EarlySense InSight AME-01350-US User Manual
  1. Manuals
  2. Brands
  3. EarlySense Manuals
  4. Medical Equipment
  5. InSight AME-01350-US
  6. User manual

EarlySense InSight AME-01350-US User Manual

Hide thumbs
Table of Contents

Advertisement

Quick Links

Advertisement

Table of Contents
loading
Need help?

Need help?

Do you have a question about the InSight AME-01350-US and is the answer not in the manual?

Questions and answers

Related Manuals for EarlySense InSight AME-01350-US

Summary of Contents for EarlySense InSight AME-01350-US

  • Page 2 EarlySense Modular EarlySense InSight Bedside Unit User Guide A L L - I N - O N E • S A F E T Y • V I TA L S 0344...

  • Page 3: Important Notice

    Unauthorized use, disclosure or reproduction is prohibited. EarlySense Ltd. assumes no responsibility for errors that may appear in this user guide. EarlySense Ltd. reserves the right to make changes without notice to this user guide and the products described herein.

  • Page 4: Intended Use

    This manual provides the information necessary to setup the contact free Sensing Unit and basic operation of the EarlySense InSight Device that is placed at the patient’s bedside in a safe and efficient manner. For user interface explanations, please refer to the Remote Control and Display (RCD) Unit manual.

  • Page 5: Table Of Contents

    Table of Contents ..........................4 List of Figures ............................5 Safety ..............................6 Supplying Sensors ..........................12 Introduction ......................... 15 1.1 What Is the EarlySense InSight System? ................... 15 1.2 System Components ........................16 1.2.1 Sensing Units ............................17 1.2.2 Sensing Unit Extension Cable ......................

  • Page 6: List Of Figures

    List of Figures Figure 1: EarlySense InSight Components ........................16 Figure 2: Chair Sensing Unit- a cushion with a sensor incorporated inside ............. 17 Figure 3: InSight Device Indicators and Keys ....................... 18 Figure 4: InSight Device- Side View ..........................19 Figure 5: Positioning the Sensing Unit and the InSight Device ..................

  • Page 7: Safety

    Changes or modifications not expressly approved by EarlySense Ltd. could affect the safety or effectiveness of the EarlySense InSight System and void the system's warranty. • The EarlySense Insight Sensing Units (the under the mattress Sensing Unit, the “chair” Sensing Unit) should be connected and used only with the EarlySense InSight Device. •...
  • Page 8 The EarlySense InSight Device is an internally, continuously powered ordinary non-transit operable portable equipment with type BF applied part. The EarlySense InSight Device is classified as IP20 device, provides protection against access to hazardous parts. The Device is not protected against water, and should be kept dry.
  • Page 9 Electrical Shock The EarlySense InSight Device contains no user serviceable parts. Do not open the Device's covers. The EarlySense InSight Device is not waterproof. Keep the InSight Device dry to avoid electrical shock or malfunction. Contraindications for Use The EarlySense InSight System is contraindicated for use in: •...
  • Page 10 EarlySense InSight System and void the system's warranty. • Do not use the EarlySense InSight System for patients who weigh more than 200 kg (440 Pounds). Usage of the system for such patients might result in malfunction of the Sensing Unit •...
  • Page 11 Portable RF communications equipment, including antennas, such as mobile phones, Walkie-Talkie, mobile radios, etc. should not be used closer than 30 cm (12 inches) to any part of EarlySense System, including its cables, as it can negatively affect its performance WARNING Due to the small size of the system’s label it can be read only from the intended position...
  • Page 12 Indoor operation only Class II equipment (double insulated electrical Device, does not require a safety connection to electrical earth) Non-ionizing Electromagnetic Radiation Solid object protected and splash-proof accessory IP24 Solid object protected IP20 Sorted disposal Manufactured by: Date of manufacture: MR Unsafe- Keep away from magnetic resonance imaging (MRI) equipment Rx Only...

  • Page 13: Supplying Sensors

    For further explanation refer to EarlySense Cradle User Guide. Supplying Sensors The EarlySense Bed Sensing Units are supplied in a separate package. Each Sensing Unit is isolated to ensure safe transport. The EarlySense InSight System may also be provided with optional Chair Sensing Unit/s.
  • Page 14 Original Equipment Manufacturer Portable Document Format Personal Identification Number Post Meridiem (L) – After Noon RCD U Remote Control and Display Device which can be EarlySense Central Display Station (CDS) or other regulatory-approved central monitoring station Turn Interval Respiratory Rate Radio Frequency...
  • Page 15 Blank page for double-sided printing...

  • Page 16: Introduction

    This chapter introduces the EarlySense InSight and its components. 1.1 What Is the EarlySense InSight System? The EarlySense InSight System developed by EarlySense Ltd. is designed for continuous and contact-free measurement of Heart and Respiratory Rate. In addition, the System tracks body motion;...

  • Page 17: System Components

    1.2 System Components The system consists of a Sensing Unit, a Cradle and InSight Device, connected by a cable. 1. InSight Device 2. InSight Cradle 3. Bed Sensing Unit (to be placed under the mattress Figure 1: EarlySense InSight Components...

  • Page 18: Sensing Units

    Only one Sensigs device can be connected to the EarlySense InSight Device, either the Bed Sensing Unit or the Chair Sensing Unit If using an accessory switch (provided by Earlysense), Both Sensing units can be connected to the InSight Device together.

  • Page 19: Insight Device

    Communication with RCD Figure 3: InSight Device Indicators and Keys The EarlySense InSight System has not been studied on any specific patient group, nor has it been studied as a diagnostic tool for any specific disease or medical condition. It is meant as an adjunctive tool only for measuring Respiratory Rate, NOTE Heart Rate and Movement.

  • Page 20: Earlysense Insight Device Controls And Indicators

    1.2.4 EarlySense InSight Device Controls and Indicators The InSight Device contains the following controls and indicators: Operational Buttons- located at the side panel, and can be configured to fulfill various functions LEDs - A. Alert LED- indicates either a technical or a clinical active alert at this InSight Device.

  • Page 21: Insight Device Specifications

    1.3 InSight Device Specifications Physical Characteristics Table 3: Physical Characteristics Characteristic Bed Sensing Unit Chair Sensing Unit InSight Unit Sensor: 300 X 210 X 6.45 Dimensions 300 X 210 X 6.45 mm 145.6 x 62 x 65.07 mm With handles: 420.7 X 210 X 13.8 mm Weight 730 gr...

  • Page 22: Additional Specifications

    InSight Device:15%−90% Non-condensing Relative Humidity Sensing units:10%-90% Non -condensing InSight Device 700−1,060 hPa Atmospheric Pressure Sensing Device 500−1,060 hPa Cables Used with the Sensing Units and EarlySense InSight Device Table 7: Cables Connector Connector Type Type of Cable Length # of Identical...
  • Page 23 Respiratory Rate Heart Rate Movement The system detects HR that is > 1.8 times the RR Total system accuracy, including undetected signals 90% for RR and for HR. The total system accuracy was measured as +/- 10% of the predicate device. Alert Thresholds Default: Default:...
  • Page 24 Blank page for double-sided printing...

  • Page 25: Set Up

    (See Figure 5). Ensure that the Sensing Unit’s cord is secured at the top of the bed, to prevent tripping while patient exits the bed. If the Sensing Unit is placed on a framework which does not allow solid support, please consult your authorized EarlySense Representative. Figure 5: Positioning the Sensing Unit and the InSight Device...

  • Page 26: Positioning The Chair Sensing Unit On A Chair

    The patient should not be in direct contact with the Sensing Unit. A mattress cover should always be placed as a barrier between the Sensing Device of the EarlySense InSight System and the patient. CAUTION Handle the InSight System with care.

  • Page 27: Visual And Audial Alerts

    2.3 Visual and Audial Alerts The following table explains the audial and visual alerts displayed by the InSight Device: LED position LED description Definition Indication that there is one of the following technical problems: • A need to check the Sensing Device Flashes blue (connection, position or location) •...

  • Page 28: After Electrical Power Is Restored

    Ensure that the InSight Device's details are appearing correctly upon the RCD Unit Screen. 2.6 Clinical Alert Alerts are used to notify personnel of situations which may require attention. The EarlySense InSight Device alert’s the user that an Alert is active by flashing a LED light, or/and by making an audible sound.

  • Page 29: Cleaning And Disinfecting The Insight Device

    The Bed and Chair Sensing Units should be replaced on an annual basis to ensure proper functionality of the system. No restriction for sensing Unit storage time exists. Minimal expected service life of the InSight Device is 5 years; however, the service can still be provided after this term.

  • Page 30: Manufacturer Declaration

    60601-1-2 standards. The EarlySense InSight System is intended for use in the electromagnetic environment specified below. The customer or the user of the EarlySense InSight should ensure that it is used in such an environment. Table 9: System Compliance Information – Electromagnetic Emissions The EarlySense InSight System is intended for use in the electromagnetic environment specified below.
  • Page 31 Manufacturer declaration Table 10: System Compliance Information – Enclosure Port Immunity to RF Wireless communications equipment Immunity Compliance Band Test Frequency Maximum Level Level Service Modulation Distance(m) (MHz) power (W) (MHz) (V/m) (V/m) Pulse modulation b) 380 –390 TETRA 400 18 Hz FM c) GMRS 460,...
  • Page 32 Table 11: Electromagnetic Immunity for Non-Life-Supporting Systems The EarlySense InSight System is intended for use in the electromagnetic environment specified below. The customer or the user of the EarlySense system should assure that it is used in such an environment. Compliance...
  • Page 33 Table 12: System Compliance Information – Immunity The EarlySense InSight is intended for use in the electromagnetic environment specified below. The customer or the user of the EarlySense InSight System should assure that it is used in such an environment.
  • Page 34 Manufacturer declaration Table 13: Recommended Separation Distances Between Portable and Mobile RF Communications Equipment and the EarlySense System (Non-Life-Supporting) Separation Distance According to Frequency of Transmitter (M) 150kHz to 800 MHz to 2.5 GHz 150 kHz to 80 80 MHz to 800...

  • Page 35: Fcc Compliance Standard Statement

    Appendix: Appendix: FCC Compliance Standard Statement...
  • Page 36 FCC Compliance Standard Statement The FCC Wants You to Know This equipment 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.
  • Page 37 EarlySense.com 800AWest Cummings Park Suite 6400 Woburn, Massachusetts 01801 Phone: 781.373.3228...

This manual is also suitable for:

Insight ame-01350-us-f

Table of Contents