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Dictum Health IDM100 Instructions For Use Manual

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IDM100 Medical Tablet Instructions for Use
Title: DICTUM HEALTH IDM100 MEDICAL TABLET INSTRUCTIONS FOR USE
Originating Author: E Keate
Modifying Author: R. Massie
Date Created: 9/04/2018
Date Modified: 05/28/2020
DCO#: 00271
Document#: 870-00001-01
Revision: AR
Page 1 of 175

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  • Page 1 IDM100 Medical Tablet Instructions for Use Title: DICTUM HEALTH IDM100 MEDICAL TABLET INSTRUCTIONS FOR USE DCO#: 00271 Document#: 870-00001-01 Originating Author: E Keate Date Created: 9/04/2018 Revision: AR Page 1 of 175 Modifying Author: R. Massie Date Modified: 05/28/2020...

  • Page 2: Table Of Contents

    Session Timeout ............................... 43 4.3.5 About ................................44 Action Bar Settings ............................44 4.4.1 Date and Time ..............................45 Title: DICTUM HEALTH IDM100 MEDICAL TABLET INSTRUCTIONS FOR USE DCO#: 00271 Document#: 870-00001-01 Originating Author: E Keate Date Created: 9/04/2018 Revision: AR Page 2 of 175 Modifying Author: R.
  • Page 3 Manual Temperature Test ..........................78 Temperature Results ............................79 10 NON-INVASIVE BLOOD PRESSURE ....................80 10.1 WARNINGS AND CAUTIONS..........................80 Title: DICTUM HEALTH IDM100 MEDICAL TABLET INSTRUCTIONS FOR USE DCO#: 00271 Document#: 870-00001-01 Originating Author: E Keate Date Created: 9/04/2018...
  • Page 4 Glucose Test Results ............................138 20 MAINTENANCE ........................139 20.1 Inspect the IDM 100 and Peripherals ......................139 20.2 Cleaning ................................. 139 Title: DICTUM HEALTH IDM100 MEDICAL TABLET INSTRUCTIONS FOR USE DCO#: 00271 Document#: 870-00001-01 Originating Author: E Keate Date Created: 9/04/2018 Revision: AR Page 4 of 175 Modifying Author: R.
  • Page 5 22.4 EMC Compliance............................. 159 22.5 Emissions and Immunity Information ......................159 22.6 View the Regulatory Summary on the IDM100 Medical Tablet............... 162 23 TECHNICAL SPECIFICATIONS ....................165 24 CLINICAL REFERENCES ......................168 25 TROUBLESHOOTING ........................ 169 25.1 System Error and Warning Messages......................169 25.2...

  • Page 6: Introduction

    The IDM100 Medical Tablet is a portable vital sign and diagnostic medical device with a 25.7 cm (10.1 in) easy-to-use touchscreen interface. High-definition video, image capture, and audio interfaces allow secure communication and evaluation between physicians and patients.

  • Page 7: Indications For Use

    Indications for Use (Essential Performance) The IDM100 Medical Tablet is for use by clinicians and patients to collect, store, and transmit general patient health information and patient vital signs data between the patient and a health care professional. The IDM100...

  • Page 8: Contraindications

    DO NOT use the IDM100 Medical Tablet for any purpose other than specified in this manual without written consent and approval from Dictum Health.

  • Page 9: General Cautions

    DO NOT immerse the IDM100 Medical Tablet in any fluid, place fluids on top, or attempt to clean the device with any liquid detergents or cleaning agents. This may cause an electrical hazard. If immersion occurs, please return to Dictum Health.
  • Page 10 Carefully route cables to reduce the possibility of patient entanglement or strangulation. The device should be placed on a tabletop, cart or stable surface. DO NOT place the IDM100 Medical Tablet on the patient or the patient’s bedside.

  • Page 11: Symbols And Icons

    Symbols and Icons The symbols and icons shown in the table below may appear on the IDM100 Medical Tablet, its components, the packaging, the shipping container, or in this manual. Documentation Symbols WARNING: Indicates conditions or practices that could lead to illness, injury, or death.
  • Page 12 Warehouse storage temperature limitation Operating conditions humidity limitation Do not use if package is opened or damaged Li-ion Lithium-ion battery Recyclable Title: DICTUM HEALTH IDM100 MEDICAL TABLET INSTRUCTIONS FOR USE DCO#: 00271 Document#: 870-00001-01 Originating Author: E Keate Date Created: 9/04/2018 Revision: AR Page 12 of 175 Modifying Author: R.
  • Page 13 Orange Battery is charging; device is plugged in Battery is not charging; device is not plugged in or battery is at full capacity Title: DICTUM HEALTH IDM100 MEDICAL TABLET INSTRUCTIONS FOR USE DCO#: 00271 Document#: 870-00001-01 Originating Author: E Keate...

  • Page 14: Idm100 Medical Tablet Setup

    When charging is complete, the status light turns off. Connect Accessories Labeled ports on either side of the IDM100 Medical Tablet are provided for connecting the accessories to the device. The ports are described below. Title: DICTUM HEALTH IDM100 MEDICAL TABLET INSTRUCTIONS FOR USE...
  • Page 15 Ports on the Right Side of the IDM100 Medical Tablet Spirometer Non-invasive Blood Pressure (NIBP) Thermometer Pulse Oximeter (SpO2) Ports on the Left Side of the IDM Medical Tablet Headphone Stethoscope USBs Camera Ethernet (LAN) AC Power Title: DICTUM HEALTH IDM100 MEDICAL TABLET INSTRUCTIONS FOR USE...
  • Page 16 Acoustic Stethoscope Chest Piece ECG Cables: ECG3A (3-lead) AHA ECG3I (3-lead) IEC ECG10A (12-lead) AHA ECG10I (12-lead) IEC Title: DICTUM HEALTH IDM100 MEDICAL TABLET INSTRUCTIONS FOR USE DCO#: 00271 Document#: 870-00001-01 Originating Author: E Keate Date Created: 9/04/2018 Revision: AR Page 16 of 175 Modifying Author: R.
  • Page 17 3.8A Li-Ion (6-cell) 7.2 V, rechargeable battery 3 hours to charge, 4.5 hours of operation Kickstand for upright tabletop display (optional accessory) Title: DICTUM HEALTH IDM100 MEDICAL TABLET INSTRUCTIONS FOR USE DCO#: 00271 Document#: 870-00001-01 Originating Author: E Keate Date Created: 9/04/2018...

  • Page 18: Power On And Power Off

    Connect to a Local Area Network (LAN) To connect to a LAN: 1. Connect the Ethernet cable of your LAN into the LAN port on the left side of the IDM100 Medical Tablet, shown below. 2. When the LAN connection is active, the LAN port status lights turn green and flashing amber.

  • Page 19: Connect To A Wi-Fi Network

    To connect to a Wi-Fi network: 1. Tap the Wi-Fi icon in the upper right corner of the screen. The Wi-Fi Status screen appears. Title: DICTUM HEALTH IDM100 MEDICAL TABLET INSTRUCTIONS FOR USE DCO#: 00271 Document#: 870-00001-01 Originating Author: E Keate...

  • Page 20: Connect To A Wi-Fi Network With Broadcasting Ssid

    Connect to Wi-Fi Using WPS. The IDM100 Medical Tablet can be connected to a mobile hotspot, smartphone, or other device that can act as a mobile Wi-Fi router. To configure your hotspot or device for use as a mobile Wi-Fi router, refer to the instructions for your mobile device.

  • Page 21: Connect To A Wi-Fi Network Without Broadcasting Ssid

    The Wi-Fi login screen appears. 2. Enter the network password. 3. Tap Connect. When the IDM100 Medical Tablet is connected, the network status shows “Connected” and the Wi-Fi icon turns green. 3.6.2 Connect to a Wi-Fi Network Without Broadcasting SSID To connect to a Wi-Fi network without broadcasting Service Set Identifier (SSID): 1.

  • Page 22: Connect To Wi-Fi Using Wps

    2. Complete the Add Network screen, which appears. 3. Tap Save. When the IDM100 Medical Tablet is connected, the network status shows “Connected” and the Wi-Fi icon turns green. 3.6.3 Connect to Wi-Fi Using WPS To connect to a Wi-Fi network using Wi-Fi Protected Setup (WPS): 1.

  • Page 23: Register The Idm100 Medical Tablet

    Register the IDM100 Medical Tablet Prior to using your new IDM100 Medical Tablet, you must register it. If the device is not registered, “DEVICE NOT REGISTERED” is displayed upon initial power-on. To register your IDM100 Medical Tablet: 1.
  • Page 24 2. Enter the User ID and Password provided by your administrator. 3. Tap REGISTER. The message “Retrieving Registration Information” is displayed. After the device is registered, the message “Device Successfully Registered” is displayed. Title: DICTUM HEALTH IDM100 MEDICAL TABLET INSTRUCTIONS FOR USE DCO#: 00271 Document#: 870-00001-01...

  • Page 25: Login

    Verify that appears, indicating that the Dictum Health server is connected. If appears, indicating that the Dictum Health server is not connected, first ensure that the IDM100 Medical Tablet is connected to the network. If connectivity issues persist, email us: service@dictumhealth.com Login After the device is registered, it is ready for use.

  • Page 26: Home Screen

    3. Tap LOGIN. The Home Screen appears. Home Screen The Home screen provides the main menu options for working with patients, setting up the IDM100 Medical Tablet, viewing the IFU, and taking a patient’s vital signs. At any time, you can return directly to the Home screen by tapping the Home Screen icon in the upper left corner of the screen.

  • Page 27: Touchscreen

    View the Instructions for Use (IFU). 3.10 Touchscreen The IDM100 Medical Tablet is designed with a touchscreen that you use just like a consumer tablet or smartphone. Use your fingertips to touch features on the screen interface as described in the table below.

  • Page 28: Set Up The Bar 228 For Spirometry

    5. To complete setting up the BAR 228, follow the instructions in 4.2.4 Spirometry Settings. *Refer to the BAR 228 video and manual for additional instructions: https://youtu.be/X7iT1OAkyu8 http://www.oregonscientificstore.com/manual/EM221_BAR 228.pdf Title: DICTUM HEALTH IDM100 MEDICAL TABLET INSTRUCTIONS FOR USE DCO#: 00271 Document#: 870-00001-01 Originating Author: E Keate Date Created: 9/04/2018...

  • Page 29: Device Settings

    Device Settings Before using the IDM100 Medical Tablet for the first time, configure the device settings. To view and change device settings: 1. Tap Settings on the Home screen. The Settings menu appears. 2. Follow the instructions provided to view and change the device settings: •...

  • Page 30: Medical Device Settings

    2. Tap Video Conferencing Server to view its settings. 3. Tap Mobile Sync Server to view its settings. Medical Device Settings This section describes how to view and change the settings for the medical devices and IDM100 Medical Tablet accessories: •...

  • Page 31: Ecg Settings

    Interference Filter: Select None, 50 Hz, or 60 Hz. AC interference superimposes even-peaked, regular voltage on the waveforms. This can be caused by a number of external conditions. Title: DICTUM HEALTH IDM100 MEDICAL TABLET INSTRUCTIONS FOR USE DCO#: 00271 Document#: 870-00001-01...

  • Page 32: Temperature Settings

    Ensure that the IDM100 Medical Tablet is not on or near the patient. Ensure proper patient connection of the electrodes. If interference persists, unplug the IDM100 Medical Tablet from AC power and run it on the battery. If this solves the interference, you will know that the noise was introduced through the power line.
  • Page 33 If you are using the Fora IR20b for the first time: • Power on the Fora IR20b, turn on Bluetooth and Tap Find Thermometer. The Find Thermometer screen appears. Title: DICTUM HEALTH IDM100 MEDICAL TABLET INSTRUCTIONS FOR USE DCO#: 00271 Document#: 870-00001-01 Originating Author: E Keate...

  • Page 34: Glucose Meter

    Select Manual Data Entry. 4.2.3 Glucose Meter 1. Tap Glucose Meter. The selection expands to show the Glucose Meter settings. Title: DICTUM HEALTH IDM100 MEDICAL TABLET INSTRUCTIONS FOR USE DCO#: 00271 Document#: 870-00001-01 Originating Author: E Keate Date Created: 9/04/2018...
  • Page 35 IDM100 Medical Tablet Settings screen. When the glucose meter is detected by the table, the meter information appears in the Bluetooth LE Glucose Meters list. Title: DICTUM HEALTH IDM100 MEDICAL TABLET INSTRUCTIONS FOR USE DCO#: 00271 Document#: 870-00001-01...

  • Page 36: Spirometry Settings

    To remove a saved Glucose Meter from the Saved Devices list, tap FORGET on the Glucose Meter Settings screen. 4.2.4 Spirometry Settings 1. Tap Spirometer. The selection expands to display the Spirometer settings. Title: DICTUM HEALTH IDM100 MEDICAL TABLET INSTRUCTIONS FOR USE DCO#: 00271 Document#: 870-00001-01 Originating Author: E Keate Date Created: 9/04/2018...
  • Page 37 • Tap OK to select the BAR 228. After the IDM100 Medical Tablet uses the BAR 228 for the first time, the weather sensor information is saved in the Bluetooth devices list. To see the saved Bluetooth devices, tap the Bluetooth Status icon.

  • Page 38: Blood Pressure Settings

    • Tap SAVE. 4.2.5 Blood Pressure Settings 1. Tap Blood Pressure. The selection expands to display the Blood Pressure settings. Title: DICTUM HEALTH IDM100 MEDICAL TABLET INSTRUCTIONS FOR USE DCO#: 00271 Document#: 870-00001-01 Originating Author: E Keate Date Created: 9/04/2018...

  • Page 39: Scale Settings

    1. Tap Scale. The selection expands to display the Scale settings. 2. Select whether to use the Bluetooth scale: A. To enter weight manually from a scale not connected to the IDM100 Medical Tablet, select Off. B. To use Bluetooth scale, select On.

  • Page 40: Stethoscope Settings

    4. The stethoscope name and address appear in the Bluetooth Stethoscopes list. 5. Tap the stethoscope name to select it, and then tap OK. 6. Enter the PIN number that appears on the stethoscope screen onto the IDM100 Medical Tablet Stethoscope pin entry screen.

  • Page 41: General Settings

    9. Tap OK to continue. To check for a paired stethoscope, tap the Bluetooth icon on the toolbar on the IDM100 Medical Tablet screen. A list of paired devices appears. If the stethoscope is paired, the model number, serial number, and address of the stethoscope are displayed.

  • Page 42: Unit Of Measure

    4.3.1 Unit of Measure 1. Select Unit of Measure. The Unit of Measure options appear. 2. Select either English or Metric. Title: DICTUM HEALTH IDM100 MEDICAL TABLET INSTRUCTIONS FOR USE DCO#: 00271 Document#: 870-00001-01 Originating Author: E Keate Date Created: 9/04/2018...

  • Page 43: Camera

    Session Timeout When the login session is inactive for a selected period of time, the screen turns off. 1. Tap Session Timeout. The Timeout options appear. Title: DICTUM HEALTH IDM100 MEDICAL TABLET INSTRUCTIONS FOR USE DCO#: 00271 Document#: 870-00001-01 Originating Author: E Keate...

  • Page 44: About

    Bottom action bar Bluetooth Wi-Fi Dictum Health Server Top action bar Battery Status Cast Screen Title: DICTUM HEALTH IDM100 MEDICAL TABLET INSTRUCTIONS FOR USE DCO#: 00271 Document#: 870-00001-01 Originating Author: E Keate Date Created: 9/04/2018 Revision: AR Page 44 of 175 Modifying Author: R.

  • Page 45: Date And Time

    • Tap Select time zone. • Select the time zone in which the IDM100 Medical Tablet is located. The time is updated automatically. • Tap the back arrow icon in the bottom action bar to return to the previous menu.
  • Page 46 Select the current time. • Tap Done. • Tap Select time zone. The Select time zone screen appears. Title: DICTUM HEALTH IDM100 MEDICAL TABLET INSTRUCTIONS FOR USE DCO#: 00271 Document#: 870-00001-01 Originating Author: E Keate Date Created: 9/04/2018 Revision: AR Page 46 of 175 Modifying Author: R.

  • Page 47: Bluetooth

    • Select the time zone in which the IDM100 Medical Tablet is located. The time is updated automatically. • Tap the back arrow icon in the bottom action bar to return to the previous menu. • Select whether to use 24-hour format: To use 24-hour format, tap to select it.

  • Page 48: Wi-Fi

    Connect to a Wi-Fi Network. 4.4.4 Dictum Health Server Tap the Dictum Health Server (“DH”) icon. The Status screen appears. Title: DICTUM HEALTH IDM100 MEDICAL TABLET INSTRUCTIONS FOR USE DCO#: 00271 Document#: 870-00001-01 Originating Author: E Keate Date Created: 9/04/2018...

  • Page 49: Battery

    Cast Screen Tap the Cast Screen icon. The Cast Screen Settings screen appears. Tap Settings, and follow the instructions for setting up Miracast. Title: DICTUM HEALTH IDM100 MEDICAL TABLET INSTRUCTIONS FOR USE DCO#: 00271 Document#: 870-00001-01 Originating Author: E Keate...

  • Page 50: Patient Records

    Patient Records A Patient Record is the IDM100 Medical Tablet’s record of an individual’s personal and health data, which the clinician views and updates when conferring with or examining a patient. The IDM100 Medical Tablet provides options to perform the following actions: •...

  • Page 51: Download A Patient Record

    Patient List screen. The Patient Download Search field appears. 2. Enter either the patient’s medical record number (MR#) or the patient’s last name and date of birth. Title: DICTUM HEALTH IDM100 MEDICAL TABLET INSTRUCTIONS FOR USE DCO#: 00271 Document#: 870-00001-01...

  • Page 52: Create A New Patient Record

    3. Tap SAVE. Add a Problem to a Patient Record 1. To add a problem to a patient record, select the PROBLEMS tab in the Patient record. Title: DICTUM HEALTH IDM100 MEDICAL TABLET INSTRUCTIONS FOR USE DCO#: 00271 Document#: 870-00001-01...
  • Page 53 3. Select the correct category on the left. A menu of problems appears on the right. 4. Select the correct problem. 5. Tap ADD. The selected problem is saved to the patient record. Title: DICTUM HEALTH IDM100 MEDICAL TABLET INSTRUCTIONS FOR USE DCO#: 00271 Document#: 870-00001-01...

  • Page 54: Add An Allergy To A Patient Record

    1. To add an allergy to a patient record, tap the ALLERGIES tab in the Patient record. 2. Tap ADD NEW ALLERGY. The Add New Allergy screen appears. 3. Select the appropriate allergy information from each drop-down menu. Title: DICTUM HEALTH IDM100 MEDICAL TABLET INSTRUCTIONS FOR USE DCO#: 00271 Document#: 870-00001-01...

  • Page 55: Add A Medication To A Patient Record

    1. To add a medication to a patient record, tap the MEDICATIONS tab in the Patient record. 2. Tap ADD NEW MEDICATION. The Add New Medication screen appears. Title: DICTUM HEALTH IDM100 MEDICAL TABLET INSTRUCTIONS FOR USE DCO#: 00271 Document#: 870-00001-01...
  • Page 56 To delete a medication, tap the Delete icon for that medication. 7. To add another medication, tap Add New Medication and repeat the previous steps. 8. Tap SAVE. Title: DICTUM HEALTH IDM100 MEDICAL TABLET INSTRUCTIONS FOR USE DCO#: 00271 Document#: 870-00001-01...

  • Page 57: Work With The Current Patient

    2. Locate and select the patient record. The selected patient record is the Current Patient, and an icon representing the patient appears in the lower left corner of the screen. The Current Patient icon displays the patient’s ID photo, name, and ID number. Title: DICTUM HEALTH IDM100 MEDICAL TABLET INSTRUCTIONS FOR USE DCO#: 00271 Document#: 870-00001-01...

  • Page 58: Edit A Patient Record

    1. To edit a patient record, ensure that the correct patient is the Current Patient. 2. Tap the Current Patient icon. A pop-up menu appears. 3. Tap Open Record. The Patient Record screen appears. Title: DICTUM HEALTH IDM100 MEDICAL TABLET INSTRUCTIONS FOR USE DCO#: 00271 Document#: 870-00001-01...

  • Page 59: Notes

    3. Enter notes in the Add a Note field. 4. Tap SAVE. The note is added to the list of notes on the patient record. When notes are added to patient records: Title: DICTUM HEALTH IDM100 MEDICAL TABLET INSTRUCTIONS FOR USE DCO#: 00271 Document#: 870-00001-01...

  • Page 60: Feedings

    The new note notification is added to each patient listed in the Patient List screen, as shown below. The notification badge disappears after you view the notes. 5.11 Feedings 1. Tap the Edit icon next to Feedings. Title: DICTUM HEALTH IDM100 MEDICAL TABLET INSTRUCTIONS FOR USE DCO#: 00271 Document#: 870-00001-01 Originating Author: E Keate...

  • Page 61: Conduct A Test On A Patient

    1. To conduct a test, ensure that the patient to be tested is the Current Patient. 2. Open the Tests menu. There are different ways to open the Tests menu: Title: DICTUM HEALTH IDM100 MEDICAL TABLET INSTRUCTIONS FOR USE DCO#: 00271...
  • Page 62 In any configuration, if the Vitals test is selected to be available on the IDM100 Medical Tablet, the Vitals icon always appears at the beginning of the list. Also note that the tests appear in the same order.
  • Page 63 3. Select the desired test. If necessary, scroll the list up or down to bring more items into view. Available tests are as follows. Your IDM100 Medical Tablet may not provide all of these tests. • Vitals • Weight & Height •...

  • Page 64: Virtual Exam

    Virtual Exam The Virtual Exam provides real time video-conferencing between the IDM100 Medical Tablet user (HCP or patient) and a remotely located HCP. This feature is available during all test modalities, except audiometry. The Virtual Exam is subject to the limitations imposed by the Indications for Use, where an HCP must be physically present with the subject for both audiometry and spirometry.
  • Page 65 Tap YES to accept an incoming Virtual Exam call. Your Virtual Exam is now in progress. The patient appears on the left and the remote health care professional appears on the right. Title: DICTUM HEALTH IDM100 MEDICAL TABLET INSTRUCTIONS FOR USE DCO#: 00271 Document#: 870-00001-01...

  • Page 66: Virtual Exam Controls

    Tap the Camera icon to take a still photo of the patient. The photo is sent to the remote clinician automatically. The photo can be saved. Tap the Video icon on the patient’s side to turn off the IDM100 Medical Tablet’s video. Tap the Video icon on the clinician’s screen to turn off the remote clinician’s video.

  • Page 67: Virtual Exam Status Messages

    When in Audio Only mode, videos are paused and the screens appear as shown below. Audio is still active. In Privacy mode, the screen looks like this: Virtual Exam Status Messages Title: DICTUM HEALTH IDM100 MEDICAL TABLET INSTRUCTIONS FOR USE DCO#: 00271 Document#: 870-00001-01...

  • Page 68: Guidelines For Using The Stethoscope During A Virtual Exam

    • Audio feedback may occur, if during a virtual exam, the patient’s IDM100 Medical Tablet and the clinician’s laptop are too close; for instance, during a demonstration in which both devices are in the same room. Moving them away from each other, or muting their microphones, will resolve the feedback.
  • Page 69 Virtual Exam videoconference audio is temporarily-suspended during stethoscope use. When STOP is selected to conclude a stethoscope recording, Virtual Exam videoconference audio will resume. Be prepared to adjust output volume of headphones, if needed. Title: DICTUM HEALTH IDM100 MEDICAL TABLET INSTRUCTIONS FOR USE DCO#: 00271 Document#: 870-00001-01...

  • Page 70: Introduction To Testing

    Use the Search field above the Table of Contents to search for a term or topic. • Tap a topic name to open that topic in a reading screen. Title: DICTUM HEALTH IDM100 MEDICAL TABLET INSTRUCTIONS FOR USE DCO#: 00271 Document#: 870-00001-01...

  • Page 71: Test-Specific Instructions And Cautions

    To close the window, tap the circled “X”. 3. To view test-specific cautions, tap the Cautions icon in the bottom action bar. The Cautions appear in a separate window. Title: DICTUM HEALTH IDM100 MEDICAL TABLET INSTRUCTIONS FOR USE DCO#: 00271 Document#: 870-00001-01...

  • Page 72: Test Results And Summary

    Tap on a set of results in the summary to display more details. • To conduct other tests, tap the appropriate test icons. Title: DICTUM HEALTH IDM100 MEDICAL TABLET INSTRUCTIONS FOR USE DCO#: 00271 Document#: 870-00001-01 Originating Author: E Keate...

  • Page 73: Weight & Height

    2. Select the mode: Infant for children younger than 2 years of age, or, Pedi/Adult for all other patients. • Infant mode provides greater precision. Title: DICTUM HEALTH IDM100 MEDICAL TABLET INSTRUCTIONS FOR USE DCO#: 00271 Document#: 870-00001-01 Originating Author: E Keate...
  • Page 74 For information on BMI, see section 24 Clinical References. 5. Tap SAVE. The test results are saved to the patient record, and the TESTS summary screen for the patient appears. Title: DICTUM HEALTH IDM100 MEDICAL TABLET INSTRUCTIONS FOR USE DCO#: 00271 Document#: 870-00001-01...

  • Page 75: Temperature

    Fluid ingress may interfere with unit functionality. Cleaning guidelines should be followed as outlined in this document to prevent fluid entering unit. Genius 2 Temperature Test Title: DICTUM HEALTH IDM100 MEDICAL TABLET INSTRUCTIONS FOR USE DCO#: 00271 Document#: 870-00001-01 Originating Author: E Keate...
  • Page 76 8. Gently place the probe in the patient’s ear canal and seal the opening with the probe tip. 9. Ensure that the probe shaft is aligned with the ear canal for consistent results. Title: DICTUM HEALTH IDM100 MEDICAL TABLET INSTRUCTIONS FOR USE DCO#: 00271...

  • Page 77: Genius 2 Thermometer

    2 seconds and then enters sleep mode. 5. Return the thermometer to its base for storage. Fora IR20b Temperature Test 1. Tap the Temperature test icon. Title: DICTUM HEALTH IDM100 MEDICAL TABLET INSTRUCTIONS FOR USE DCO#: 00271 Document#: 870-00001-01 Originating Author: E Keate...

  • Page 78: Manual Temperature Test

    For manual ear temperature, first turn on Manual Entry (for more information, see section 4.2.2 Temperature Settings). The entry dial for the selected mode appears. Title: DICTUM HEALTH IDM100 MEDICAL TABLET INSTRUCTIONS FOR USE DCO#: 00271 Document#: 870-00001-01 Originating Author: E Keate...

  • Page 79: Temperature Results

    2. To save the results, tap SAVE. The test results are saved to patient record, and the TESTS summary screen for the patient appears. Title: DICTUM HEALTH IDM100 MEDICAL TABLET INSTRUCTIONS FOR USE DCO#: 00271 Document#: 870-00001-01...

  • Page 80: Non-Invasive Blood Pressure

    American National Standard, Electronic or automated sphygmomanometers. The IDM100 Medical Tablet measures the systolic blood pressure (mmHg), diastolic blood pressure (mmHg), pulse (bpm), MAP (mean arterial pressure – a calculated reading that yields an approximate value in mmHg), as well as max cuff pressure (maximum pressure during measurement).

  • Page 81: Best Practices

    Blood pressure readings may also be affected by the position of the subject, his/her physiologic condition, and other factors. All air hoses and cuffs used to connect the patient to the module must be approved by Dictum Health. Hoses of a certain material and/or durometer may cause the module to perform improperly. Also, cuffs that are extremely small, or large, in size for the patient may cause errors depending on the BP mode selection.

  • Page 82: Nibp Test

    1. Tap the NIBP test icon. The NIBP setup screen appears. 2. Select the Mode, Inflate Pressure, and Cuff position (Sitting or Supine). Title: DICTUM HEALTH IDM100 MEDICAL TABLET INSTRUCTIONS FOR USE DCO#: 00271 Document#: 870-00001-01 Originating Author: E Keate...
  • Page 83 If necessary, select the Mode, Inflate Pressure, or Cuff Position. Selections are highlighted in orange. NIBP Configurations are shown below. Adult NIBP Pediatric NIBP Title: DICTUM HEALTH IDM100 MEDICAL TABLET INSTRUCTIONS FOR USE DCO#: 00271 Document#: 870-00001-01 Originating Author: E Keate Date Created: 9/04/2018...
  • Page 84 9. Ensure that the air hose is not compressed, crimped or damaged. 10. Tap START. The test begins. After the test has completed, the test results appear. Title: DICTUM HEALTH IDM100 MEDICAL TABLET INSTRUCTIONS FOR USE DCO#: 00271 Document#: 870-00001-01...
  • Page 85 11. Tap SAVE. The test results are saved to the patient record, and the TESTS summary screen for the patient appears. Hypertension interpretative values are only for patients 13 years of age and older. Title: DICTUM HEALTH IDM100 MEDICAL TABLET INSTRUCTIONS FOR USE DCO#: 00271 Document#: 870-00001-01...

  • Page 86: Pulse Oximeter

    DS100A’s Instructions for Use for proper sensor application. Do not power on the IDM100 Medical Tablet with the NellCor DS100A connected. This may result in an error message. Disconnect and then reconnect the cable/sensor pair to resolve. If the issue persists, try a new cable/sensor pair.
  • Page 87 3. 3. If any of the situations described in this step occurs, reposition the sensor or choose an alternate sensor for use on a different site. Title: DICTUM HEALTH IDM100 MEDICAL TABLET INSTRUCTIONS FOR USE DCO#: 00271 Document#: 870-00001-01...
  • Page 88 If Respiratory Rate (RR) is not acquired, the test will not complete; tap the back arrow icon to return to the previous screen and re-attempt the test. Title: DICTUM HEALTH IDM100 MEDICAL TABLET INSTRUCTIONS FOR USE DCO#: 00271 Document#: 870-00001-01...
  • Page 89 Manual Mode: 5. Tap SAVE. The test results are saved to the patient record, and the TESTS summary screen for the patient appears. Title: DICTUM HEALTH IDM100 MEDICAL TABLET INSTRUCTIONS FOR USE DCO#: 00271 Document#: 870-00001-01 Originating Author: E Keate...

  • Page 90: Respiratory Rate

    5. Select the number of breaths per minute counted by scrolling the dial up or down. Stop when the correct number is highlighted by the blue strip. Title: DICTUM HEALTH IDM100 MEDICAL TABLET INSTRUCTIONS FOR USE DCO#: 00271 Document#: 870-00001-01...
  • Page 91 6. Tap SAVE. The test results are saved to the patient record, and the TESTS summary screen for the patient appears. Title: DICTUM HEALTH IDM100 MEDICAL TABLET INSTRUCTIONS FOR USE DCO#: 00271 Document#: 870-00001-01 Originating Author: E Keate Date Created: 9/04/2018...

  • Page 92: Vitals

    • Place the SpO2 sensor on the patient. 4. Conduct testing of: Title: DICTUM HEALTH IDM100 MEDICAL TABLET INSTRUCTIONS FOR USE DCO#: 00271 Document#: 870-00001-01 Originating Author: E Keate...
  • Page 93 Select the patient’s pain level using the Pain entry dial (0-10). 7. When all testing has been completed, review the results and patient data. 8. Select SAVE. Title: DICTUM HEALTH IDM100 MEDICAL TABLET INSTRUCTIONS FOR USE DCO#: 00271 Document#: 870-00001-01...

  • Page 94: Spirometry

    BAR 228 is active. • The BAR 228 must be in the same immediate vicinity as the IDM100 Medical Tablet. • If the BAR 228 is unavailable, enter BTPS per the following requirement. Enter the barometric pressure as given by a barometer in the immediate vicinity.

  • Page 95: Gli Predictive Norms

    Keep tongue away from the flow sensor transducer to avoid blocking it. • Keep chin up, so as not to restrict the airway. 14.2 GLI Predictive Norms Title: DICTUM HEALTH IDM100 MEDICAL TABLET INSTRUCTIONS FOR USE DCO#: 00271 Document#: 870-00001-01 Originating Author: E Keate...

  • Page 96: Btps Entry

    The required Oregon Scientific BAR 228 is a Bluetooth Low Energy (BTLE) device that measures atmospheric conditions and transmits that data to the IDM100 Medical Tablet for BTPS correction. The BAR 228 eliminates the need for manual measurement and entry of atmospheric conditions data for BTPS correction. Perform manual measurement and entry of BTPS only if the BAR 228 is unavailable.

  • Page 97: Spirometer Test

    Determine BTPS per the following requirements: Check the Barometric Pressure, Temperature, and Humidity of the IDM100 Medical Tablet’s location and enter these values into the BTPS fields. Enter barometric pressure as given by a barometer in the immediate vicinity. Do not enter the normalized sea-level pressure as commonly listed on internet sites on meteorological data resources.
  • Page 98 2. Align tab of handle with notch on sensor. 3. Ensure that handle edges sit inside the rails on the sensor, when sensor is pushed into handle. Title: DICTUM HEALTH IDM100 MEDICAL TABLET INSTRUCTIONS FOR USE DCO#: 00271 Document#: 870-00001-01...
  • Page 99 Ensure that the patient is wearing the Softclip nose clip. • Hold the handle completely still and tap NEXT to begin the Spirometry test. Title: DICTUM HEALTH IDM100 MEDICAL TABLET INSTRUCTIONS FOR USE DCO#: 00271 Document#: 870-00001-01 Originating Author: E Keate...
  • Page 100 A graph of the exhalation flow rate data appears as the patient exhales. To halt the test for any reason before it has concluded, tap STOP. The test stops automatically when it has concluded. Title: DICTUM HEALTH IDM100 MEDICAL TABLET INSTRUCTIONS FOR USE DCO#: 00271 Document#: 870-00001-01...
  • Page 101 To go to the Best Effort screen, tap DONE. Proceed to step 14. 8. To begin Test 2, tap START 2. 9. Complete Test 2. Perform the same steps described previously and follow the on-screen instructions. Title: DICTUM HEALTH IDM100 MEDICAL TABLET INSTRUCTIONS FOR USE DCO#: 00271 Document#: 870-00001-01...

  • Page 102: Spirometer Maintenance

    Maintenance After every patient, or at least once daily Disinfect handle by wiping (20.2 Cleaning) Annually Replace Spiragrip. Title: DICTUM HEALTH IDM100 MEDICAL TABLET INSTRUCTIONS FOR USE DCO#: 00271 Document#: 870-00001-01 Originating Author: E Keate Date Created: 9/04/2018 Revision: AR Page 102 of 175 Modifying Author: R.

  • Page 103: Electrocardiograph

    It is recommended to check the ECG cable and electrodes and tablet for damage prior to use. If damage exists, do not use the ECG cable, and contact your local Dictum Health Sales Office or your authorized Dictum Health dealer or distributor to have it replaced.

  • Page 104: Ecg Status Messages

    Failure to do so can result in AC power line frequency and interference on the ECG trace. If using a PTZ camera installed on the IDM100 Medical Tablet USB camera port, you must use supplied power supply. Failure to do so can result in AC power line frequency and interference on the ECG trace.

  • Page 105: 12-Lead Ecg Test

    Electrode Position Arms Below the shoulders. Legs Below the inguinal fold anteriorly. Below the gluteal fold posteriorly. Title: DICTUM HEALTH IDM100 MEDICAL TABLET INSTRUCTIONS FOR USE DCO#: 00271 Document#: 870-00001-01 Originating Author: E Keate Date Created: 9/04/2018 Revision: AR Page 105 of 175 Modifying Author: R.
  • Page 106 3. Ensure that each electrode is connected correctly on the patient. After each electrode is successfully attached, the electrode status turns green on the Electrode Placement screen. A red electrode status indicates that the corresponding electrode is disconnected. Title: DICTUM HEALTH IDM100 MEDICAL TABLET INSTRUCTIONS FOR USE DCO#: 00271 Document#: 870-00001-01...
  • Page 107 Dashes, or flat lines, instead of waveforms, indicate that the signal is out of range and that corrective action may be required if the issue does not resolve. 6. Record the ECG. Title: DICTUM HEALTH IDM100 MEDICAL TABLET INSTRUCTIONS FOR USE DCO#: 00271 Document#: 870-00001-01...

  • Page 108: 12-Lead Ecg Test Results

    After the ECG recording concludes, the ECG test results screen appears. If interpretation in ECG Settings (4.2.1 ECG Settings) is disabled, only the graphed results appear, as shown in the example below. Title: DICTUM HEALTH IDM100 MEDICAL TABLET INSTRUCTIONS FOR USE DCO#: 00271 Document#: 870-00001-01 Originating Author: E Keate...
  • Page 109 If interpretation in ECG Settings is enabled, graphed results with measurement appear, as shown in the example below. ECG calculated measurements return in addition when interpretation is enabled. For more information, refer to Dictum Health’s “IDM100 Diagnostic ECG Measurements for Clinicians”. Caution: If dashes, instead of numeric data, are returned, please note that the ECG Calculated Measurements could be affected due to patient, or system, related issues.
  • Page 110   Below are examples of the report types (default, 4 3, 2 6, and 1 12 ). Title: DICTUM HEALTH IDM100 MEDICAL TABLET INSTRUCTIONS FOR USE DCO#: 00271 Document#: 870-00001-01 Originating Author: E Keate Date Created: 9/04/2018 Revision: AR Page 110 of 175 Modifying Author: R.
  • Page 111 D. Use the calipers to confirm data of a user-selected area on the report: The Calipers switch appears for all views, except Report. • If Calipers is turned off, then turn Calipers on. Title: DICTUM HEALTH IDM100 MEDICAL TABLET INSTRUCTIONS FOR USE DCO#: 00271 Document#: 870-00001-01 Originating Author: E Keate...
  • Page 112 3. Enter ECG comments and assessment. • Clinician: 1) Tap the top comments box under Interpretation. 2) Enter comments, and tap SAVE. Title: DICTUM HEALTH IDM100 MEDICAL TABLET INSTRUCTIONS FOR USE DCO#: 00271 Document#: 870-00001-01 Originating Author: E Keate Date Created: 9/04/2018...
  • Page 113 4) Enter comments (optional) in the Add Comment box: • Tap the Add your initials box to enter your Initials. • Tap CONFIRM. Title: DICTUM HEALTH IDM100 MEDICAL TABLET INSTRUCTIONS FOR USE DCO#: 00271 Document#: 870-00001-01 Originating Author: E Keate Date Created: 9/04/2018...

  • Page 114: 3-Lead Ecg Test

    • Ensure that the patient is in a reclining position with head slightly higher than the heart and legs. Title: DICTUM HEALTH IDM100 MEDICAL TABLET INSTRUCTIONS FOR USE DCO#: 00271 Document#: 870-00001-01 Originating Author: E Keate...
  • Page 115 Body Part Electrode Position Arms Below the shoulders. • Connect the electrodes as specified on the Electrode Placement screen. Title: DICTUM HEALTH IDM100 MEDICAL TABLET INSTRUCTIONS FOR USE DCO#: 00271 Document#: 870-00001-01 Originating Author: E Keate Date Created: 9/04/2018 Revision: AR Page 115 of 175 Modifying Author: R.
  • Page 116 If you are familiar with the ECG Preview screen functions, go to step 6. 5. Use ECG Preview to prepare to record ECG. When the ECG initiates, the data is plotted in real time. Title: DICTUM HEALTH IDM100 MEDICAL TABLET INSTRUCTIONS FOR USE DCO#: 00271 Document#: 870-00001-01...
  • Page 117 6. Record the ECG. Wait until the ECG signals stabilize on the Preview screen. Title: DICTUM HEALTH IDM100 MEDICAL TABLET INSTRUCTIONS FOR USE DCO#: 00271 Document#: 870-00001-01 Originating Author: E Keate...

  • Page 118: 3-Lead Ecg Test Results

    If interpretation in ECG Settings is enabled, graphed results with measurement appear, as shown in the example below. ECG calculated measurements return in addition when interpretation is enabled. For more information, refer to Dictum Health’s “IDM100 Diagnostic ECG Measurements for Clinicians”. Title: DICTUM HEALTH IDM100 MEDICAL TABLET INSTRUCTIONS FOR USE...
  • Page 119 Review the ECG results to ensure that the data is valid and ready for assessment. 1. Review the ECG results to ensure that the data is valid and ready for interpretation. Title: DICTUM HEALTH IDM100 MEDICAL TABLET INSTRUCTIONS FOR USE DCO#: 00271...
  • Page 120 Below are examples of the report types (default, 4 3, 2 6, and 1 12 ). Report (Default)  Title: DICTUM HEALTH IDM100 MEDICAL TABLET INSTRUCTIONS FOR USE DCO#: 00271 Document#: 870-00001-01 Originating Author: E Keate Date Created: 9/04/2018 Revision: AR Page 120 of 175 Modifying Author: R.
  • Page 121 The confirming physician manually selects the Arrhythmia type from a drop-down menu (described below). 3. Enter ECG comments and assessment. Title: DICTUM HEALTH IDM100 MEDICAL TABLET INSTRUCTIONS FOR USE DCO#: 00271 Document#: 870-00001-01...
  • Page 122 Atrial Fibrillation / Flutter CVR Unclassified Rhythm Atrial Fibrillation / Flutter RVR 3) Scroll the list to locate and select the Arrhythmia type from the drop-down menu. Title: DICTUM HEALTH IDM100 MEDICAL TABLET INSTRUCTIONS FOR USE DCO#: 00271 Document#: 870-00001-01 Originating Author: E Keate...
  • Page 123 Below is an example of the 3-Lead ECG Results Summary screen without measurements. Below is an example of the 3-Lead ECG Results Summary screen with measurements. Tap the icon to return to the Save Results screen. Title: DICTUM HEALTH IDM100 MEDICAL TABLET INSTRUCTIONS FOR USE DCO#: 00271 Document#: 870-00001-01...

  • Page 124: Stethoscope

    Stethoscope Listen to heart and lung function of a patient with the IDM100 Medical Tablet. During stethoscope use, Virtual Exam conference audio is temporarily suspended. Warning Disconnect the headphones from the IDM100 Medical Tablet prior to defibrillation. The stethoscope headphones are not considered a defibrillation-proof applied part and may cause injury if connected during defibrillation.
  • Page 125 8. When the Stethoscope audio is ready for capture, tap RECORD to begin. Stethoscope audio records for up to 20 seconds. To stop the test before 20 seconds, tap STOP. Title: DICTUM HEALTH IDM100 MEDICAL TABLET INSTRUCTIONS FOR USE DCO#: 00271...
  • Page 126 10. To enter comments about the stethoscope results, tap Comments. 11. Tap SAVE. The test results are saved to the patient record, and the TESTS summary screen for the patient appears. Title: DICTUM HEALTH IDM100 MEDICAL TABLET INSTRUCTIONS FOR USE DCO#: 00271 Document#: 870-00001-01...

  • Page 127: Cameras

    Cameras Use the integrated front and rear cameras of the IDM100 Medical Tablet to take images • Photo document as part of an in person or virtual exam visit with a patient • Patient or provider headshot To capture images: 1.
  • Page 128 2. Compose photo, using the IDM100 Medical Tablet’s screen to confirm the image. 3. Tap the Capture Photo icon. Warning: The IDM100 Medical Tablet can be used with a variety of external cameras; however, medical cameras must be used by a Health Care Professional.

  • Page 129: Hearing

    Screening hearing test using pure tone method. Indicated for pediatric, adolescent and adult only. Patients must be 6 years of age or older. Disconnect the headphones from the IDM100 Medical Tablet prior to defibrillation. The headphones are not considered a defibrillation-proof applied part and may cause injury if connected during defibrillation.
  • Page 130 2. Ensure that the headphones are connected to the device. If the Audiogram remote is connected, its image on the screen indicates connection. Use only the specific audiogram remote (see section 3.2 Connect Accessories). Title: DICTUM HEALTH IDM100 MEDICAL TABLET INSTRUCTIONS FOR USE DCO#: 00271 Document#: 870-00001-01...
  • Page 131 5. Ensure that the patient is wearing the headphones with the left and right ear pieces aligned correctly. 6. Tap START. The Audiogram Test screen appears. If the patient is not using an Audiogram remote, the screen appears as shown below: Title: DICTUM HEALTH IDM100 MEDICAL TABLET INSTRUCTIONS FOR USE DCO#: 00271 Document#: 870-00001-01...

  • Page 132: Hearing Test Results

    41 dB to 55 dB Moderately severe 56 dB to 70 dB Severe 71 dB to 90 dB Title: DICTUM HEALTH IDM100 MEDICAL TABLET INSTRUCTIONS FOR USE DCO#: 00271 Document#: 870-00001-01 Originating Author: E Keate Date Created: 9/04/2018 Revision: AR Page 132 of 175 Modifying Author: R.

  • Page 133: Maintain The Headphones

    • Do not allow the cleaning solution to enter into the earphone speaker. • Use earphones only when they are completely dry. Title: DICTUM HEALTH IDM100 MEDICAL TABLET INSTRUCTIONS FOR USE DCO#: 00271 Document#: 870-00001-01 Originating Author: E Keate Date Created: 9/04/2018...

  • Page 134: Glucose Meter

    Select the time period: 3 days, 1 week, or 1 month in the upper right. The currently selected choice is displayed in black. To exit the test, tap DONE. Title: DICTUM HEALTH IDM100 MEDICAL TABLET INSTRUCTIONS FOR USE DCO#: 00271 Document#: 870-00001-01...
  • Page 135 The Y axis shows 0 mg/dL to 400 mg/dL or 0 mmol/L to 24 mmol/L. If any measurement is above 400 mg/dL or 24 mmol/L, the Y axis increases to 550 mg/dL or 30 mmol/dL. Title: DICTUM HEALTH IDM100 MEDICAL TABLET INSTRUCTIONS FOR USE DCO#: 00271...
  • Page 136 A pop-up is displayed. Tap on other points on the graph without closing the pop-up. The currently selected point is displayed in orange. To close the pop-up, tap EXIT. Title: DICTUM HEALTH IDM100 MEDICAL TABLET INSTRUCTIONS FOR USE DCO#: 00271 Document#: 870-00001-01...
  • Page 137 IDM100 Medical Tablet and added to the database and the measurements table. Manual Data Entry 1. If you do not currently have a meter paired with the IDM100 Medical Tablet, enter the measurements manually. Tap ADD NEW. The entry form appears:...

  • Page 138: Glucose Test Results

    To close the Glucose Test screen and return to TESTS, tap DONE on either the table or the graph. The last measurement taken for the day is shown on the patient’s Test screen. Title: DICTUM HEALTH IDM100 MEDICAL TABLET INSTRUCTIONS FOR USE DCO#: 00271...

  • Page 139: Maintenance

    Maintenance The expected service life of the IDM100 Medical Tablet is 3 years. The expected service life of any accessory shipped with the IDM100 Medical Tablet is 90 days, unless labeled differently. Dictum Health will make available upon request, circuit diagrams, component part lists, descriptions, calibration instructions, or other information to assist service personnel to repair parts of the IDM100 Medical Tablet that are designated by Dictum Health as repairable by service personnel.
  • Page 140 4. Remove the battery from compartment and dispose of properly (20.4 Parts Disposal). 5. Replace the battery with a new Lithium-Ion replacement battery supplied by Dictum Health. Battery Manufacturer: Inspired Energy Smart Li-Ion 7.2 V rechargeable (Model #: NF2047DH29) Title: DICTUM HEALTH IDM100 MEDICAL TABLET INSTRUCTIONS FOR USE...

  • Page 141: Parts Disposal

    Parliament and the Council of the European Union on Waste Electronic and Electrical Equipment (WEEE). If this product is contaminated, this directive does not apply. See www.dictumhealth.com or contact Dictum Health Customer Service. Title: DICTUM HEALTH IDM100 MEDICAL TABLET INSTRUCTIONS FOR USE DCO#: 00271 Document#: 870-00001-01...

  • Page 142: Service Testing

    2. Tap SETTINGS. 3. Tap SERVICE. 4. Tap SERVICE MODE. 5. Select the desired service test. Instructions for conducting each service test follow. Title: DICTUM HEALTH IDM100 MEDICAL TABLET INSTRUCTIONS FOR USE DCO#: 00271 Document#: 870-00001-01 Originating Author: E Keate...

  • Page 143: Introduction To Nibp Service Testing

    21.1 Introduction to NIBP Service Testing Caution: Only qualified service personnel should perform the following tests on the equipment. The information in this section is intended to assist Dictum Health service personnel with performing service tests on the IDM100 Medical Tablet NIBP component.
  • Page 144 Ensure that the Hand Bulb Exhaust Valve is closed. 4. Increase the pressure to the normal NIBP range (approximately 280 mmHg) using the hand bulb. 5. Visually confirm that the measurement on the pressure device is within ± 3 % of the IDM100 Medical Tablet pressure gauge measurement.

  • Page 145: Nibp Leak Test

    The recommended pass criterion is 6 mmHg/minute with a 500 mL rigid volume. To manually perform a leak test: 1. Connect a manometer, volume, and the hand bulb to the module using “T” adapters. Title: DICTUM HEALTH IDM100 MEDICAL TABLET INSTRUCTIONS FOR USE DCO#: 00271 Document#: 870-00001-01...
  • Page 146 Test Sequence: • The pneumatic system reaches its pressure equilibrium point after 60 seconds. Title: DICTUM HEALTH IDM100 MEDICAL TABLET INSTRUCTIONS FOR USE DCO#: 00271 Document#: 870-00001-01 Originating Author: E Keate Date Created: 9/04/2018...
  • Page 147 Pressure value P2 is subtracted from P1, displaying the leak rate per minute. • “PASS” appears on screen for leak rates within the acceptable limit of 6 mmHg/minute. Title: DICTUM HEALTH IDM100 MEDICAL TABLET INSTRUCTIONS FOR USE DCO#: 00271 Document#: 870-00001-01...

  • Page 148: Nibp Overpressure Test

    Blood pressure cuffs have large variations in size and materials causing variability in leak test results. To limit this effect, use only a 500 mL rigid volume. Title: DICTUM HEALTH IDM100 MEDICAL TABLET INSTRUCTIONS FOR USE DCO#: 00271 Document#: 870-00001-01...
  • Page 149 2. Connect a manometer, volume, and the hand bulb to the module using “T” adapters. 3. Tap START to close the Control Valve and the Dump Valve. Ensure that the Hand Bulb Exhaust Valve is closed. Title: DICTUM HEALTH IDM100 MEDICAL TABLET INSTRUCTIONS FOR USE DCO#: 00271 Document#: 870-00001-01...
  • Page 150 • The valves open. • The pressure rapidly reduces to 0 mmHg. • The test ends. Title: DICTUM HEALTH IDM100 MEDICAL TABLET INSTRUCTIONS FOR USE DCO#: 00271 Document#: 870-00001-01 Originating Author: E Keate Date Created: 9/04/2018 Revision: AR Page 150 of 175 Modifying Author: R.
  • Page 151 10 mmHg. A “FAIL” message appears for pressure outside the passing criteria. The failure message includes the passing criteria for adults. 7. Tap DONE. Title: DICTUM HEALTH IDM100 MEDICAL TABLET INSTRUCTIONS FOR USE DCO#: 00271 Document#: 870-00001-01 Originating Author: E Keate...
  • Page 152 4. Increase the pressure to approximately 140 mmHg using the hand bulb. To stop the test at any time, tap STOP. 5. Slowly increase the pressure from 140 mmHg to the overpressure point. Title: DICTUM HEALTH IDM100 MEDICAL TABLET INSTRUCTIONS FOR USE DCO#: 00271 Document#: 870-00001-01...

  • Page 153: Spirometer Calibration Check

    “FAIL” appears for pressure outside the passing criteria. The failure message includes the passing criteria for neonates. 7. Tap DONE. 21.5 Spirometer Calibration Check Title: DICTUM HEALTH IDM100 MEDICAL TABLET INSTRUCTIONS FOR USE DCO#: 00271 Document#: 870-00001-01 Originating Author: E Keate...
  • Page 154 (ATS/ERS Task Force: Standardization of Lung Function Testing 2005. American Thoracic Society, European Respiratory Society) 1. Ensure that all clinical and patient users are logged out. 2. Select SETTINGS. Title: DICTUM HEALTH IDM100 MEDICAL TABLET INSTRUCTIONS FOR USE DCO#: 00271 Document#: 870-00001-01 Originating Author: E Keate...
  • Page 155 5. Insert a new Spiraflow Sensor into the Spiragrip. 6. Connect the Spiragrip plug to the Spirometer port of the IDM100 Medical Tablet. 7. Push the mouthpiece of the Spiraflow Sensor all the way into the 3 L calibration syringe to ensure a tight seal.
  • Page 156 15. Perform the Spirometer Calibration Check: 1) Push the plunger all the way in. 2) Pull the plunger all the way out, or until the test result message appears. Title: DICTUM HEALTH IDM100 MEDICAL TABLET INSTRUCTIONS FOR USE DCO#: 00271 Document#: 870-00001-01...
  • Page 157 Or, perform steps 3-16 with a new or another Spiragrip and a new Spiraflow. If this check fails, discontinue patient use of the Spirometer and contact Dictum Health Service. Use the Spirometer only if it passes the Spirometer Calibration Check.

  • Page 158: Standards And Compliance

    Standards and Compliance The IDM100 Medical Tablet adheres to the FDA Regulatory, IEC/AAMI, and ISO, and Federal Communications Commission (FCC) requirements. 22.1 General Compliance Safety, EMC, and Regulatory Compliance Agency Compliance Standard IEC/AAMI Edition, Medical electrical equipment — Part 1: General requirements for safety 60601-1 Medical electrical equipment —...

  • Page 159: Guidance And Emc Manufacturer's Declaration

    Dictum Health. The correction of interference caused by such unauthorized modification, substitution, or attachment will be the responsibility of the user.
  • Page 160 Electromagnetic Emissions The IDM100 Medical Tablet is intended for use in the electromagnetic environment specified below. The customer or user of the device should assure that it is used in such an environment. Electromagnetic environment – guidance Emissions test Compliance...
  • Page 161 (1.17) √P d= (2.23) √P power of transmitter (W) 0.01 0.11667 0.11667 0.23333 Title: DICTUM HEALTH IDM100 MEDICAL TABLET INSTRUCTIONS FOR USE DCO#: 00271 Document#: 870-00001-01 Originating Author: E Keate Date Created: 9/04/2018 Revision: AR Page 161 of 175 Modifying Author: R.
  • Page 162 NOTE If necessary to achieve the IMMUNITY TEST LEVEL, the distance between the transmitting antenna and the ME EQUIPMENT or ME SYSTEM may be reduced to 1 m. The 1 m test distance is permitted by IEC 61000-4-3. Title: DICTUM HEALTH IDM100 MEDICAL TABLET INSTRUCTIONS FOR USE DCO#: 00271 Document#: 870-00001-01...

  • Page 163: View The Regulatory Summary On The Idm100 Medical Tablet

    As an alternative to FM modulation, 50% pulse modulation at 18 Hz may be used because while it does not represent actual modulation, it would be worst case. 22.6 View the Regulatory Summary on the IDM100 Medical Tablet 1. Ensure that all clinical and patient users are logged out.
  • Page 164 4. Tap EXIT. Title: DICTUM HEALTH IDM100 MEDICAL TABLET INSTRUCTIONS FOR USE DCO#: 00271 Document#: 870-00001-01 Originating Author: E Keate Date Created: 9/04/2018 Revision: AR Page 164 of 175 Modifying Author: R. Massie Date Modified: 05/28/2020...

  • Page 165: Technical Specifications

    Initial Inflation Pressure: mmHg to 280 mmHg NEONATE: 90 mmHg (default) Variable from 60 mmHg to 140 mmHg Title: DICTUM HEALTH IDM100 MEDICAL TABLET INSTRUCTIONS FOR USE DCO#: 00271 Document#: 870-00001-01 Originating Author: E Keate Date Created: 9/04/2018 Revision: AR Page 165 of 175 Modifying Author: R.
  • Page 166 Accuracy: ± 3 % or 50 ML ATS/ERS Task Force: Standardization of Lung Function Testing 2005. Compliance American Thoracic Society European Respiratory Society Title: DICTUM HEALTH IDM100 MEDICAL TABLET INSTRUCTIONS FOR USE DCO#: 00271 Document#: 870-00001-01 Originating Author: E Keate Date Created: 9/04/2018...
  • Page 167 Charging temperature 0 °C to 54 °C (32 °F to 129.2 °F) Storage temperature -20 °C to 60 °C (-4 °F to 140 °F) Title: DICTUM HEALTH IDM100 MEDICAL TABLET INSTRUCTIONS FOR USE DCO#: 00271 Document#: 870-00001-01 Originating Author: E Keate...

  • Page 168: Clinical References

    18-25 Healthy Green 25-30 Overweight Yellow > 30 Obese Title: DICTUM HEALTH IDM100 MEDICAL TABLET INSTRUCTIONS FOR USE DCO#: 00271 Document#: 870-00001-01 Originating Author: E Keate Date Created: 9/04/2018 Revision: AR Page 168 of 175 Modifying Author: R. Massie Date Modified: 05/28/2020...

  • Page 169: Troubleshooting

    Troubleshooting The following table lists error and warning messages that may appear while operating the IDM100 Medical Tablet. Follow the corrective action to correct the problem. If you continue to experience problems, contact Dictum Health Service as follows: Dictum Health Inc.
  • Page 170 Unable to save medications. WARNING: Unable to save patient info. Unable to save problems. Unable to save allergies. Unable to save medications. Title: DICTUM HEALTH IDM100 MEDICAL TABLET INSTRUCTIONS FOR USE DCO#: 00271 Document#: 870-00001-01 Originating Author: E Keate Date Created: 9/04/2018...

  • Page 171: Temperature Messages

    30 seconds of inactivity. Any changes are saved. (Save the Biotech Settings before using the device again.) Title: DICTUM HEALTH IDM100 MEDICAL TABLET INSTRUCTIONS FOR USE DCO#: 00271 Document#: 870-00001-01 Originating Author: E Keate Date Created: 9/04/2018...

  • Page 172: Blood Pressure Messages

    Check that the correct size cuff is being applied. Check that there is no excessive clothing between arm and cuff. Title: DICTUM HEALTH IDM100 MEDICAL TABLET INSTRUCTIONS FOR USE DCO#: 00271 Document#: 870-00001-01 Originating Author: E Keate Date Created: 9/04/2018...
  • Page 173 Service may be required. If possible, perform calibration. failure. Contact Service. WARNING: MOSFET Failure. Contact Service. Title: DICTUM HEALTH IDM100 MEDICAL TABLET INSTRUCTIONS FOR USE DCO#: 00271 Document#: 870-00001-01 Originating Author: E Keate Date Created: 9/04/2018 Revision: AR Page 173 of 175 Modifying Author: R.

  • Page 174: Pulse Oximeter Messages

    Verify setup and repeat check. If check Follow the instructions in 21.5 fails again, discontinue use of Spirometer Calibration Spirometer and contact Service. Check. Title: DICTUM HEALTH IDM100 MEDICAL TABLET INSTRUCTIONS FOR USE DCO#: 00271 Document#: 870-00001-01 Originating Author: E Keate Date Created: 9/04/2018 Revision: AR Page 174 of 175 Modifying Author: R.

  • Page 175: Virtual Exam Messages

    Try again. If the problem persists, configuration. contact Service. WARNING Unable to create Virtual Error initializing Exam Title: DICTUM HEALTH IDM100 MEDICAL TABLET INSTRUCTIONS FOR USE DCO#: 00271 Document#: 870-00001-01 Originating Author: E Keate Date Created: 9/04/2018 Revision: AR Page 175 of 175 Modifying Author: R.

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