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1. Spyder Bluetooth is not design for ST segment analysis Spyder Bluetooth is not intended for use in conjunction of a pacemaker Spyder Bluetooth is not intended for use on infants weighing less than 10 kg Storage Conditions Temperature 25 to 70 C Relative Humidity Up to 93 Pressure Atmospheric pressure of 700 1060 hPa Users are advised to store Spyder Bluetooth in a cool and dry place Using Spyder Bluetooth If Spyder Bluetooth is used for the first time follow the instructions below 1 The following accessories are required to complete the set up a Spyder Bluetooth SPBT20A b 2 x AAA alkaline batteries c Pre loaded Spyder Apps mobile phone with paired connections to Spyder Bluetooth This task must be performed by agent distributor at the point of purchase 2 Load the batteries according to Replacing the batteries Page ee 3 Turn on the Spyder according to Page 14 16 Using Spyder Bluetooth 4 Turn on the Paired Spyder mobile phone with preloaded Spyder apps 5 Follow the instructions of Using Spyder Apps on page 19 21 To Turn On Spyder Bluetooth Step 1 Turn on Spyder Bluetooth by pushing the switch to the ON position Using Spyder Bluetooth Step 2 A green light will illuminate for 2 seconds to indicate that Spyder Bluetooth has been successfully switched on Step 3 Attach the electrode pads to Spyder Bluetooth by sec
2. Detachable Parts Cover The cover can be removed for easy changing of batteries by sliding the cover upwards gently Product Technical Specifications Function Acquisition Sample Rate Dynamic Range Resolution Heart Rate Accuracy Freq Response Common Mode Rejection Input Impedence Patient Leakage Battery Type Battery Voltage Battery Life Battery Included Data Transfer Method Dimensions Operating Temperature Real time ECG monitoring with Bluetooth devices 3 leads 250 per second 2 5 to 7 7mV 10V 1 bpm 0 5 to 25 Hz gt 100dB 50Hz gt 10MQ 10HzQ lt 10pA 2x AAA 3V 3 days per pair No Bluetooth 2 0 26g without batteries 60 x 55 x 18mm 5 to 42 C Product Technical Specifications Operating Relative Humidity 15 to 93 Operating Pressure Atmospheric pressure of 700 1060 hPa Data Analysis Signal Measurements amp Arrhythmia Detection Doctor Spyder Website Data Access User Manual Spyder App for mobile devices Accessories Firmware version SPBT20A_V1 1 Product Life 5 years Heart Rate Calculation Heart rate is calculated with the averaging of 8 beats Pause Calculation PAUSE is determine by continuously comparing the detected RR interval with a preset threshold Safety Precautions and Warnings Please remove batteries inside Spyder Bluetooth when the device is not likely to be used for some time during
3. device is lost Step 6 Start or re enter the application by tapping on the Spyder Application Step 7 To terminate the session simply exit the application Troubleshooting What should do when the app screen goes blank no waveform is seen or the notification alarm on the phone rings Check the Bluetooth connection between your android smartphone and Spyder Bluetooth Ensure the Spyder Bluetooth has working batteries Restart the application by exiting and launching it again The notification alarm will stop ringing when the waveform appears on the phone screen If the waveform does not appear the screen is blank or notification ring tone continues to ring after action 1 2 amp 3 please return the product according to service informa tion section in user manual Troubleshooting What should do if the green indicator light fail to turn on for 2 3 seconds after switching on the Spyder Ensure the Spyder Bluetooth has working batteries Make sure that the phone apps is receiving constant signal from Spyder Bluetooth Ensure that the batteries are inserted according to the indicated polarities If Spyder Bluetooth indicator light still does not turn on after checking with point 1 amp 2 please return the product according to service information section in user manual Troubleshooting What should do if the green indicator light on the Spyder Blue tooth turn off aft
4. transport and before storage to avoid the risk of leakage from batteries Avoid having Spyder Bluetooth in contact with water Spyder does not require to operate in a sterile environment and does not require any deliberate cleaning or maintenance rout However user may clean the external surfaces of the de contamination due to lint or dust using a lint free cloth vice in case of This equipment needs to be installed and put into service in accordance with the information provided in this document No modification of Spyder Bluetooth is allowed This product must be disposed properly accordin regulations Since this product contains a battery disposed separately from household waste ig to local laws and the battery must be Spyder Bluetooth was not evaluated for use in an oxygen rich environment Spyder Bluetooth is not intended for use with flammable anesthetics Safety Precautions and Warnings Spyder Bluetooth is not intended for use in conjunction with flammable agents If the product is received in a damage state do not use Return the product according to service information section in user manual If the on off switch does not work or if the cover of Spyder Bluetooth becomes loose there is no risk to the patient However return the parts according to service information section in user manual In case of Spyder Bluetooth failing to function normally or appearance of phenomenon l
5. 540 27 Certification Statements IP22 is International Protection Rating which classifies and rates the degree of protection provided against the intrusion including body parts such as hands and fingers dust accidental contact and water by mechanical casings and electrical enclosures Spyder is rated as IP22 and is protected against insertion by object larger than 12 5mm in diameter including fingers and vertically dripping water shall have no harmful effect when the enclosure is tilted at an angle up to 15 from its normal posit Legend For Logos An applied part that includes a patient connection that is ntended to deliver electrical energy or an electrophysi ological signal to or from the patient Refer to User Manual for operating instructions Turn On Turn Off Direct current In 2002 the European Uni rical and Electr The directive requires you as en WEEE with the label separately Legal Information This User Manual is published by WEB Biotechnology Pte Ltd without any warrant Improvements and changes to this User Manual necessitated by typographical errors inaccuracies of current information or improvements to equipment may be made by WEB Biotechnology Pte Ltd at any time and without notice Such changes will however be incorporated into new editions of this User Manual All rights reserved WEB Biotechnology Pte Ltd 2012 Publication n
6. SPYDER BLUETOOTH USER MANUAL SPBT20A At WEB Biotechnology we take the responsibility to provide the best medical products to our users This User Manual although sufficient will be constantly updated as our products are im proved Do keep a look out at www web biotech com downloads spyderBT usermanuals Last update 31 Jan 2014 Revision 4 Table of Contents Intended use of Spyder Bluetooth 4 Complementary Products ______ _ 5 Detachable PattS lt s04 cee cece n edema en se dase ee i Product Technical Specifications 7 Safety Precautions and Warnings 9 Storage Conditions lt cccdccccccancqaaecdaacecoasacske Using Spyder Bluetoothi222 2252 esos soe eco eee 19 Replacing the Batteries__________________________ 17 Introduction Intended use of Spyder Bluetooth Spyder Blutooth Intended Use Spyder Bluetooth is a ECG sensor for monitoring of heart rhythm with bluetooth devices It is attached to the chest with an elec trode pad The device is practically inconspicuous when worn providing remarkable quality of life to user Spyder Bluetooth continuously measures and transmits ECG signal to a computer server programmed to identify abnormal heart rhythm patterns It is easy to administer and hassle free to use Spyder Bluetooth truly simplifies the life of user and medical professionals Spyder Bluetooth is intended to be used in the m
7. er lighting up for 2 3 seconds when the switch is in on position Do Not do anything This indicate Spyder Bluetooth in normal operating condition Refer to user manual Using SPYDER Bluetooth Step 2 highlighted the indicator light is design to turn off after 2 3 seconds Make sure that the phone apps is receiving constant signal from Spyder Bluetooth If there is no waveform seen and notification ringtone rings please refer to user manual troubleshoot section Service Information In the case where the device is not functioning as it should be inform your doctor immediately or otherwise contact WEB Biotechnology Pte Ltd at Tel 65 6223 2723 Fax 65 6220 0833 Email info web biotech com Certification Statements FCC Statement For Spyder Bluetooth This device complies with Part 15 of the FCC Rules Operation is subject to the following two conditions 1 this device may not cause harmful interference and 2 this device must p erence received including interference that may cause sired operation This equipment has been tested and found to comply with ts for a Class B tal Device pursuant to Part 15 of the FCC Rules These limits are designed to 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 i
8. ike Spyder Apps screen goes blank no waveform is seen on phone the notification alarm on the phon or the green indicator lights fails to turn on off please follow th tructions in troubleshooting section of the user manual Spyder Bluetooth is intended to be used with biocompatible electrodes with CE mark only in oo Ta The mobile phone with ane pl rnd ae ert be Kept wi ight with Safety Precautions and Warnings Spyder Bluetooth is not intended for use in an environment with stronger than normal magnetic s external electrical influences electrostatic discharge pressure or variations in pressure and acceleration If Spyder Bluetooth is expose under the above unintended operating environment move the Spyder Bluetooth away and normal operating functions should resume without problem In case of uncertainty you may refer to the troubleshooting section of the user manual or consult the manufacturer for guidance Wireless communications equipment like wireless home network devices mobile phones cordless telephones and their base stations walkie talkies can affect this equipment and interfere Spyder Bluetooth equipment For optimum performance Spyder Bluetooth should be kept at least a distance ofo 163m away from the interfering source equipment This equipment is to be operated away from direct light source that will result in an operating environment out of the stated specification in the manual
9. n a particular installation If this equipment does cause harmful interference to radio or television reception which can be determined by turning the radio or television off and on the user is encouraged to try to correct 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 another circuit Consult the dealer or an experienced radio TV technician for help CAUTION Any changes or modifications not expressly approved by the party responsible for compliance could void the user s authority to operate this equipment Certification Statements CE Statement For Spyder Bluetooth C 1304 2280 FCC ID CD9SPBT20A EN 300 328 V1 7 1 Electromagnetic compatibility and Radio spectrum Mat ters ERM Wide band transmission systems Data transmission equipment operating in the 2 4 GHz ISM band and using wide band modulation techniques Harmonised EN covering essential requirements under Article 3 2 of the R amp TTE Directive EN 301 489 17 V2 1 1 Electromagnetic compatibility and Radio spectrum Matters ERM ElectroMagnetic Compatibility EMC standard for radio equipment Part 17 Specific conditions for broadband data transmission systems high performance RLAN equipment and 5 8 GHz broadband data transmitting systems Complies with IDA Standard DB105
10. obile healthcare environment accessed with mobile phone application Information provided are intended only for information to the user Complementary Products Android Smartphone All smartphones running on Android OS with minimum specifica tions of v2 1 Eclair are suitable for hosting the Spyder App The smartphone is provided as accessory by agent representing the product in respective territories Spyder App The Spyder Android App must be installed on the Android smart phone The most updated Spyder App shall be updated by author ized distributor or can be requested to WEB Biotechnology direct ly info web biotech com Healthcare professional and agents installing the Spyder Android App will receive training from WEB Biotechnology Pte Ltd or its authorized representatives Doctor Spyder Server The Doctor Spyder is our server which stores the encrypted ECG data The server can be accessed by authorized medical profes sionals at the url www doctorspyder com For information on how to login and use please refer to Doctor Spyder User Guide Users of Doctor Spyder server will receive training from WEB Biotechnology Pte Ltd or its authorized repre sentatives Electrode Pad For users safety we advise users to use CE certified electrode pad or pads recommended by certified physician User is advised to read the instructions and warning statements of the related electrode pad product for safe operation
11. umber SPBT20A 002 SPYDER Wireless ECG Monitoring System www web biotech com WEB Biotechnology Pte Ltd 35B Mosque Street Singapore 059513 Telephone 65 6223 2723 Fax 65 6220 0833
12. uring the pads to each of the buttons Using Spyder Bluetooth Step 4 Peel off the plastic cover from the elec trode pad and affix Spyder Bluetooth on chest To Turn Off Spyder Bluetooth j Step 1 Switch Spyder Bluetooth off by pushing the switch to the OFF position Replacing the Batteries Step 1 A red light will flash once every 5 seconds to indicate that the batteries need to be replaced soon Step 2 Push open the top cover of Spyder Bluetooth Replacing the Batteries Step 3 Replace 2 AAA batteries as shown Step 4 Replace the top cover of Spyder Bluetooth Using Spyder App Step 1 Launch the Spyder App The Application displays the following information Server Connectivity Battery Indicator Heartbeat Rate _ the problem persists Using Spyder App med line Button Step 3 A marker can be sent to the server by tapping the screen at the area labelled Marker A red line will appear on the screen to indicate successful creation of the marker Step 4 Do not exit the application or the detected ECG may not be trans mitted to the phone and server Simply hide the application while the Spyder Bluetooth is in use Using Spyder App Step 5 The phone will sound when Bluetooth connection with the Spyder Bluetooth

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