropriate Material Safety Data Sheet MSDS to ensure safe handling of the cleaning agent agent with a high alcohol content as required The floor is to be kept clear of rubbish and other items at all times service technicians are to ensure that they maintain a high level of personal hygiene Use of Work stations are to be kept as clean and clear as possible and wiped down with a cleaning highly scented antiseptic cleaners should be avoided For personal protection and to ensure product quality jewellery and other items that could damage products must be removed or otherwise preve
6. ervices Manager Access to email with mailbox supporting attachments up to 7 MB Service equipment The range and accuracy of measuring equipment must meet the minimum requirements stated within the relevant service manual Equipment required Pressure manometer Flow meter Flow regulation valve Digital thermometer with external probe Other product specific equipment as stated in the relevant service manual Calibration control Measuring and testing devices used for servicing must be calibrated have a calibration certificate and calibration records maintained Inventory units for servicing Sufficient controls must be in place to ensure that there is no risk of mix up of faulty products products undergoing repair or products that have completed the servicing requirement For example upon receipt of a unit for servicing the unit is to be labelled with the following information e Customer details e Product details e Problem details Labelling should be clearly visible and securely fastened to the item it is identifying Note A service request form can be used for this purpose and attached to the front of the unit ResMed Ltd 1 Elizabeth Macarthur Drive Bella Vista NSW 2153 Australia Tel 61 2 8884 1000 Fax 61 8884 2000 ABN 30 003 765 142 Global leaders in sleep and respiratory medicine www resmed com Page 3 110198 5 RESMED TECHNICA Ls SERV ECE Ss H PA Training plan ResMed
7. nted from coming into contact with products Units returned for service or repair Before the servicing or repair activity commences all units returned for repair are to be cleaned This will ensure units are clean thus reducing the risk of contamination and cross infection Upon receipt of a unit it should be taken to the designated cleaning area The unit should be wiped down with a lint free cloth and a cleaning agent with a high alcohol content e g isopropyl alcohol The device should then be clearly identified as having been cleaned ResMed Ltd 1 Elizabeth Macarthur Drive Bella Vista NSW 2153 Australia Tel 61 2 8884 1000 Fax 61 8884 2000 ABN 30 003 765 142 Global leaders in sleep and respiratory medicine www resmed com Page 1 110198 5 RESMED TECHNIC A De Sse hyv Ce gt H PA Training plan ResMed product servicing requirements May 2013 Environmental controls Environmental controls are required to ensure product quality and testing accuracy when servicing and storing ResMed products and parts Temperature and humidity limits for ResMed devices are shown in the table below Parameter Recommended value Temperature 10 35 C Humidity 15 95 RH Note These limits must be adjusted by the service centre to comply with any test or measuring equipment used that is not already specified to operate to or beyond these limits Static precautions Work station Work benches where
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