TM Electronic Stethoscope I
Contents Introduction, Warnings, & Safety DES-I Use Cleaning Warranty Operation Conditions DES-I Modes and LED States doctorgram App Use Electrical Safety 3 11 12 13 13 13 15 15
1.1 Introduction, Warnings, and Safety The doctorgram Stethoscope DES-I (herein referred to as DES-I) is designed to support healthcare professionals in analyzing cardiac and other internal organ sounds. DES-I includes a stethoscope, and a smartphone application. DES-I features sound amplification and audio transmission to a smartphone via Bluetooth that allows the user to open and playback sounds in a mobile application on compatible iOS smartphones and tablets.
1.3 Safety Related Labels & Symbols Consult instructions for use. This product contains electrical and electronic components and must not be disposed of using standard refuse collection. Please consult local directives for disposal of electrical and electronic equipment. This product and packaging does not contain natural rubber latex. This product contains an intentional RF radiator certified by the FCC.
CAUTION: • To reduce the risk of device interference, keep the DES-I at least 1 meter away from all RF emitters including Wifi routers and radios. • To reduce the risks associated with infection follow all cleaning and disinfecting instructions included in this manual. Establish and follow a cleaning and disinfecting schedule. • To reduce the risks associated with inaccurate data acquisition store and operate this stethoscope only as instructed in this manual.
NOTICE: device and/or turn the Bluetooth feature OFF. To reduce the risks associated with environmental this stethoscope. The stethoscope attachment repairable parts inside the DES-I. 1.5 EMC Compliance 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 devicemust accept any interference received, including interference that may cause undesirable operation.
harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures: -- Reorient or relocate the receiving antenna. -- Increase the separation between the equipment and receiver.
1.6 Indications forUse DES-I is intended to be used as a part of a physical assessment of a patient by healthcare professionals for diagnostic decision support in clinical settings. DES-I is intended for use on pediatric and adult patients. Itcan electronically amplify,filter, and transfer sounds to the accompanying mobile application for storage and sharing.
auscultation should be followed including background noise reduction and optimal patient positioning. © 2019 GV Concepts, Inc.
In order to transmit sounds to the doctorgram App, the stethoscope and device must be connected via Bluetooth. DES-I uses a Bluetooth Smart wireless data link. The Bluetooth range will be reduced when objects (walls, furniture, people, etc) are between the DES-I and a paired mobile device. To improve Bluetooth connection, reduce the distance and/or allow a line of sight between the DES-I and mobile device. 1.
1.9 Contents and Operation The package includes (1) stethoscope , (1) headphone, and (1) micro USB cable. For recording functionality, the system requires smart mobile device with Bluetooth Smart capabilities. The compatible hardware and software platforms are listed below. System Requirements The mobile app software can be used on iPhone 5/5C/5S and above, iPad* Mini 2/3 and above, iPad Air and above, iPad Pro, iPad 3rd and above with iOS 9.0 and higher.
2.1 DES-I Use Charge Battery The battery of DES-I will need to be charged; insert the included micro USB cable into the USB port on thedevice and plug the other end into the included USB charger. The LED will begin to yellow, signifying that it is charging. The yellow LED will be off when the device is fully charged. Power On/Off button Press “ON” and Green LED will be flashing around 3 seconds. Please wait till Green LED is solid on before releasing “ON” button.
3.1 Cleaning Cleaning and Disinfecting Procedure The stethoscope should be cleaned between each patient use. All external parts of the hardware can be cleaned with 70% isopropyl alcohol wipes. NOTE: DO NOT immerse the device in any liquid or subject it to any high-pressure/autoclave sterilization processes. © 2019 GV Concepts, Inc.
4.1 Warranty doctorgram provides a limited warranty for doctorgram Electronic Stethoscope I. Please visit doctorgram.com/warranty for a full description of the warranty. 5.1 Operating Conditions Environmental The operating range of the DES-I is -30° to 40°C (-22° to 104°F), and 15% to 93% relative humidity.The storage andtransport range is -40° to 55°C (-40° to 131° F), and 15% to 93% relative humidity. Acceptable pressure is 1 atm.
ON DES-I connects to mobile device via Bluetooth SLOW FLASHING 3 SECONDS OF FLASHING ON ON Low battery level 0.2 second ON and 2 second off Data Overrun 3 second ON and OFF DES-I is not functioning properly ON Battery is being charged OFF Battery is fully charged © 2019 GV Concepts, Inc.
7.1 doctorgram App Use Installation for iPhone Open the iTunes App Store using a supported mobile device. Ensure that the device is connected to the internet and search for the doctorgram App.Followthe instructions to download the doctorgram App and wait until it has finished installing. Installation for iPad Open the iTunes App Store using a supported iPad model. Ensure that the device is connected to the internet.
Warning: The use of accessories other than those specified, with the exception of accessories sold by GV Concepts as replacement parts, may result in increased emissions or decreased immunity of the doctorgram Electronic Stethoscope I. Warning: The doctorgram Electronic Stethoscope I should not be used adjacent to or stacked with other equipment.
Guidance and Manufacturer’s Declaration - Electromagnetic Immunity The doctorgram Electronic Stethoscope I is intended for use in the electromagnetic environment specified below. The user of the doctorgram Electronic Stethoscope I should assure that it is used in such an environment.
Immunity Test Power frequency (50/60 Hz) magnetic field IEC 61000-4-8 IEC 60601 Test Level 3 A/m Compliance Level 3 A/m Electromagnetic Environment-Guidance Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial magnetic field or hospital environment. NOTE UT is the a.c.
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and is affected by absorption and reflection from structures, objects and people. a Field strength from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy.
9.1 Manufacturing & Regulatory Information Manufactured by: GV Concepts, Inc. 3240 S. White Road, #286 San Jose, CA 95148 USA www.doctorgram.com © 2019 GV Concepts, Inc. All Rights Reserved, and doctorgram are trademarks of GV Concepts, Inc. Other company and product names may be trademarks of their respective owners.
