Cadi Scientific Pte Ltd SMB-800 SmartBridge Instructions For Use Document No.
Cadi Scientific Pte Ltd Document: Document No.: Dept.
Cadi Scientific Pte Ltd Document: Dept. of preparation: Document No.: Revision: Issue Date: Notices Copyright © 2010 Cadi Scientific Pte Ltd. No part of this manual may be reproduced in any form or by any means (including electronic storage and retrieval or translation into a foreign language) without prior agreement and written consent from Cadi Scientific Pte Ltd as governed by international copyright laws. Regulatory Information For customer in the U.S.
Cadi Scientific Pte Ltd Document: Dept. of preparation: Quality Objectives and Quality Planning Control Procedures Revision: Management B01 Representative Issue Date: Document No.: MDDQP-001-A2 28 Oct 2009 Page 4 of 29 Annex II Where you see this symbol on any of our electrical products/packaging in Europe, it means that at end of life the product/battery must be disposed of in accordance with any applicable laws or requirements for the separate disposal of electrical equipment/batteries.
Cadi Scientific Pte Ltd Document: Dept. of preparation: Quality Objectives and Quality Planning Control Procedures Revision: Management B01 Representative Issue Date: Document No.
Cadi Scientific Pte Ltd Document: Dept. of preparation: Quality Objectives and Quality Planning Control Procedures Revision: Management B01 Representative Standards Compliance This SmartBridge meets the following standards Issue Date: Document No.
Cadi Scientific Pte Ltd Document: Dept. of preparation: Quality Objectives and Quality Planning Control Procedures Revision: Management B01 Representative Issue Date: Document No.: MDDQP-001-A2 28 Oct 2009 Page 7 of 29 Annex II 1. Safety 1.1 Safety Information This chapter lists all warnings, attentions and basic safety information when using CADI SMB-800 SmartBridge. Other safety information can be found in appropriate chapters. 1.1.1 Danger There is no safety information on levels of danger. 1.1.
Cadi Scientific Pte Ltd Document: Dept. of preparation: Quality Objectives and Quality Planning Control Procedures Revision: Management B01 Representative Issue Date: Document No.: MDDQP-001-A2 28 Oct 2009 Page 8 of 29 Annex II The packaging material should be disposed according to local regulations and should be kept in a place where no children can reach. Connect CADI SMB-800 only with the provided power adapter. Use with any other adapters may cause serious injuries or death. 1.1.
Cadi Scientific Pte Ltd Document: Dept. of preparation: 1.2 Quality Objectives and Quality Planning Control Procedures Revision: Management B01 Representative Symbols Issue Date: Document No.
Cadi Scientific Pte Ltd Document: Dept. of preparation: Quality Objectives and Quality Planning Control Procedures Revision: Management B01 Representative Issue Date: Document No.: MDDQP-001-A2 28 Oct 2009 Page 10 of 29 Annex II 2. OVERVIEW 2.1 PRODUCT INTRODUCTION 2.1.1 Application range CADI SMB-800 is intended for medical device connection.
Cadi Scientific Pte Ltd Document: Dept. of preparation: Quality Objectives and Quality Planning Control Procedures Revision: Management B01 Representative Issue Date: Document No.: MDDQP-001-A2 28 Oct 2009 Page 11 of 29 Annex II 2.2 PRODUCT VIEW 2.2.1 Front 1. DC power indicator: displays green when dc power adapter is connected. 2. Battery indicator: displays green when running on battery, blinks yellow when battery is low. 3. LCD display: shows information on the 2 line display. 4.
Cadi Scientific Pte Ltd Document: Dept. of preparation: Quality Objectives and Quality Planning Control Procedures Revision: Management B01 Representative Issue Date: 2.2.2 Rear 1. 2. 3. 4. 5. 6. 7. 8. 9. DC power socket. Radio antenna connector. Speaker vent. RS232 port 1: used to connect to other device or PC RS232 port 2: used to connect to other device or PC RS232 port 3: used to connect to other device or PC RS232 port 4: used to connect to other device or PC Wifi antenna connector.
Cadi Scientific Pte Ltd Document: Dept. of preparation: Quality Objectives and Quality Planning Control Procedures Revision: Management B01 Representative Issue Date: Document No.: MDDQP-001-A2 28 Oct 2009 Page 13 of 29 Annex II 3. INSTALLATION AND MAINTENANCE 3.1 INSTALLATION CADI SMB-800 should be installed by authorized personnel. The software of CADI SMB800 belongs to Cadi Scientific Pte Ltd.
Cadi Scientific Pte Ltd Document: Dept. of preparation: Quality Objectives and Quality Planning Control Procedures Revision: Management B01 Representative Issue Date: Document No.: MDDQP-001-A2 28 Oct 2009 Page 14 of 29 Annex II Note Users should have designated personnel to install as needed. Connect adapter 1. Make sure the original adapter and power cord is used. 2. Plug the adapter into the back of the CADI SMB-800 as shown in figure 3-1. 3. Plug the power cord into a wall outlet.
Cadi Scientific Pte Ltd Document: Dept. of preparation: Quality Objectives and Quality Planning Control Procedures Revision: Management B01 Representative Issue Date: Document No.: MDDQP-001-A2 28 Oct 2009 Page 15 of 29 Annex II Connect devices Connect vital sign monitor to port 1,2 or 3. Connect barcode scanner to port 4. 3.1.6 Power on After installation, follow the following steps: 1. Before power on, see 3.1.1 to conduct safety inspection. 2. Press power on/off button.
Cadi Scientific Pte Ltd Document: Dept. of preparation: Quality Objectives and Quality Planning Control Procedures Revision: Management B01 Representative Issue Date: Document No.: MDDQP-001-A2 28 Oct 2009 Page 16 of 29 Annex II 4. The battery power duration reflects the battery performance. If the fully charged battery life is significantly shorter than 6 hours, please contact authorized service personnel to have the battery replaced.
Cadi Scientific Pte Ltd Document: Dept. of preparation: Quality Objectives and Quality Planning Control Procedures Revision: Management B01 Representative Issue Date: Document No.: MDDQP-001-A2 28 Oct 2009 Page 17 of 29 Annex II 3.3 Setting up the device There are some settings to be done before CADI SMB-800 can be used. A few statistics can also be viewed. The figure below shows the menus available to the user. These can be accessed using the Menu button The menus available are: 1. Alarm 2.
Cadi Scientific Pte Ltd Document: Dept. of preparation: Quality Objectives and Quality Planning Control Procedures Revision: Management B01 Representative 07/SEP/09 Scan ID to Start Press Menu button -ALARMON Vol:01 Press Menu button -PORT 1 DEVICEVS300 Press Menu button -PORT 2 DEVICEVS300 Press Menu button -PORT 3 DEVICEVS300 Press Menu button -PORT 4 DEVICEVS300 Issue Date: Document No.
Cadi Scientific Pte Ltd Document: Dept. of preparation: Quality Objectives and Quality Planning Control Procedures Revision: Management B01 Representative Issue Date: Document No.
Cadi Scientific Pte Ltd Document: Dept. of preparation: Quality Objectives and Quality Planning Control Procedures Revision: Management B01 Representative Issue Date: Document No.: MDDQP-001-A2 28 Oct 2009 Page 20 of 29 Annex II 3.4 Using the device CADI SMB-800 has two modes of operation: 1. MANUAL mode; 2. AUTO mode. Both can be entered upon power up or by menu navigation.
Cadi Scientific Pte Ltd Document: Dept. of preparation: Quality Objectives and Quality Planning Control Procedures Revision: Management B01 Representative Issue Date: Document No.: MDDQP-001-A2 28 Oct 2009 Page 21 of 29 Annex II SAVE is selected: The LCD will display upload progress bar. Upload status (upload fail or success) will be shown on screen. REVIEW is selected: The LCD will display the readings and option to SAVE or DISCARD reading.
Cadi Scientific Pte Ltd Document: Dept. of preparation: Quality Objectives and Quality Planning Control Procedures Revision: Management B01 Representative Issue Date: Document No.: MDDQP-001-A2 28 Oct 2009 Page 22 of 29 Annex II 3.4.2 Auto mode Auto mode is used for single patient use e.g. bedside monitoring. When using Auto mode, make sure the connected medical device is also set to Auto mode (refer to the respective user manuals).
Cadi Scientific Pte Ltd Document: Dept. of preparation: Quality Objectives and Quality Planning Control Procedures Revision: Management B01 Representative 3.5 MAINTENANCE Issue Date: Document No.
Cadi Scientific Pte Ltd Document: Dept. of preparation: Quality Objectives and Quality Planning Control Procedures Revision: Management B01 Representative 3.5.2 Cleaning Issue Date: Document No.
Cadi Scientific Pte Ltd Document: Dept. of preparation: Quality Objectives and Quality Planning Control Procedures Revision: Management B01 Representative 3.5.3 Disinfection Issue Date: Document No.
Cadi Scientific Pte Ltd Document: Dept. of preparation: Quality Objectives and Quality Planning Control Procedures Revision: Management B01 Representative Issue Date: Document No.: MDDQP-001-A2 28 Oct 2009 Page 26 of 29 Annex II 4. ALARM 4.1 OVERVIEW Alarms are audio and visual indicators generated by the CADI SMB-800 to alert doctors and nurses. These alarms occur when the vital signs of the patients being monitored become abnormal or the CADI SMB-800 itself malfunctions and cannot perform its task.
Cadi Scientific Pte Ltd Document: Dept. of preparation: Quality Objectives and Quality Planning Control Procedures Revision: Management B01 Representative Issue Date: Document No.: MDDQP-001-A2 28 Oct 2009 Page 27 of 29 Annex II 4.1.3 Alarm modes The alarm modes are: 1. Audio alarm; 2. Visual alarm; 3. Information alarm. These alarm modes indicate alarm levels differently. 4.2 AUDIO ALARM Audio alarm includes alarm sound, key pressing sound and pulse sound.
Cadi Scientific Pte Ltd Document: Dept. of preparation: Quality Objectives and Quality Planning Control Procedures Revision: Management B01 Representative Issue Date: Document No.: MDDQP-001-A2 28 Oct 2009 Page 28 of 29 Annex II 4.3 VISUAL ALARM Yellow light is used for visual alarms. 2Hz flashing yellow light indicates communication error and battery low. Other alarms do not have flashing light. 4.4 ALARM SETTINGS 4.
Cadi Scientific Pte Ltd Document: Dept. of preparation: Quality Objectives and Quality Planning Control Procedures Revision: Management B01 Representative Issue Date: Document No.