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Summary of Contents for ApneBoot

Page 1: ...OPERATION MANUAL TM ...

Page 2: ...right to revise spec ifications and features shown herein or discontinue the product described herein at any time without prior notice or obligation The contents of the document are provided as is Please check with BEMPU representative for the most current information or any query ...

Page 3: ...cts You can find out more at www bempu com Manufactured and Marketed by BEMPU Health Pvt Ltd 3C 3rd Floor Alsa Glenridge Apartment 32 Langford Road Shanti Nagar Bengaluru Karnataka India 560027 BEMPU Customer Support Email Address hello bempu com For India 1 800 425 0192 toll free Or For Whatsapp and Calling 91 9481 841 872 ...

Page 4: ...e BEMPU ApneBoot is subsequently referred to as ApneBoot Pulse Rate as PR and Oxygen Saturation as SpO2 throughout this manual Before using the ApneBoot read the operation manual carefully for a thor ough understanding of the indications contraindications warnings precau tions and safe operation Only qualified service personnel should service this product Caution Rx Only Caution This device should...

Page 5: ...24 4 Troubleshooting 27 4 1 Device 27 4 2 Safety 28 4 3 Warnings and Cautions 29 4 4 Specifications 33 4 5 Guidance and manufacturer s declaration Electromagnetic emissions 36 4 6 Guidance and manufacturer s declaration Electromagnetic immunity 37 4 7 Recommended separation distances between portable and mobile RF communications equipment and device 40 4 8 Symbols for packaging and Instructions 41...

Page 6: ...6 www bempu com ...

Page 7: ...ort by trained medical personnel only It is intended to be used on preterm infants with stimulation and all infants without stimulation ApneBoot identifies apnea through bradycardia and or oxygen desaturation and not by respiration rate NOTE All bradycardia and oxygen desaturation events may or may not coin cide with an apneic event marked by cessation of breathing The ApneBoot is designed to prov...

Page 8: ... Details 1 3 1 Front View of Main Unit 1 Power Button 8 AC Power LED Indicator 2 Stimulator ON OFF Switch 9 Alarm Snooze Button 3 Pulse Oximeter Probe Connector 10 Upward selection Button 4 Stimulator Boot Connector 11 Downward selection Button 5 Snooze LED Indicator 12 Set Button 6 Low Battery LED Indicator 13 History Button 7 Alarm LED Indicator 14 Base Pads 1 3 2 Back View of Main Unit 9 10 11 ...

Page 9: ...The stimulator boot is the vibrating module which is wrapped around the infant s foot sole 1 3 4 Pulse Oximeter Probe The pulse oximeter probe is the sensor that is placed and wrapped around the infant s foot or any peripheral body site suitable for measuring oxygen saturation and pulse rate ...

Page 10: ...10 www bempu com ...

Page 11: ... for service advice to be made to BEMPU Health Pvt Ltd on the given Customer Support number 1800 425 0192 Before operating the ApneBoot check for the following and do not use if there are any signs of damage as described below a Packaging is damaged b Device or any of the accessories are physically damaged c Any of the described box contents are missing The ApneBoot product purchase contains the f...

Page 12: ... 3 Alarm LED blinks RED 4 Stimulator Boot vibrates If you don t find the device turning on please check the power cord and repeat step 1 Call the BEMPU Customer Support number if the problem persists and if the device fails to turn on even after all the connectors are connected as described ii Battery Powered Turn ON the device using the power button given on the front panel If there is enough bat...

Page 13: ...ulator boot should ONLY be placed on the foot sole and not on any other body site WARNING Do not put the stimulator boot if the infant s foot has any skin allergies and is chapped itchy red This may result in aggravation of the allergy WARNING Clean the probes using surgical spirit and cotton swab before placing it against the infant s foot sole Refer to cleaning instructions in Section 5 1 The pu...

Page 14: ...e the pulse oximeter probe on the infant s foot or any peripheral body site suitable for monitoring oxygen saturation and pulse rate and wrap the strap around the site Secure the strap through the two loops and make sure the pulse oximeter probe is fitted snugly Once the pulse oximeter probe is correctly placed onto the foot the screen will display the SpO2 and PR values within 10 seconds If not t...

Page 15: ...he upward and down ward direction of the cursor on the screen The set button helps in setting the different parameters refer to the config uring the settings in section 3 2 On pressing the history button the details of desaturation and bradycardia events are displayed Refer to the History section 3 3 1 2 3 4 Alarm Snooze Button Upward Selection Button Downward Selection Button Set Button History B...

Page 16: ...connector The pulse oximeter probe is connected to the main unit at the pulse oximeter probe connector 3 LEDs When the alarm snooze button is pressed the snooze LED turns RED alert ing the user that the alarm is snoozed When the main unit is battery powered and battery is low the low battery LED turns YELLOW In the event of apnea indicated by bradycardia and or oxygen desaturation Power Button Sti...

Page 17: ...rate on the right most side of the screen in a visibly large size The set threshold value of the oxygen saturation and pulse rate is displayed on the left side of the measured value in a smaller size The stimulation intensity of the stimulator boot set by the user is displayed on the top left corner of the screen The perfusion index quality is displayed on the left side of the screen Oxygen Satura...

Page 18: ... If SpO2 85 AND PR 100 bpm for 5 seconds b If SpO2 75 for 5 seconds c If PR 90 bpm for 5 seconds To select the PRESET mode press the SET button to open the menu screen as shown below Bring the cursor to Preset Mode and press the sub menu Select the ON option by pressing the SET button again Use the downward selection arrow to BACK or EXIT the menu 2 Custom thresholds for SpO2 PR duration of thresh...

Page 19: ...the units position to tens position Further after setting the values go back to the SET menu to set the other values for stimulation intensity volume of the alarm date and time Use the downward selection button to back or exit the menu 3 Stimulation Intensity of the boot can be set at either high medium or low according to the intensity of stimulation required for different infants ...

Page 20: ...can set the date as required Press the SET button when the cursor is pointing at Date on the screen This should display the first screen display on the screen Press the SET button once again to edit the Date and then with the help of the upward and downward selection keys the day month and year can be changed ...

Page 21: ...21 www bempu com 6 The time can be set of the main unit The device uses a 24 hour format for time setting ...

Page 22: ...ide any stimulation 3 3 History Button On clicking the HISTORY button the history of desaturation and bradycardia events is displayed to identify recurring episodes 1 Duration This displays the time in the hh mm format and the ApneBoot can record history upto 12 hours a If the duration displayed is less than 12 hours that means it s the runtime of the main unit b If the duration displayed is 12 ho...

Page 23: ...er button with BEMPU logo is activated LED s Alarm LED blinks Red Audio Audio alarm beeps Stimulator boot vibrates for 1 cycle which includes three sequential vibrations Pulse Oximeter probe not Display Screen shows connected the message Probe not When the Pulse Oximeter Probe Connected is not connected to the main unit LED s No LED Audio No audio alarm Stimulator not connected Display Screen show...

Page 24: ...battery is partially LB next to the discharged battery icon Device is still functional LED s Low Battery LED turns YELLOW Audio No audio alarm Low battery Display Screen shows When the battery is discharged Low Battery along with completely battery icon Device is not fit to be used without further charging LED s Low battery LED blinks YELLOW Audio Audio alarm beeps 3 5 Operational States Normal St...

Page 25: ...e button The visual alarm shown by the RED LED will continue to blink b User should note that the device will stay in snoozed state for 60 seconds after which it automatically resumes the normal operation c The device will continue measuring infant s SPO2 and PR even in snoozed state History a User can view the history of the previously occurred bradycardia and oxygen desaturation events within th...

Page 26: ...26 www bempu com ...

Page 27: ...power button the main unit should indicate the follow ing activation sequences i The BEMPU logo appears ii An audio alarm tone plays iii Alarm LED blinks RED iv Stimulator Boot vibrates 4a If the screen does not turn ON and does not show the BEMPU logo that means the display screen is not working Check the power supply and if the problem persists then contact the BEMPU Customer Support 4b If Alarm...

Page 28: ...rator and ensure correct usage of the device 1 Please keep this operation manual till the end of the ApneBoot usage 2 The Pulse Oximeter Probe Stimulator Boot are critical accessories Clean them every day as per the cleaning instructions given in the section 5 1 in this manual and do not tamper them 3 Keep the main unit and all it s accessories away from water 4 Refer to the cleaning instructions ...

Page 29: ...his may result in ag gravation of the allergy 5 Remove the device strap stimulator boot immediately if it results in any kind of allergy or reaction on the infant foot 6 For next patient user must clean the stimulator boot and pulse oximeter probe as mentioned in the previous section as otherwise it may result in cross contamination or transmission of infection 7 The device detects and alerts by m...

Page 30: ...probes as indicated in section 2 4 Improper placement may lead to no or incorrect readings 17 Place the pulse oximeter sensor probe on a well perfused body site Low perfusion at the monitored site may result in incorrect measurement read ings 18 Do not use ApneBoot on infants injected with dyes or substance contain ing dyes The change in usual blood pigmentation may cause no or incorrect readings ...

Page 31: ...urement include the following exces sive ambient light excessive motion electrosurgical interference blood flow restrictors arterial catheters blood pressure cuffs infusing lines etc moisture in the sensor improperly applied sensor incorrect sensor type poor pulse quality venous pulsations anemia or low hemoglobin concentrations cardiogreen or other intravascular dyes carboxyhemoglobin methemoglo ...

Page 32: ...ications equipment may affect medical electrical equipment 32 Oximeter readings may be affected by the use of an electrosurgical unit ESU 33 The oximeter sensor may not work on cold extremities due to reduced circulation Warm or rub the finger to increase circulation or reposition the sensor 34 A functional tester cannot be used to assess the accuracy of a pulse oximeter monitor or sensor ...

Page 33: ...ength 2m Device dimension H 10cm W 22cm D 7cm Device weight 1 Kg approx Material Enclosure Plastic ABS UL94 V0 FR grade Rubber Parts Biocompatible Silicone as per ISO 10993 Pulse Oximeter Specifications NONIN OEM III Module Oxygen Saturation Range SpO2 0 99 Pulse Rate Range PR 18 to 250 beats per minute bpm SpO2 Accuracy 70 100 No Motion 3 digits Motion 3 digits Low Perfusion 4 digits Pulse Rate A...

Page 34: ...e Settings SpO2 and Pulse Rate threshold for alarm stimulation Stimulation Intensity Level Alarm Volume Level Audio Alarm system as per the EN 60601 1 8 Electrical Power Supply 110 240V AC 50 60Hz Battery Back up Up to 12 hrs 3 5V Alarm volume range 60 90 dB from 1 meter Power Rating 12VA Max Environmental Temperature Operating 0 C to 40 C 32 F 122 F Temperature 0 C to 50 C 32 F Storage Transport ...

Page 35: ... Rating Power Supply CE Certified Battery IEC 62133 Done on the pulse oximeter module Self certified Product Part Ordering Information BEMPU ApneBoot BAB V2 0 Full Product Set Pulse Oximeter Probe MODEL 8001J NEO FLEX SNSR Patient Extension Cable MODEL UNI EXT 1 1M EXT CABLE Pulse Oximeter Probe Strap BAB PS V01 Stimulus Probe BAB SP V01 Stimulator Boot Strap BAB BS V01 ...

Page 36: ...y electronic equipment RF emissions Class B The device is suitable CISPR 11 for use in all establishments including domestic establishments and those directly con nected to the public low voltage network that supplies buildings used for domestic purposes Harmonic Class A Emissions IEC 61000 3 2 Voltage Complies Fluctuations Flicker Emissions IEC 61000 3 3 WARNING The device should not be used adja...

Page 37: ...ial IEC the relative humidity 61000 4 2 should be at least 30 Electrical 2 kV 2 kV Mains power quality fast for power for power should be that of a transient supply supply typical commercial or burst lines lines hospital environment IEC 1 kV 1 kV 61000 4 4 for input for input output output lines lines Surge 1 kV 1 kV Mains power quality IEC line s to line s to should be that of a 61000 4 5 line s ...

Page 38: ...ristic magnetic of a typical location in a field typical commercial or IEC hospital environment 61000 4 8 Conducted 3 Vrms 3 Vrms Portable and mobile RF RF 150 kHz to 150 kHz to communications equip IEC 80 MHz 80 MHz ment should be used no 61000 4 6 closer to any part of the device including ca bles than the recom mended separation distance calculated from the equation ap plicable to the frequency...

Page 39: ...with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the device is used exceeds the applicable RF compliance level above the device should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as r...

Page 40: ...o output power frequency of transmitter m of transmitter W 150 kHz 80 MHz 800MHz to 80 MHz to 800 MHz to 2 5 GHz 0 01 0 12 0 018 0 035 0 1 0 37 0 057 0 11 1 1 17 0 18 0 35 10 3 7 0 57 1 1 100 11 7 1 8 3 5 For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be determined using the equation applicable to the frequency of the transmi...

Page 41: ...torage Temperature This side is up for the packaging Keep away from water Read the instruction manual before use Disposal of the device according to the laws for electronic device disposal Handle with care Made in India Warning Electric shock hazard MADE IN INDIA ...

Page 42: ...42 www bempu com ...

Page 43: ...ng solution doesn t seep inside the device 7 Allow the device to dry prior to operation Probes 1 Clean the pulse oximeter probe sensor before applying it to a new patient 2 Remove the pulse oximeter probe sensor from the patient before cleaning 3 Do not sterilize autoclave or immerse the probes in liquid of any kind Do not pour or spray any liquids onto the probes 4 Do not use caustic or abrasive ...

Page 44: ...he Product is dry and free from any foreign objects or dirt before returning Customer shall care fully pack the Product in the original packaging if possible and hand over to pick up courier of the Company to be shipped to the address listed in BEMPU Customer Support Contact Call BEMPU Customer Support and ask for tech nical or logistical support Enclose a copy of the invoice or the purchase order...

Page 45: ... buyer The Product also includes reusable Nonin pulse oximeter sensors The war ranty period for the said sensors is six 6 months from the date the Product is purchased by the buyer For the stimulator batteries and other accessories sold along with the Prod uct the duration of the warranty shall be six 6 months from the date of purchase by the buyer For the reusable and disposable straps that are s...

Page 46: ...warranty of merchantability fitness for a particular purpose satisfactory quality is implied In no event shall BEMPU s liability arising from any Product or Software under contract warranty tort strict liability or otherwise exceed the amount paid by the buyer for the Product or Software The above limitations do not preclude any liability that cannot legally be disclaimed by contract Exclusions fr...

Page 47: ...ts and these Products are provided AS IS without warranty No Implied License Purchase or possession of this Product confers no express or implied license to use the Product with any unauthorised sensors cables or accessories other than those provided with the Product BEMPU reserves the right to modify amend update this warranty at any time and such modifications amendments and updates shall become...

Page 48: ...BEMPU Customer Support hello bempu com 1 800 425 0192 toll free 91 9481 841 872 2017 BEMPU Health Pvt Ltd All rights reserved ApneBootTM is a registered trademark of BEMPU Health Pvt Ltd ...

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