Neurotronics BP01 Body Position Sensor Instructions

BPO1 Body Position Sensor Instructions For Use (Rev. 23072801)

Intended Uses & Features

The RIP and Body Position Sensors areintended to measure and output respiratory effort signals and body position, respectively, from a patient for archival in @ polysomnography study. The sensors are accessories to a polysomnography system which records and conditions the physiological signals foranalysis and display, such that the data may be analyzed by 2 qualified sleep clinician to aid in the diagnosis of sleep disorders.
The RIP and Body Position Sensors areintended for use on both adults and children by healthcare professionals within a hospital, laboratory, clinic, or nursing home; or outside of a medical facility under the direction of a medical professional.
The RIP and Body Position Sensors are not intended for the life monitoring of high risk patients, do not include or trigger alarms, and arenot intended to be used as a critical component of:

• an alarm or alarm system;
• an apnea monitor or apnea monitoring system; or
• life monitor or ife monitoring system.

Symbol Descriptions

| Body Position Orientation Symbol
---|---
| Unique Device Identifier: GS1 formatted 20 barcode
(01) Device identifier
(11) Manufacturing/ Production Date: YYMMDD
(21) Serial Number

Setup and Function

1. Place a respiratory belt (such as the Neurotronics RIP Belt) around either the patient’s chest or abdomen.
2. Position sensor 5o that the Body Position Orientation Symbolis in the same orientation as the patient
3. Wrap the hook and loop strap of the sensor around the center of the respiratory bett
4. The sensor should be positioned on the front of the patient, along the center line of their body.
5. Ensure the sensor s firmly in place and does not slide or rotate around the belt
6. Plugthe output connector into a recorder.

Note: When disconnecting from the amplifier, grasp the connectors firmly. Do not pull on the wire leads as this can damage the connectors. Damage caused by pulling on the wire leads is not covered under warranty.
The P01 Body Position sensor uses an accelerometer to detect the orientation it is in.
It detects upright, ight side down, left side down, prone, and supine positions. Check that these outputs match the patient’s orientation prior to starting the sleep study.

Cleaning

Clean and inspect device for damage before each use.
To clean sensor, wipe the plastic enclosure, strap, and wire set with one of the following

• Soft cloth and mild detergent
• Soft cloth and 70% sopropyl alcohol
• Soft cloth and Bleach solution containing 0.6% Sodium Hypochlorite
• Metrex Cavi-Wipe
• PDI Sani-Cloth Bleach Wipe
• PDI Super Sani-Cloth Wipe

To disinfect the sensor, follow the cleaning solution’s instructions or recognized standards for disinfection.
DO ot immerse the sensor in cleaning solution or allow liquid to get into any openings. Immersing the sensor will damage the device and void the product warranty.
Ensure the sensor is thoroughly dry before use.

Technical Specification

Environmental Conditions

Operating Temperature| 10°C – 40°C (50°F – 104°F)
Storage Temperature| -20°C – 60°C (-4°F – 140°F)
Humidity| 0 – 93% RH
Atmospheric Pressure| 70.0 kPa – 106 kPa

Amplifier Compatibility

•1.5mm DIN TouchProof connector, or
•249-style keyhole connector
Input Amplitude Range| 0 – 1 VDC
Input Frequency Range| DC – 2 Hz
Power| Sensor is self-powered.
Host amplifier’s input shall be isolated from mains per IEC 60601-1

Warning and Caution
Caution: Federal (USA) law restricts this device to sale by or on the order of a ohysician.
This device must be connected to an electrically isolated input on a sleep recording system.
If sensor becomes wet, make sure to fully dry before using. Take care to dry the sensor connectors.
Refer to host sleep system manual for EMC environment and further warnings and cautions.
This device is not sterile. It s to be worn over clothes.
Units do not present any biological or radioactive threat and may be disposed of according to local regulations, or returned to Neurotronics for disposal.
Any serious incident involving the device should be reported immediately to [Neurotronics and the relevant Competent Authority.
Device contains a lithium battery. For best results, sensor should be put into use within 2 years of the manufacture date.
This sensor should be disconnected from the sleep system when notin use.
The battery is non-serviceable.
This product is not made with natural rubber latex.

Manufacturer’s Declaration

— Guidance and Manufacturer’s Dedaration —
Electromagnetic Emissions — for BP0 Body Position Sensor

Guidance and Manufacturer’s Declaration — Electromagnetic Emissions

The BP01 Body Position Sensor is intended for use in the electromagnetic environment specified below. The customer or the user of the sensor should assure that it is used in such an environment. Refer to host sleep system manual for further EMC guidance.
Emissions Test| Compliance| Electromagnetic Environment — Guidance
RF Emissions
CISPR 11| Group 1| The BP01 Body Position sensor uses RF energy only for its
internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.
RF Emissions
CISPR 11| Class B| The BP01 Body Position Sensor is suitable for use in all establishments, including
domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.
Harmonic Emissions
IEC 61000-3-2| Not applicable,
battery powered device
Voltage Fluctuations /
Flicker Emissions
IEC 61000-3-3| Not applicable,
battery powered device

— Guidance and Manufacturer’s Dedaration —
Electromagnetic Immunity — for BP01 Body Position Sensor

Guidance and Manufacturer’s Dedaration — Electromagnetic Immunity

The BP01 Body Position Sensor is intended for use in the electromagnetic environment specified below. The customer or the user of the BP01 Body Position Sensor should assure that it is used in such an environment. Refer to host sleep system manual for further EMC guidance.
Immunity Test| IEC 60601 Test Level / Compliance Level| Electromagnetic Environment — Guidance
Electrostatic Discharge (ESD)
IEC 61000-4-2| ±8 kV contact
±15 kV air| Floors should be wood, concrete, or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.
Electrical Fast
Transient/Burst
IEC 61000-4-4| Not applicable, cable is less
than 3 m long.| Device is not mains powered. Refer to host system manual for further guidance.
Surge
IEC 61000-4-5| Not applicable| Device is not mains powered. Refer to host system manual for further guidance.
Voltage Dips, Short
Interruptions, and Voltage
Variations on Power Supply
Input Lines
IEC 61000-4-11| Not applicable| Device is not mains powered. Refer to host system manual for further guidance.
Power Frequency (50/60 Hz)
Magnetic Field
IEC 61000-4-8| 30 A/m| Power frequency magnetic fields should be at levels
characteristic of a typical location in a typical commercial or hospital environment.
Conducted RF
IEC 61000-4-6| 3 V ( 0.15 MHz– 80 MHz)
6 V in ISM and amateur
radio bands between 0.15
MHz and 80 MHz
80 % AM at 1 kHz| Portable and mobile RF communications equipment should be used no closer to any part of the BP01 Body Position Sensor, including cables, than the recommended separation distance of 30 cm.
Interference may occur in the vicinity of equipment marked with the following symbol:
Radiated RF
IEC 61000-4-3| 10 V/m
80 MHz -2.7 GHz
80 % AM at 1 kHz
Complies with table 9 of
IEC 60601-1-2:2014.

EMC Warnings
Portable and mobile RF communications equipment may introduce interference onto sensor signal. I interference is noticed, move device away from source of interference.
Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally.
Device contains no replaceable cables, transducers, or accessories. Use of accessories, transducers and cables other than those specified or provided by the manufacturer of this equipment could resultin increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and resultin improper operation.
BP01 Body Position Sensor is for use in a professional or home healthcare environment. Not for use in an MRI environment. Not for use in the vicinity of HF electrosurgical equipment.
To ensure EM compatibility and safety, inspect sensor cable and enclosure before each use to verify there is no damage. If damage is noticed, discontinue use of sensor and contact Neurotronics support.

Neurotronics, LLC
13800 TECH CITY CIR STE 400
ALACHUA, FL, USA 32615
NIHON KOHDEN EUROPE, GmbH
Raiffeisenstrasse 10
61191 Rosback v.d.H., Germany

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