Documentation & Training FCI 7814 Replace of shutter valid for Dornier Medilas H Solvo and Dornier Medilas H UroPulse Product : Subject Datum Priority Qual. support Telephone Telefax Email : : : : : : : Dornier Medilas H Solvo and Dornier Medilas H UroPulse Shutter failures 19 November 2013 Next visit Raimund Bischoff +49 8153 888 209 +49 8153 888 210 rbischoff@dornier.com Weitergabe sowie Vervielfältigung dieser Unterlagen, Verwertung und Mitteilung ihres Inhalts ist nicht gestattet, soweit nicht ausdrücklich zugestanden. Zuwiderhandlungen verpflichten zu Schadensersatz. Alle Rechte für den Fall der Patenterteilung oder Gebrauchsmuster-Eintragung vorbehalten. Copying of this document, its divulgation, and the use of communication of the contents thereof are forbidden without express authorization. Offenders are liable to the payment of damages. All rights are reserved in the event of the grant of a patent or the registration of a utility model or design. FCI 7814 Table of Contents 1 Reason for Modification ........................................................................... 2 2 Extent of Modification .............................................................................. 2 3 Logistics .................................................................................................... 7 4 Perform Modification ................................................................................ 8 5 Perform Final Test .................................................................................... 9 6 Quality Control .......................................................................................... 9 7 Documentation.......................................................................................... 9 Appendix: FCI-Feedback Form Page 1 of 10 FCI 7814 1 Reason for Modification Reduce the potential for an ERROR 16 (shutter failure). 2 Extent of Modification Systems affected: see tables below DMT America Dornier Medilas H Solvo Serial No. MEDILAS H SOLVO MEDILAS H SOLVO MEDILAS H SOLVO MEDILAS H SOLVO MEDILAS H SOLVO MEDILAS H SOLVO MEDILAS H SOLVO MEDILAS H SOLVO WL MEDILAS H SOLVO WL MEDILAS H SOLVO WL MEDILAS H SOLVO WL MEDILAS H SOLVO WL MEDILAS H SOLVO WL MEDILAS H SOLVO WL MEDILAS H SOLVO WL MEDILAS H SOLVO WL MEDILAS H SOLVO WL MEDILAS H SOLVO WL MEDILAS H SOLVO WL MEDILAS H SOLVO WL MEDILAS H SOLVO WL MEDILAS H SOLVO WL MEDILAS H SOLVO WL MEDILAS H SOLVO WL MEDILAS H SOLVO WL MEDILAS H SOLVO WL MEDILAS H SOLVO WL MEDILAS H SOLVO WL MEDILAS H SOLVO WL MEDILAS H SOLVO WL MEDILAS H SOLVO WL MEDILAS H SOLVO WL MEDILAS H SOLVO WL MEDILAS H SOLVO WL MEDILAS H SOLVO WL H30-0014 H30-0015 H30-0016 H30-0017 H30-0019 H30-0020 H30-0021 H30-0025 H30-0026 H30-0027 H30-0028 H30-0029 H30-0030 H30-0031 H30-0032 H30-0034 H30-0035 H30-0037 H30-0039 H30-0040 H30-0041 H30-0042 H30-0043 H30-0045 H30-0046 H30-0047 H30-0048 H30-0049 H30-0051 H30-0054 H30-0055 H30-0059 H30-0060 H30-0062 H30-0064 Comment Page 2 of 10 FCI 7814 MEDILAS H SOLVO WL MEDILAS H SOLVO WL MEDILAS H SOLVO WL MEDILAS H SOLVO WL MEDILAS H SOLVO WL MEDILAS H SOLVO WL MEDILAS H SOLVO WL MEDILAS H SOLVO WL MEDILAS H SOLVO WL MEDILAS H SOLVO WL MEDILAS H SOLVO WL MEDILAS H SOLVO WL MEDILAS H SOLVO WL MEDILAS H SOLVO WL MEDILAS H SOLVO WL MEDILAS H SOLVO WL MEDILAS H SOLVO WL MEDILAS H SOLVO WL MEDILAS H SOLVO WL MEDILAS H SOLVO WL MEDILAS H SOLVO WL MEDILAS H SOLVO WL MEDILAS H SOLVO WL MEDILAS H SOLVO WL MEDILAS H SOLVO WL MEDILAS H SOLVO WL MEDILAS H SOLVO WL MEDILAS H SOLVO WL MEDILAS H SOLVO WL MEDILAS H SOLVO WL MEDILAS H SOLVO WL MEDILAS H SOLVO WL MEDILAS H SOLVO WL MEDILAS H SOLVO WL MEDILAS H SOLVO WL MEDILAS H SOLVO WL MEDILAS H SOLVO WL MEDILAS H SOLVO WL MEDILAS H SOLVO WL MEDILAS H SOLVO WL MEDILAS H SOLVO WL MEDILAS H SOLVO WL MEDILAS H SOLVO WL MEDILAS H SOLVO WL MEDILAS H SOLVO WL Page 3 of 10 H30-0065 H30-0066 H30-0067 H30-0068 H30-0069 H30-0070 H30-0072 H30-0073 H30-0074 H30-0075 H30-0076 H30-0077 H30-0078 H30-0079 H30-0080 H30-0081 H30-0082 H30-0083 H30-0084 H30-0085 H30-0086 H30-0087 H30-0088 H30-0090 H30-0097 H30-0098 H30-0099 H30-0100 H30-0101 H30-0102 H30-0103 H30-0104 H30-0105 H30-0106 H30-0107 H30-0108 H30-0109 H30-0110 H30-0112 H30-0117 H30-0118 H30-0119 H30-0120 H30-0121 H30-0122 FCI 7814 MEDILAS H SOLVO WL MEDILAS H SOLVO WL MEDILAS H SOLVO WL MEDILAS H SOLVO WL MEDILAS H SOLVO WL MEDILAS H SOLVO WL MEDILAS H SOLVO WL MEDILAS H SOLVO WL MEDILAS H SOLVO WL MEDILAS H SOLVO WL MEDILAS H SOLVO WL MEDILAS H SOLVO WL MEDILAS H SOLVO WL MEDILAS H SOLVO WL MEDILAS H SOLVO WL MEDILAS H SOLVO WL MEDILAS H SOLVO WL MEDILAS H SOLVO WL MEDILAS H SOLVO WL MEDILAS H SOLVO WL MEDILAS H SOLVO WL MEDILAS H SOLVO WL MEDILAS H SOLVO WL MEDILAS H SOLVO WL MEDILAS H SOLVO WL MEDILAS H SOLVO WL MEDILAS H SOLVO WL MEDILAS H SOLVO WL MEDILAS H SOLVO WL MEDILAS H SOLVO WL MEDILAS H SOLVO WL MEDILAS H SOLVO WL MEDILAS H SOLVO WL MEDILAS H SOLVO WL MEDILAS H SOLVO WL MEDILAS H SOLVO WL MEDILAS H SOLVO WL MEDILAS H SOLVO WL MEDILAS H SOLVO WL MEDILAS H SOLVO WL H30-0125 H30-0131 H30-0132 H30-0134 H30-0135 H30-0136 H30-0139 H30-0140 H30-0141 H30-0142 H30-0143 H30-0147 H30-0148 H30-0149 H30-0152 H30-0153 H30-0154 H30-0155 H30-0156 H30-0157 H30-0158 H30-0159 H30-0160 H30-0161 H30-0165 H30-0166 H30-0167 H30-0168 H30-0169 H30-0170 H30-0171 H30-0172 H30-0173 H30-0174 H30-0177 H30-0178 H30-0179 H30-0180 H30-0182 H30-0183 Dornier Medilas H UroPulse MEDILAS H UROPULSE MEDILAS H UROPULSE MEDILAS H UROPULSE WL MEDILAS H UROPULSE WL Serial No. HRM-0011 HRM-0013 HRM-0017 HRM-0018 Shutter new Comment Page 4 of 10 FCI 7814 MEDILAS H UROPULSE WL MEDILAS H UROPULSE WL MEDILAS H UROPULSE WL MEDILAS H UROPULSE WL MEDILAS H UROPULSE WL MEDILAS H UROPULSE WL MEDILAS H UROPULSE WL MEDILAS H UROPULSE WL MEDILAS H UROPULSE WL MEDILAS H UROPULSE WL MEDILAS H UROPULSE WL MEDILAS H UROPULSE WL MEDILAS H UROPULSE WL HRM-0019 HRM-0022 HRM-0023 HRM-0033 HRM-0035 HRM-0040 HRM-0041 HRM-0042 HRM-0051 HRM-0052 HRM-0053 HRM-0054 HRM-0055 DMT Asia Dornier Medilas H Solvo MEDILAS H SOLVO MEDILAS H SOLVO WL MEDILAS H SOLVO WL MEDILAS H SOLVO WL MEDILAS H SOLVO WL MEDILAS H SOLVO WL MEDILAS H SOLVO WL MEDILAS H SOLVO WL MEDILAS H SOLVO WL MEDILAS H SOLVO WL MEDILAS H SOLVO WL Serial No. H30-0022 H30-0044 H30-0053 H30-0058 H30-0092 H30-0093 H30-0095 H30-0130 H30-0138 H30-0176 H30-0181 Comment Dornier Medilas H UroPulse MEDILAS H UROPULSE MEDILAS H UROPULSE WL MEDILAS H UROPULSE WL MEDILAS H UROPULSE WL MEDILAS H UROPULSE WL MEDILAS H UROPULSE MEDILAS H UROPULSE WL MEDILAS H UROPULSE WL MEDILAS H UROPULSE WL Serial No. HRM-0015 HRM-0020 HRM-0021 HRM-0024 HRM-0025 HRM-0029 HRM-0037 HRM-0039 HRM-0047 Comment Serial No. H30-0018 H30-0023 H30-0024 H30-0033 Comment DMT Europe Dornier Medilas H Solvo MEDILAS H SOLVO WL MEDILAS H SOLVO WL MEDILAS H SOLVO WL MEDILAS H SOLVO WL Page 5 of 10 FCI 7814 MEDILAS H SOLVO WL MEDILAS H SOLVO WL MEDILAS H SOLVO MEDILAS H SOLVO WL H30-0036 H30-0038 H30-0050 H30-0056 MEDILAS H SOLVO WL MEDILAS H SOLVO WL MEDILAS H SOLVO WL MEDILAS H SOLVO WL H30-0057 H30-0061 H30-0063 H30-0071 MEDILAS H SOLVO WL MEDILAS H SOLVO WL MEDILAS H SOLVO MEDILAS H SOLVO MEDILAS H SOLVO WL MEDILAS H SOLVO WL MEDILAS H SOLVO WL MEDILAS H SOLVO WL MEDILAS H SOLVO WL MEDILAS H SOLVO WL MEDILAS H SOLVO WL MEDILAS H SOLVO WL MEDILAS H SOLVO WL MEDILAS H SOLVO WL MEDILAS H SOLVO WL MEDILAS H SOLVO MEDILAS H SOLVO WL MEDILAS H SOLVO WL MEDILAS H SOLVO WL MEDILAS H SOLVO WL MEDILAS H SOLVO WL MEDILAS H SOLVO WL MEDILAS H SOLVO WL MEDILAS H SOLVO WL H30-0089 H30-0091 H30-0094 H30-0096 H30-0111 H30-0113 H30-0114 H30-0115 H30-0116 H30-0123 H30-0124 H30-0126 H30-0127 H30-0128 H30-0129 H30-0133 H30-0137 H30-0144 H30-0145 H30-0146 H30-0150 H30-0151 H30-0162 H30-0163 Dornier Medilas H UroPulse MEDILAS H UROPULSE WL MEDILAS H UROPULSE WL MEDILAS H UROPULSE WL MEDILAS H UROPULSE WL MEDILAS H UROPULSE MEDILAS H UROPULSE MEDILAS H UROPULSE WL MEDILAS H UROPULSE WL MEDILAS H UROPULSE WL MEDILAS H UROPULSE WL Serial No. HRM-0014 HRM-0016 HRM-0026 HRM-0027 HRM-0028 HRM-0030 HRM-0031 HRM-0032 HRM-0034 HRM-0036 Already replaced at DMTL Shutter new Already replaced at DMTL Shutter new Comment Page 6 of 10 FCI 7814 MEDILAS H UROPULSE WL MEDILAS H UROPULSE WL MEDILAS H UROPULSE WL MEDILAS H UROPULSE WL MEDILAS H UROPULSE WL MEDILAS H UROPULSE WL MEDILAS H UROPULSE WL MEDILAS H UROPULSE WL MEDILAS H UROPULSE WL MEDILAS H UROPULSE WL MEDILAS H UROPULSE WL MEDILAS H UROPULSE WL HRM-0038 HRM-0043 HRM-0044 HRM-0045 HRM-0046 HRM-0048 HRM-0049 HRM-0050 HRM-0056 HRM-0057 HRM-0058 HRM-0059 DMT Japan Dornier Medilas H Solvo MEDILAS H SOLVO WL Time requirement: Manpower: Time schedule: 3 Comment approx. 1.5 hours Modification will be done by the service. Next visit Logistics Material availability: Order of material: 3.1 Serial No. H30-0164 ex stock order processing DMTL with FCI-No., device model and device serial No. Material an Tools Required Amount Designation Standard service tool and measuring instrument for device type Dornier Medilas H Solvo and Dornier Medilas H UroPulse Shutter Dornier Medilas H Solvo Shutter Dornier Medilas H UroPulse Service Manua Dornier Medilas H Solvo, Version D; Service Manua Dornier Medilas H UroPulse, Version C; Page 7 of 10 Stock Number K2013809 K2013810 K2013765 english K2013764 german K2013767 english K2013766 german FCI 7814 4 Perform Modification The software version 1.20 is required. The process is described in the service manual. 1. Bring the device into service position. 2. Remove the EMC Hood. 3. Release the cable of the shutter from the wire harness. 4. Unplug the connector of the shutter from the CPU (X28). 5. Loosen the mounting screws. 6. Replace the complete shutter. Reassemble in reverse order. Page 8 of 10 FCI 7814 5 Perform Final Test 1. Press the shutter plate manually and check, if no collision occurs. 2. Carry out the power tests and functional controls as in the service report described (for service report, see attachment in the service manual). 3. Turn the device 10 times ON/OFF with the power button watch if the shutter reacts correctly. 4. Turn on the device in the therapy mode. Set Single mode (400mJ) and release 30 laser pulses. Thereby, it should be no errors. , If the error occurs again, check the installation of the shutter and repeat the test procedure. 6 Quality Control Quality control is followed by execution of point 5. 7 Documentation 1. 2. 3. The performance of the FCI has to be documented on the FCIFeedback-Form. A copy of the FCI-Feedback-Form has to be filed in the Equipment Book, resp. in the Medical Equipment Book of the hospital. The FCI-Feedback-Form has to be sent immediate to: Dornier MedTech Laser GmbH attn.: Raimund Bischoff Argelsrieder Feld 7 82234 Wessling Germany per fax: +49 8153 888 210 per e-mail: rbischoff@dornier.com Page 9 of 10 FCI 7814 Page 10 of 10 FCI 7814 Dornier MedTech Laser GmbH Argelsrieder Feld 7 D-82234 Wessling Telephone: +49 8153 888-209 Telefax: +49 8153 888-210 FCI 7814 Feedback Equipment Type: Hospital Name: City: Country: SID No.: Serial No.: Service Engineer: Remarks: The performance of the FCI has to be documented on the FCI-Feedback-Form and on the Service Report. The FCI Feedback Form has to be sent to: Dornier MedTech Laser GmbH attn.: Raimund Bischoff Argelsrieder Feld 7 82234 Wessling Germany or per fax: +49 8153 888 210 Date: Signature: