Bempu ApneBoot Manuel utilisateur
OPERATION MANUAL
TM
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Disclaimer
All rights reserved. BEMPU Health Pvt. Ltd. reserves the right to revise spec-
ications 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.
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About the company
BEMPU Health Pvt Ltd. provides a range of innovative and high-quality infant
healthcare products. You can nd 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: [email protected]
For India 1 (800) 425 0192 (toll free)
Or
For Whatsapp and Calling +91 - 9481 841 872
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ABOUT THE MANUAL
This manual contains necessary information for safe and proper setup and
use of the BEMPU ApneBoot device. Important safety information relating to
general use of the BEMPU ApneBoot is conveyed in this manual.
The 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 qualied service personnel should service this
product.
Caution: Rx Only.
Caution: This device should be used by trained medical personnel only.
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CONTENTS
1. Product Description 7
1.1 Indications for Use and Contraindications 7
1.2 Declaration of Substances Usage 8
1.3 Device Details 8
2. Device Setup 11
2.1 Unpacking and Inspection 11
2.2 Setup 11
2.3 Preparation for Use 12
2.4 Method of Probe Placement 13
3. Operation 15
3.1 Main Screen 15
3.2 Conguring the Settings 18
3.3 History Button 22
3.4 Alarms and Indications 23
3.5 Operational States 24
4. Troubleshooting 27
4.1 Device 27
4.2 Safety 28
4.3 Warnings and Cautions 29
4.4 Specications 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
5. Service and Maintenance 43
5.1 Cleaning 43
5.2 Repair Policy 44
5.3 Return Procedure 44
5.4 Disposal of Device 44
BEMPU Customer Support Contact Details 45
Warranty 45
Exclusions from Warranty 45
No Implied License 47
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1. PRODUCT DESCRIPTION
BEMPU ApneBoot is a pulse oximeter-based device that helps primary
apneas. It uses an inbuilt pulse-oximeter to monitor oxygen saturation and
pulse rate. In the event of apnea, as indicated by bradycardia and/or oxygen
desaturation, it uses a stimulator that vibrates the foot sole of the infant, to
stimulate the nervous system to restart breathing. The device also provides
an audio-visual alarm to get the caretakers attention to rapidly intervene
before any injury can occur.
The device operates on alternating current and also has an inbuilt battery to
provide a power backup of up to 12 hours.
1.1 Indications for Use and Contraindications
ApneBoot is intended to be used in clinical settings and mobile environments
like inter and intra-hospital transport, by trained medical personnel only. It
is intended to be used on preterm infants (with stimulation) and all infants
(without stimulation).
ApneBoot identies 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 provide safe stimulus to help resolve primary
apneas which are central in nature. It cannot resolve secondary or obstruc-
tive apneas.
The device is not intended to be used with highly critical infants who are kept
on ventilator support and/or any life support devices.
The device is not designed to be used at home and/or by any non-clinical
untrained sta.
Do not use this device in an MR environment.
Explosive Hazard: Do not use this device in an explosive atmosphere or in the
presence of ammable anesthetics or gases
This device does not meet debrillation-proof requirements per IEC 60601-1.
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1.2 Declaration of Substances Usage
ApneBoot is a non-invasive device and does not include any bio-substances
or tissue derivatives. The product is intended to be used in clinical settings
like hospitals.
1.3 Device 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
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10
11
12
13
5 6 7 8 1
2
4 3
14
15
14
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14. AC Power ON/OFF Switch
15. AC Power Cord Connector
1.3.3 Stimulator Boot
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.
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