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Summary of Contents for Sentec SDM
- Page 1 Sentec Digital Monitoring System Installation at Home User Site by Instructed Personnel...
- Page 2 Note: Installation of the SDMS including configuration of the monitor (SDM) shall only be performed by an instructed person from a homecare provider. This instructed person must have received the appropriate training by a Sentec AG representative. SDMS-related tutorials are available for online viewing at http://www.sentec.com/tv...
- Page 3 Note: The patient as lay operator cannot modify the SDM’s configuration by using the SDM’s menu. If the SDMS has been stored below 10 °C / 50 °F, it must be acclimatized for two hours at room temperature before it can be connected to the mains or switched on. The SDMS may not be installed and operated in moist rooms (e.g.
- Page 4 Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the SDM, including cables specified by the manufacturer. Wireless mobile devices must be held away from the SDMS by at least 1 m (39.4 inches).
- Page 5 The menu access of the monitor must be disabled in V-STATS™ to avoid patients changing monitor settings accidently or on purpose. Either select the preconfigured SDM Home Profile of V-STATS™ or follow the below steps: Switch off auditory alarm signals permanently using V-STATS™.
- Page 6 Instructions for connecting the Isolation Transformer (REF: RFT100VA-V1 and RFT100VA-V2) Classification The monitor SDM is a Class I ME equipment and IPX1 according to IEC 60601-1. The Isolation Transformer is an additional MOPP according to IEC 60601-1-11. Technical data Isolation Transformer...
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Page 7: Connecting The Isolation Transformer
The Isolation Transformer (RFT100VA-V1 and RFT100VA-V2) is intended for use only with the Sentec Digital Monitor (SDM). Any modification to the Isolation Transformer, to the SDM or to the installation procedure as described in this manual, may result in physical injury, inaccurate measurements, and/or damage to the device. - Page 8 Plug the SDM mains cable into the wall socket. Do not use extension cables or multipliers. Ensure that the mains connection can be easily disconnected from the mains supply. Note: As an additional means of protection, Sentec recommends to perform a socket and wiring test prior to use (see Annex).
- Page 9 Disconnect mains supply plug from the wall socket. Open the Water Protection Box, remove and disconnect the cables (C13, C14). Disconnect the isolation transformer from the SDM. Sentec AG, Ringstrasse 39, CH-4106 Therwil, Switzerland, www.sentec.com HB-010103-e Date of release: 01/2022...
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Page 10: Maintenance
3. Maintenance Note: Instructed personnel/homecare providers must not repair the Isolation Transformer. If the Isolation Transformer is defective, please contact qualified service personnel or your local Sentec representative. Expected Useful Life of electrical devices: Product Name Expected Useful Life Sentec Digital Monitor... -
Page 11: Routine Checks
Digital Monitor (mandatory). Cleaning/Disinfection For cleaning and/or disinfecting the SDM, the TC Sensors and the Digital Sensor Adapter Cable, please refer to www.sentec.com/ifu. For cleaning the Isolation Transformer, use a dry or damp cloth. For disinfection, use a 70% isopropanol moistened wipe. - Page 12 4. Annex: Instructions for socket and wiring testing (recommended) As an additional means of protection, Sentec recommends performing a socket and wiring test prior to SDMS installation to verify proper socket installation. The socket testing procedure must only be carried out by a homecare provider’s instructed person.
- Page 13 Brand Name Manufacturer voltage Socket Tester F + E (CEE 7/7) 230 V/AC 50Hz Voltcraft VC40 Conrad Electronic International Compatible to GmbH & Co. KG Schuko plug www.conrad.com Sentec AG, Ringstrasse 39, CH-4106 Therwil, Switzerland, www.sentec.com HB-010103-e Date of release: 01/2022...
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Page 14: Glossary Of Symbols
Note: By recycling materials or other forms of utilizing old devices, you are making an important contribution to protecting our environment. Sentec AG, Ringstrasse 39, CH-4106 Therwil, Switzerland, www.sentec.com HB-010103-e Date of release: 01/2022... - Page 15 Indicates a medical device that needs to be protected from moisture. Atmospheric pressure Indicates the atmospheric pressure limits to which the medical device can limitation be safely exposed. Sentec AG, Ringstrasse 39, CH-4106 Therwil, Switzerland, www.sentec.com HB-010103-e Date of release: 01/2022...
- Page 16 Sentec AG, Ringstrasse 39, CH-4106 Therwil, Switzerland, www.sentec.com HB-010103-e Date of release: 01/2022...
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