Cadi Scientific SMB800 SmartBRIDGE User Manual SMB 800 instructions for use

Cadi Scientific Pte. Ltd. SmartBRIDGE SMB 800 instructions for use

Contents

manual1

      CCaaddii  SScciieennttiiffiicc  PPttee  LLttdd      SSMMBB--880000  SSmmaarrttBBrriiddggee  IInnssttrruuccttiioonnss  FFoorr  UUssee                Document No.:  Established Date: 28 October 2009 Revision: B
CCaaddii  SScciieennttiiffiicc  PPttee  LLttdd  Document:   Document No.:     Dept. of preparation:   Revision:  Issue Date:       Date  Revision  Contents of Revision  Revised by Reviewed by  Approved by28 October 2009  A New Ng Ken Wee    22 September 2010  B Update Ng Ken Wee
CCaaddii  SScciieennttiiffiicc  PPttee  LLttdd  Document:   Document No.:     Dept. of preparation:   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.A and Canada The SMB-800 SmartBRIDGE (FCC ID: VPE-SMB800) has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures: -  Reorient or relocate the receiving antenna. -  Increase the separation between the equipment and receiver. -  Connect the equipment into an outlet on a circuit different from that to which the receiver is connected. -  Consult the dealer or an experienced radio/TV technician for help.  Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) This device must accept any interference received, including interference that may cause undesired operation.  This equipment complies with FCC radiation exposure limits set forth for an uncontrolled environment. End users must follow the specific operating instructions for satisfying RF exposure compliance. This transmitter must not be co-located or operating in conjunction with any other antenna or transmitter.   The lithium battery inside this product contains Perchlorate. The following statement is required by the State of California, USA: Perchlorate Material – special handling may apply.  Changes or modifications not expressly approved by the manufacturer could void the user’s authority to operate the equipment.  For customer in Europe This equipment has been tested and found to comply with the limits set out in the R&TTE Directive.
CCaaddii  SScciieennttiiffiicc  PPttee  LLttdd  Document:  Quality Objectives and Quality Planning Control Procedures  Document No.:    MDDQP-001-A2 Dept. of preparation:  Management Representative  Revision: B01  Issue Date:   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.
CCaaddii  SScciieennttiiffiicc  PPttee  LLttdd  Document:  Quality Objectives and Quality Planning Control Procedures  Document No.:    MDDQP-001-A2 Dept. of preparation:  Management Representative  Revision: B01  Issue Date:   28 Oct 2009  Page 5 of 29 Annex II  Product Information   Product model: CADI SMB-800   Product name: SmartBridge   Manufacturing site: 31 Ubi Road 1, #03-00 Aztech Building, Singapore 408694  Version Information   This version is subject to change or upgrade without notice  Version: A01   Issue date: xxxxxxxx  Declaration Cadi Scientific Pte Ltd reserves the right to change the product described in this Operating Manual. All information contained in this Operating Manual is subject to change without prior notice.  Manufacturer’s Responsibility Cadi Scientific is responsible for the safety, reliability and performance of the device under the following conditions: Assembling, upgrading, resetting and repairing are performed by Cadi’s authorized personnel. Operating this device following this manual. Product serial number and labels are intact to verify the product identity as manufactured by Cadi Scientific Pte Ltd. Product storing environment, operating environment and electrical environment are as described in this manual. Damages not by misuse of accidental dropping.  Free services apply to products with applicable items within warranty period. For products beyond the description of warranty conditions, service charge applies. Customers are required to pay for any transportation and applicable customs fees of returned goods to Cadi Scientific.  Return Proceedures If return is necessary, take the following steps: 1.  Obtain return goods authorization from Cadi Scientific Customer Service Department. Inform Cadi Scientific of the serial number and mark this serial number on the cartons. If the serial number cannot be recognized, the return cannot be accepted. Describe briefly the reasons for return. 2.  Frieght Charge: customer is responsible for freight charges (including customs) for any returns.
CCaaddii  SScciieennttiiffiicc  PPttee  LLttdd  Document:  Quality Objectives and Quality Planning Control Procedures  Document No.:    MDDQP-001-A2 Dept. of preparation:  Management Representative  Revision: B01  Issue Date:   28 Oct 2009  Page 6 of 29 Annex II  Standards Compliance This SmartBridge meets the following standards
CCaaddii  SScciieennttiiffiicc  PPttee  LLttdd  Document:  Quality Objectives and Quality Planning Control Procedures  Document No.:    MDDQP-001-A2 Dept. of preparation:  Management Representative  Revision: B01  Issue Date:   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.  1.1.2 Warning  Only professional doctors and nurses can use this CADI SMB-800 for clinical monitoring under certain conditions.  Before using CADI SMB-800, users must check the device and its accessories to ensure its proper function and safety.  Disposable accessories should be disposed according to the regulations of the hospital.  Do not use CADI SMB-800 in an environment where flammable substances are present.  Users should set alarm settings according to patient types and conditions.  Do not open CADI SMB-800 case. Otherwise, it may cause serious injuries or death.  Do not use on patients during defibrillation. Otherwise, it may cause serious injuries or death.  Ensure patient safety when using CADI SMB-800 with other electrical surgical devices.
CCaaddii  SScciieennttiiffiicc  PPttee  LLttdd  Document:  Quality Objectives and Quality Planning Control Procedures  Document No.:    MDDQP-001-A2 Dept. of preparation:  Management Representative  Revision: B01  Issue Date:   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.  1.1.3 Caution  Use accessories recommended in this manual to ensure patient safety.  Magnetic fields may affect the performance of CADI SMB-800. Any equipment in use near CADI SMB-800 must be in compliance with EMC standards. Cell phones, X-ray or MRI devices are possible interference sources, as they emit high electro-magnetism radiation.  Before connecting CADI SMB-800 to power, ensure the voltage and frequency are in accordance with the requirements on the adapter label or in the manual.  Install and transport CADI SMB-800 properly to prevent any damages caused by dropping, impact, shakes or other mechanical forces.  This equipment should be installed and operated with minimum distance 20cm between the radiator & your body.   1.1.4 Note Note Place this manual next to the CADI SMB-800 for convenience when needed.  The software for the CADI SMB-800 is developed in accordance with IEC60601-1-4 standards to minimize any risks caused by program errors.  Up to 1000 trend data storage.  Place CADI SMB-800 where easy observation, operation and maintenance can be obtained.
CCaaddii  SScciieennttiiffiicc  PPttee  LLttdd  Document:  Quality Objectives and Quality Planning Control Procedures  Document No.:    MDDQP-001-A2 Dept. of preparation:  Management Representative  Revision: B01  Issue Date:   28 Oct 2009  Page 9 of 29 Annex II  1.2 Symbols
CCaaddii  SScciieennttiiffiicc  PPttee  LLttdd  Document:  Quality Objectives and Quality Planning Control Procedures  Document No.:    MDDQP-001-A2 Dept. of preparation:  Management Representative  Revision: B01  Issue Date:   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. It is intended to connect to devices such as non-invasive blood pressure monitors (NIBP), oxygen saturation of arterial hemoglobin (SpO2) meters, pulse rate monitors, temperature monitors, and other Vital Signs Monitors.   2.1.2 Product structure CADI SMB-800 is composed of the main unit, and adapter power supply/charger.  CADI SMB-800 has the following functions and features: 1.  Connecting up to four (4) medical devices to the RS232 communication ports. 2.  Receiving ThermoSensor data thru the built-in radio. 3.  Upload data thru Wifi 802.11b/g or radio to hospital infrastructure. 4.  Display: LCD and LED 5.  Battery: internal rechargeable lithium battery, coin cell backup battery.
CCaaddii  SScciieennttiiffiicc  PPttee  LLttdd  Document:  Quality Objectives and Quality Planning Control Procedures  Document No.:    MDDQP-001-A2 Dept. of preparation:  Management Representative  Revision: B01  Issue Date:   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.  Manual mode indicator: displays “Manual” in red when device is in Manual mode. 5.  Port 1 indicator: displays green when device connected and working properly. Flashes yellow when there is error in this communication port. 6.  Port 2 indicator: displays green when device connected and working properly. Flashes yellow when there is error in this communication port. 7.  Port 3 indicator: displays green when device connected and working properly. Flashes yellow when there is error in this communication port. 8.  Port 4 indicator: displays green when device connected and working properly. Flashes yellow when there is error in this communication port. 9.  Wifi indicator: displays green when active, flashes green when communicating, flashes yellow when error. 10. Radio indicator: displays green when active, flashes green when communicating, flashes yellow when error. 11. Memory indicator: flashes green when communicating, flashes yellow when nearing full. 12. Alarm  indicator:  flashes yellow when alarm condition. 13. Power button: press and hold for at least 2 seconds to turn the CADI SMB-800 on or off. 14.  Auto mode indicator: displays “Auto” when device is in Auto mode. 15.  Battery charge indicator: indicates battery is charging and quantity of battery electric charge. 16.  Menu button: used in combination with Select button to navigate menus and settings. 17.  Select button: used in combination with Menu button to navigate menus and settings.
CCaaddii  SScciieennttiiffiicc  PPttee  LLttdd  Document:  Quality Objectives and Quality Planning Control Procedures  Document No.:    MDDQP-001-A2 Dept. of preparation:  Management Representative  Revision: B01  Issue Date:   28 Oct 2009  Page 12 of 29 Annex II  2.2.2 Rear   1.  DC power socket. 2.  Radio antenna connector. 3. Speaker vent. 4.  RS232 port 1: used to connect to other device or PC 5.  RS232 port 2: used to connect to other device or PC 6.  RS232 port 3: used to connect to other device or PC 7.  RS232 port 4: used to connect to other device or PC 8.  Wifi antenna connector. 9.  Common potential terminal (unused)
CCaaddii  SScciieennttiiffiicc  PPttee  LLttdd  Document:  Quality Objectives and Quality Planning Control Procedures  Document No.:    MDDQP-001-A2 Dept. of preparation:  Management Representative  Revision: B01  Issue Date:   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 SMB-800 belongs to Cadi Scientific Pte Ltd. No one should, in any manner, alter, copy or exchange the software without prior permission from Cadi Scientific Pte Ltd.
CCaaddii  SScciieennttiiffiicc  PPttee  LLttdd  Document:  Quality Objectives and Quality Planning Control Procedures  Document No.:    MDDQP-001-A2 Dept. of preparation:  Management Representative  Revision: B01  Issue Date:   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.  Warning Do not plug the into a socket controlled by a switch. Do not use an adapter plug, use the correct power cord for your country.
CCaaddii  SScciieennttiiffiicc  PPttee  LLttdd  Document:  Quality Objectives and Quality Planning Control Procedures  Document No.:    MDDQP-001-A2 Dept. of preparation:  Management Representative  Revision: B01  Issue Date:   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. System conducts self test automatically (POST).  Note During self test (POST), make sure all displays and indicators illuminate.  3.  In the self test (POST), display testing takes about 2 seconds. All indicators illuminate; All LEDs illuminate; The LCD light illuminates and the welcome screen is shown.  Note If there are any indicators or displays that do not illuminate, do not use CADI SMB-800. Contact sales or service representatives.  4.  After self test for display functions, the welcome screen in the LCD will display the software version.  The battery might be drained during transportation or storage. If the CADI SMB-800 has been stored for more than 2 months, it is necessary to re-charge the battery before use by plugging the CADI SMB-800 into an AC power outlet for at least 30 minutes.  Regardless whether the CADI SMB-800 is powered off or on, the battery will be fully charged in about 6 hours if the AC power is connected to the CADI SMB-800.  Note Whenever CADI SMB-800 is connected to AC power, the battery will be charged. Please keep CADI SMB-800 connected with the AC power even when it is not in use to ensure a fully charged battery. A connected unit will show the DC power indicator in green.  When using CADI SMB-800 without sufficient battery power, plug CADI SMB-800 into AC power outlet to charge the battery. CADI SMB-800 can be switched on for normal use.  3.2.2 Inspect battery performance The battery performance may decrease as the time goes by. Follow the following steps to inspect the battery performance: 1.  Disconnect all connections between CADI SMB-800 and other devices. Stop all activity. 2.  Connect CADI SMB-800 with AC power and keep charging the battery for more than 6 hours. 3.  Disconnect the DC adapter and use the CADI SMB-800 with battery power till the CADI SMB-800 shuts off.
CCaaddii  SScciieennttiiffiicc  PPttee  LLttdd  Document:  Quality Objectives and Quality Planning Control Procedures  Document No.:    MDDQP-001-A2 Dept. of preparation:  Management Representative  Revision: B01  Issue Date:   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.  Note The life of the battery depends on frequency of usage and duration. With proper maintenance and charge, the normal battery life is about 3 years. Otherwise, the battery life can be shorter. Replacing the battery every 3 years is recommended. The battery power duration depends on CADI SMB-800 set and operation. For example, many connected devices or frequent measuring can shorten the power duration.  3.2.3 Battery disposal If there is obvious damage to the battery, replace the battery immediately. Dispose the battery properly according to local regulations.  Note Please contact authorized service personnel to have the battery replaced.  Warning Contact manufacturer at the time to replace the battery which should be replaced by authorized personnel. Do not place the battery near or in fire. Burning, explosion or leakage may cause injuries.
CCaaddii  SScciieennttiiffiicc  PPttee  LLttdd  Document:  Quality Objectives and Quality Planning Control Procedures  Document No.:    MDDQP-001-A2 Dept. of preparation:  Management Representative  Revision: B01  Issue Date:   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   and Select button   to navigate.  The menus available are: 1. Alarm   On/Off, Volume 2. Port x Device    (nothing to set) 4. Upload Mode    Manual/Auto 5. Set Interval    Hours, Minutes (for Auto mode only) 5. Date setting    dd/mth/yy/day of week 6. Time setting    hh:mm, AM/PM 7. Readings saved    Number of records stored (nothing to set) 8. Maintenance mode  (password protected, for service personnel only)
CCaaddii  SScciieennttiiffiicc  PPttee  LLttdd  Document:  Quality Objectives and Quality Planning Control Procedures  Document No.:    MDDQP-001-A2 Dept. of preparation:  Management Representative  Revision: B01  Issue Date:   28 Oct 2009  Page 18 of 29 Annex II   07/SEP/09        Scan   ID   to   Start ID: S90lP06YA Press    to Abort -PORT 1 DEVICE-  VS300 -PORT 2 DEVICE-  VS300 -PORT 3 DEVICE-  VS300 -PORT 4 DEVICE-  VS300 -ALARM- ON        Vol:01  Press Menu button  Press Menu button  Press Menu button  Press Menu button  Press Menu button
CCaaddii  SScciieennttiiffiicc  PPttee  LLttdd  Document:  Quality Objectives and Quality Planning Control Procedures  Document No.:    MDDQP-001-A2 Dept. of preparation:  Management Representative  Revision: B01  Issue Date:   28 Oct 2009  Page 19 of 29 Annex II   UPLOAD MODE MANUAL Set Interval 0Hours         30Minutes -DATE- 07/SEP/2010    THU -TIME- 02:38  PM -Readings saved- 1000 set saved -MAINTENANCE- ENTER Press Menu button Press Menu button Press Menu button Press Menu button Press Menu button Press Menu button  Note: For AUTO mode only
CCaaddii  SScciieennttiiffiicc  PPttee  LLttdd  Document:  Quality Objectives and Quality Planning Control Procedures  Document No.:    MDDQP-001-A2 Dept. of preparation:  Management Representative  Revision: B01  Issue Date:   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.   Upon power up:     Using menu navigation:    Use the Menu button   and Select button   to navigate.  3.4.1 Manual mode  Manual mode is used for spot measurement. Once Manual mode is selected, the “Manual” word will light up and the LCD will show the following screen:    Before each measurement, the user has to scan the ID with the barcode scanner. Once the barcode is scanned, the next screen will show:    After this, activate the attached medical device (refer to the appropriate user manual). If at any time the user wants to abort, just select ESC and press button   here. Otherwise, navigate to SAVE to save and upload reading, or REVIEW to look at the results.   Set Mode   MANUAL  AUTO 07/SEP/09        Scan   ID   to   start ID: S90lP06YA SAVE  REVIEW  ESC UPLOAD MODE MANUAL
CCaaddii  SScciieennttiiffiicc  PPttee  LLttdd  Document:  Quality Objectives and Quality Planning Control Procedures  Document No.:    MDDQP-001-A2 Dept. of preparation:  Management Representative  Revision: B01  Issue Date:   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.      ESC is selected: last measurement is discarded and screen returns to default display:    If something did not go smoothly, the screen below will flash:    If everything goes as normal and the measurement is successfully completed, the next screen will return to the default display:     07/SEP/09        Scan   ID   to   start NO MEASUREMENT Save Measurement?       Save         Abort √P1: SYS 120 √P1: DIA 80 07/SEP/09        Scan   ID   to   Start
CCaaddii  SScciieennttiiffiicc  PPttee  LLttdd  Document:  Quality Objectives and Quality Planning Control Procedures  Document No.:    MDDQP-001-A2 Dept. of preparation:  Management Representative  Revision: B01  Issue Date:   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). Once Auto mode is selected, the “Auto” word will light and the LCD will show the following screen:    The user can set the interval for data upload here. Use the Menu button   for changing the values and Select button   for confirmation. This setting is stored in non-volatile memory. Upon confirmation, the next screen will show the default display:    Once the ID has been scanned via the barcode scanner, the next screen will show:    If the connected medical devices have also been set for Auto mode, no further action is necessary. The device will activate measuring at the specified interval.   ID: S90lP06YA SAVE  REVIEW  ESC 07/SEP/09        Scan   ID   to   Start Set    Interval   0Hours    30Mins
CCaaddii  SScciieennttiiffiicc  PPttee  LLttdd  Document:  Quality Objectives and Quality Planning Control Procedures  Document No.:    MDDQP-001-A2 Dept. of preparation:  Management Representative  Revision: B01  Issue Date:   28 Oct 2009  Page 23 of 29 Annex II  3.5 MAINTENANCE
CCaaddii  SScciieennttiiffiicc  PPttee  LLttdd  Document:  Quality Objectives and Quality Planning Control Procedures  Document No.:    MDDQP-001-A2 Dept. of preparation:  Management Representative  Revision: B01  Issue Date:   28 Oct 2009  Page 24 of 29 Annex II  3.5.2 Cleaning
CCaaddii  SScciieennttiiffiicc  PPttee  LLttdd  Document:  Quality Objectives and Quality Planning Control Procedures  Document No.:    MDDQP-001-A2 Dept. of preparation:  Management Representative  Revision: B01  Issue Date:   28 Oct 2009  Page 25 of 29 Annex II  3.5.3 Disinfection
CCaaddii  SScciieennttiiffiicc  PPttee  LLttdd  Document:  Quality Objectives and Quality Planning Control Procedures  Document No.:    MDDQP-001-A2 Dept. of preparation:  Management Representative  Revision: B01  Issue Date:   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.  4.1.1 Alarm types The alarms are Technical Alarm and Information Prompt.   Technical Alarm Technical Alarm means the device or parts are not capable to perform the monitoring task, e.g. device failure.   Information Prompt Strictly speaking, Information Prompt is not a type of alarm. The CADI SMB-800 can display some information of the system status, e.g. battery low. This type of information is not related to device failure.  4.1.2 Alarm levels There are 3 levels of alarm: High, Mid and Low.   High level alarm High level alarm indicates life threatening or serious technical problems of the CADI SMB-800.    Mid level alarm Mid level alarm occurs when preset thresholds are exceeded.    Low level alarm The following situations will prompt low level alarms: 1.  CADI SMB-800 malfunction; 2.  Battery low (when using battery for power supply); 3.  Medical device connection lost.  When battery is low, the indicator will illuminate and there will be sound. All Technical Alarms are default settings which cannot be changed.
CCaaddii  SScciieennttiiffiicc  PPttee  LLttdd  Document:  Quality Objectives and Quality Planning Control Procedures  Document No.:    MDDQP-001-A2 Dept. of preparation:  Management Representative  Revision: B01  Issue Date:   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.  Note When various levels of alarm occur at the same time, alarm sound indicates the high level alarm.  Table 4-1 Alarm Sound Functions Function Explanation  Volume  Frequency(Hz)  Width Td(ms) Interval Ts(ms)  Number of sounds Self test passed  Power-on self test completed, one sound indicates the test passed. Cannot be adjusted  1500 150 N/A One “beep” Valid key pressing  One sound indicates the key pressing is valid. Cannot be adjusted  400 150 N/A One “beep” High level alarm  One high note sound with rapid “beep” Adjustable 700  150  N/A  “beep-beep-beep—beep-beep, beep-beep-beep—beep-beep” Mid level alarm  Two mid, stable beeps  Adjustable 700  150  200  “beep-beep-beep” Low level alarm  One low, slow beep  Adjustable 700  150  N/A  One “beep”
CCaaddii  SScciieennttiiffiicc  PPttee  LLttdd  Document:  Quality Objectives and Quality Planning Control Procedures  Document No.:    MDDQP-001-A2 Dept. of preparation:  Management Representative  Revision: B01  Issue Date:   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  4.5 AUDIO ALARM STATUS Under normal working conditions, all alarm modes for all levels of alarms can be performed. The user can also set alarms to meet their requirements. The alarm settings can be accessed from the menu. Note that High level alarms cannot be disabled.  Normal audio alarms When alarms occur, there is a normal alarm sound.  Alarm sound setting Alarm sound OFF means the sound is silenced. Under the menu, navigate to Alarm screen and select OFF.   -ALARM- OFF        Vol:01
CCaaddii  SScciieennttiiffiicc  PPttee  LLttdd  Document:  Quality Objectives and Quality Planning Control Procedures  Document No.:    MDDQP-001-A2 Dept. of preparation:  Management Representative  Revision: B01  Issue Date:   28 Oct 2009  Page 29 of 29 Annex II  SPECIFICATIONS  Power  100 - 240 V AC, 50/60 Hz Power consumption  Max 40VA External dimensions (excluding maximum projecting part) 170 x 280 x 40 mm Internal battery pack  12.6v Li-Ion (SHENZHEN CHAM BATTERY CMICR18650) Clock backup battery  3v Li-Mn cell CR2450 Mass  Approx. 1.2 kg (2.6 lb) Operating temperature  20°C - 40°C (68°F - 104°F) Storage temperature  10°C - 50°C (50°F - 122°F) Transport temperature  10°C - 50°C (50°F - 122°F) Inputs/outputs  DC connector x1 DB9F x4 Supplied accessories  DC adapter x1 (SKYNET SNP-A048-M) AC cable x1 DB9 cable x1 Instruction manual x1 Transmission frequency  868.4 MHz (For customer in Europe) 919.8 MHz (For customer in U.S.A) 925.0 MHz (For customer in U.S.A) 2.4 Ghz (For customer in Europe and U.S.A)

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