Documentation & Training FCI 7832 Replacement of the Keyboard unit on Dornier Medilas H30 valid for Dornier Medilas H30 Product Subject Priority Qual. Support Date Telephone Telefax eMail : : : : : : : : Dornier Medilas H30 Replacement of Keyboard unit in the event of a fault Raimund Bischoff 07.12.2018 +49 8153 888 209 +49 8153 888 210 rbischoff@dornier.com> Identifier: K2015712 Revision: * The information given herein is confidential and proprietary to Dornier MedTech Company and shall remain confidential for as long as entitled in law. The information is not to be used or disclosed to any party without express written consent of Dornier MedTech Company. All latest approved revisions are located in the network system. All printed hardcopies are for information only FCI 7832 Table of Contents: 1 Reason for Modification .............................................................................. 2 2 Description of Modification .......................................................................... 2 3 Extent of Modification ................................................................................. 2 4 Logistics ...................................................................................................... 3 4.1 Material Required ....................................................................................... 4 4.2 Tools Required ........................................................................................... 4 5 Perform Modification ................................................................................... 4 6 Perform Final Works ................................................................................... 5 7 Quality Control ............................................................................................ 5 8 Hand Over to Customer .............................................................................. 5 9 Documentation............................................................................................ 5 Appendix: FCI 7832-Feedback Form Identifier: K2015712 Revision: * Page 1 of 5 The information given herein is confidential and proprietary to Dornier MedTech Company and shall remain confidential for as long as entitled in law. The information is not to be used or disclosed to any party without express written consent of Dornier MedTech Company. All latest approved revisions are located in the network system. All printed hardcopies are for information only FCI 7832 1 Reason for Modification Defective Keyboard units are reported from the field. The cause is the adhesive cable connection. As a consequence, the change request CR1726 and the FCI 7832 have been created. 2 Description of Modification The FCI 7832 will cover all Dornier Medilas H30 devices manufactured from 01.10.2016. The FCI 7832 only applies to Keyboard units that have been manufactured with an adhesive cable connection. 3 Extent of Modification Systems affected: SN839, SN 848, SN866, SN867, SN868, SN872 – SN1070 Time requirement: approx. 1.5 hours Manpower: Modification will be done by the service. Time schedule: in the event of a fault only IMPORTANT Each sales entity has to check whether one of the affected systems is in its inventory. Page 2 of 5 Revision: * Identifier: K2015712 The information given herein is confidential and proprietary to Dornier MedTech Company and shall remain confidential for as long as entitled in law. The information is not to be used or disclosed to any party without express written consent of Dornier MedTech Company. All latest approved revisions are located in the network system. All printed hardcopies are for information only FCI 7832 4 Logistics Material availability: In accordance with the confirmation of Order-Processing DMT-Laser. Order of material: Order via Order-Processing DMT-Laser with FCI-No. and SN-No. of the affected device. Additional Information: All defective parts must be returned to DMT-Laser together with RGA No. The RGA No. will be assigned by Order-Processing DMT-Laser. The costs for the new Keyboard units will be borne by Dornier MedTech Laser GmbH, if the defect of the corresponding defective Keyboard unit was caused by the adhesive cable connection. The Keyboard units replaced previously, which do not have an adhesive cable connection, are not covered by this FCI. Any other replacement of the Keyboard unit caused by any other reason is not covered by this FCI. The cost of service activities (service technician) on the SBU side must be borne by the SBU. Identifier: K2015712 Revision: * Page 3 of 5 The information given herein is confidential and proprietary to Dornier MedTech Company and shall remain confidential for as long as entitled in law. The information is not to be used or disclosed to any party without express written consent of Dornier MedTech Company. All latest approved revisions are located in the network system. All printed hardcopies are for information only FCI 7832 4.1 4.2 Material Required Amount Designation Mat.-Nr. 1 piece KEYBOARD UNIT H30 SERVICE K2013295 N/A Service Manual Dornier Medilas H30 DE K2014780 Rev. J (Part 1 or Part 2, according to SN) EN K2014781 Rev. J Tools Required Standard service tool and measuring instruments for device type Dornier Medilas H30. 5 Perform Modification The process is described in the service manual DE K2014780 Rev. J / EN K2014781 Rev. J (see chapter 6.4.2.). 1. Bring the device into service position. 2. Dismantle the display unit (chapter 6.4.1.). When opening the fastening screws, pay attention to the compression springs that are attached on the rear of the retaining plates. The compression springs may bounce away lightly (chapter 6.4.2.). 3. Remove the fastening screws (8 x), the compression springs (4 x) and the retaining plates (2 x). 4. Take the display out. 5. Replace the Keyboard unit. 6. Reassemble in the reverse order. 7. Calibrate the Touchscreen. Page 4 of 5 Revision: * Identifier: K2015712 The information given herein is confidential and proprietary to Dornier MedTech Company and shall remain confidential for as long as entitled in law. The information is not to be used or disclosed to any party without express written consent of Dornier MedTech Company. All latest approved revisions are located in the network system. All printed hardcopies are for information only FCI 7832 6 Perform Final Works Perform the Safety Check according to Service Report. The exchanged defective Keyboard unit as well as all regarding documentation has to be sent to the address mentioned in chapter 9. 7 Quality Control Done by completion of section 5 and 6. 8 Hand Over to Customer Hand over the device to the customer. Document the replacement in the Equipment Book, resp. in the Medical Equipment Book of the hospital. 9 Documentation The performance of the FCI 7832 has to be documented on the FCI 7832 -Feedback Form and on the Service Report Form. A copy of the FCI 7832 -Feedback Form has to be filed in the Equipment Book, resp. in the Medical Equipment Book of the hospital. For Dornier MedTech Laser GmbH: The FCI 7832 -Feedback Form must be sent immediately by fax (+49 8153 888 210) or by email (rbischoff@dornier.com) to Dornier MedTech Laser GmbH, Quality Support, Weßling. 4.1 4.2 Material Required ...................................................................................... 4 Tools Required .......................................................................................... 4 Identifier: K2015712 Revision: * Page 5 of 5 The information given herein is confidential and proprietary to Dornier MedTech Company and shall remain confidential for as long as entitled in law. The information is not to be used or disclosed to any party without express written consent of Dornier MedTech Company. All latest approved revisions are located in the network system. All printed hardcopies are for information only Dornier MedTech Laser GmbH Documentation & Training Argelsrieder Feld 7 D-82234 Weßling Telephone: +49 8153 888-209 Telefax: +49 8153 888-210 FCI 7832 Feedback Equipment Type: Hospital Name: City: Country: SID No.: Serial No.: Service Engineer: Remarks: The performance of the FCI 7832 has to be documented on the FCI 7832 -Feedback Form and on the Service Report Form. Put a copy of the FCI 7832 -Feedback Form in the Equipment Book, resp. in the Medical Equipment Book of the hospital. For Dornier MedTech Systems GmbH: The FCI 7832 -Feedback Form has to be sent immediately by fax (+49 8153 888 210) or by email (fmsfeedback@dornier.com) to Dornier MedTech Systems GmbH, Documentation & Training, Weßling. For Dornier MedTech Laser GmbH: The FCI 7832 -Feedback Form has to be sent immediately by fax (+49 8153 888 210) or by email to (rbischoff@dornier.com) to Dornier MedTech Laser GmbH, Quality Support, Weßling. Date: Signature: Identifier: K2015712 Revision: * The information given herein is confidential and proprietary to Dornier MedTech Company and shall remain confidential for as long as entitled in law. The information is not to be used or disclosed to any party without express written consent of Dornier MedTech Company. All latest approved revisions are located in the network system. All printed hardcopies are for information only