Dictum Health IDM100 Instructions For Use Manual Download

Page: 1 / 175

Title:

DICTUM HEALTH IDM100 MEDICAL TABLET INSTRUCTIONS FOR USE

DCO#:

00271

Document#:

870-00001-01

Originating Author:

E Keate

Modifying Author:

R. Massie

Date Created:

9/04/2018

Date Modified:

05/28/2020

Revision:

Page

1 of 175

IDM100 Medical Tablet Instructions for Use

Summary of Contents for IDM100

Page 1: ...AL TABLET INSTRUCTIONS FOR USE DCO 00271 Document 870 00001 01 Originating Author E Keate Modifying Author R Massie Date Created 9 04 2018 Date Modified 05 28 2020 Revision AR Page 1 of 175 IDM100 Med...

Page 2: ...Network LAN 18 3 6 Connect to a Wi Fi Network 19 3 6 1 Connect to a Wi Fi Network With Broadcasting SSID 20 3 6 2 Connect to a Wi Fi Network Without Broadcasting SSID 21 3 6 3 Connect to Wi Fi Using...

Page 3: ...Medication to a Patient Record 55 5 8 Work with the Current Patient 57 5 9 Edit a Patient Record 58 5 10 Notes 59 5 11 Feedings 60 5 12 Conduct a Test on a Patient 61 6 VIRTUAL EXAM 64 6 1 Initiate a...

Page 4: ...s 95 14 3 BTPS Entry 96 14 4 Spirometer Test 97 14 5 Spirometer Maintenance 102 15 ELECTROCARDIOGRAPH 103 15 1 WARNINGS AND CAUTIONS 103 15 2 ECG Status Messages 104 15 3 12 Lead ECG Test 105 15 4 12...

Page 5: ...t 148 21 5 Spirometer Calibration Check 153 22 STANDARDS AND COMPLIANCE 158 22 1 General Compliance 158 22 2 General Radio Compliance 158 22 3 Guidance and EMC Manufacturer s Declaration 159 22 4 EMC...

Page 6: ...utions are the same for the tests regardless of how their interfaces are displayed The IDM100 integrated Medical Tablet applications range from routine screening in ambulatory care facilities to physi...

Page 7: ...al hemoglobin SpO2 pulse rate and optional Respiratory Rate Electronic Stethoscope for acquiring and monitoring of auscultation signals from the attached chest piece Spirometry captures displays store...

Page 8: ...ce Screening hearing test using pure tone method Indicated for pediatric adolescent and adult only Patients must be 6 years of age or older Manual interface for height weight respiratory rate and othe...

Page 9: ...zard Use the USB connector and all signal input and output I O connectors only to connect to devices complying with IEC 60601 1 or other IEC standards as appropriate to the device The user is responsi...

Page 10: ...rs and other stimulators may be used simultaneously with the IDM100 Medical Tablet However such devices may disturb the device signal Carefully route cables to reduce the possibility of patient entang...

Page 11: ...entation Symbols WARNING Indicates conditions or practices that could lead to illness injury or death CAUTION Indicates an error condition or malfunction with the device Rx ONLY CAUTION Federal USA la...

Page 12: ...to be connected directly to the patient s heart Only surface contact with the patient s skin is intended IEC 60417 5336 Direct current IEC 60417 5031 IP21 Protected against solid foreign objects of 1...

Page 13: ...aneous Symbols Model number Serial number LAN MAC address Latex free No components of this package or the products it contains are made from natural rubber latex or dry natural rubber Do not re use Do...

Page 14: ...tery Do not power on the IDM100 Medical Tablet until after it is charged fully 1 To charge the battery plug the tip of the power cord into the power supply port on the left side of the device 2 Plug t...

Page 15: ...assie Date Created 9 04 2018 Date Modified 05 28 2020 Revision AR Page 15 of 175 Ports on the Right Side of the IDM100 Medical Tablet 1 Spirometer 2 Non invasive Blood Pressure NIBP 3 Thermometer 4 EC...

Page 16: ...escribed below Suntech Eclipse NIBP Cuffs Pediatric Small Adult Adult and Large Adult sized cuffs with 121 92 cm 4 ft hose and female bayonet connector Covidien Genius 2 Tympanic Temperature Thermomet...

Page 17: ...wraps Dura Y Oxygen Transducer 1 sensor 40 wraps OxiMax Adult Sensor single use 24 cs Ear Clip use with Dura Y sensor OxiMax Pediatric Sensor single use 24 cs PediCheck Pediatric Spot Check use with D...

Page 18: ...DM100 Medical Tablet 1 Press the power button in the lower left corner of the front of the device 2 Keep the device powered on and plugged in for setup To power off the IDM100 Medical Tablet 1 Press a...

Page 19: ...of 175 The LAN icon in the upper right corner appears when the LAN is active 3 Tap the LAN icon to view the LAN status The Ethernet Status screen appears 4 Tap Test to verify the connection If the co...

Page 20: ...ith Broadcasting SSID If your network s SSID is not broadcast see section 3 6 2 Connect to a Wi Fi Network Without Broadcasting SSID To connect with WPS see section 3 6 3 Connect to Wi Fi Using WPS Th...

Page 21: ...of 175 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 Co...

Page 22: ...e 22 of 175 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...

Page 23: ...Cancel to stop WPS When the IDM100 Medical Tablet is connected the network status shows Connected and the Wi Fi icon turns green 3 7 Register the IDM100 Medical Tablet Prior to using your new IDM100 M...

Page 24: ...ifying Author R Massie Date Created 9 04 2018 Date Modified 05 28 2020 Revision AR Page 24 of 175 2 Enter the User ID and Password provided by your administrator 3 Tap REGISTER The message Retrieving...

Page 25: ...inutes to 2 hours depending on the amount of data The Login screen appears after the database has been updated Verify that appears indicating that the Dictum Health server is connected If appears indi...

Page 26: ...e 26 of 175 The Login screen appears 2 Enter your username and password 3 Tap LOGIN The Home Screen appears 3 9 Home Screen The Home screen provides the main menu options for working with patients set...

Page 27: ...ist of all patients New Patient Enter a new patient record Virtual Exam Initiate a Virtual Exam with a physician Settings View and change device settings IFU View the Instructions for Use IFU 3 10 Tou...

Page 28: ...een until the desired action is completed 3 11 Set Up the BAR 228 for Spirometry The required Oregon Scientific BAR 228 Weather Station provides ambient pressure temperature and humidity For more info...

Page 29: ...e 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 For Servers s...

Page 30: ...018 Date Modified 05 28 2020 Revision AR Page 30 of 175 2 Tap Video Conferencing Server to view its settings 3 Tap Mobile Sync Server to view its settings 4 2 Medical Device Settings This section desc...

Page 31: ...e section 4 2 1 ECG Settings For Temperature see section 4 2 2 Temperature Settings For Glucose Meter see section 4 2 3 Glucose Meter For Spirometer see section 4 2 4 Spirometry Settings For NIBP see...

Page 32: ...erference 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 If interf...

Page 33: ...Created 9 04 2018 Date Modified 05 28 2020 Revision AR Page 33 of 175 B To use the Fora IR20b temperature probe Select Ear for Default Probe Select Auto for Default Entry Select On for Bluetooth LE I...

Page 34: ...175 When the Fora IR20b appears tap OK To view paired devices at any time tap the Bluetooth icon The Fora IR20 information is displayed under Saved Devices For more information see section 4 4 2 Bluet...

Page 35: ...oth LE On If a Bluetooth glucose meter is used to transfer glucose measurements automatically from the meter select On This enables the Find Glucose Meter button and allows you to select and pair the...

Page 36: ...pin entry pops up 6 Enter the PIN displayed on the glucose meter and then tap OK To view paired devices at any time tap the Bluetooth icon The glucose meter information is displayed under Saved Device...

Page 37: ...res using the BAR 228 which determines and auto enters the required values when initiating Spirometry or Spirometer Calibration Check 1 To use the BAR 228 Prepare the BAR 228 if it is not ready see se...

Page 38: ...o enter BTPS manually Select MANUAL Enter Ambient Pressure Temperature and Humidity see section 14 3 BTPS Entry Enter barometric pressure as given by a barometer in the immediate vicinity Do not enter...

Page 39: ...sition For information on Vitals see section 13 Vitals 4 2 6 Scale Settings 1 Tap Scale The selection expands to display the Scale settings 2 Select whether to use the Bluetooth scale A To enter weigh...

Page 40: ...p Stethoscope The selection expands to display the Stethoscope settings 2 Select the stethoscope from the list If you select a Bluetooth stethoscope Littman go to the next step 3 Tap FIND STETHOSCOPE...

Page 41: ...l Device successfully paired is displayed 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 appe...

Page 42: ...Author E Keate Modifying Author R Massie Date Created 9 04 2018 Date Modified 05 28 2020 Revision AR Page 42 of 175 2 Follow the applicable instructions to view and change general settings 4 3 1 Unit...

Page 43: ...lt camera Front Back or External 4 Select the Interference Filter 50 Hz or 60 Hz default To ensure the best signal quality check the AC frequency used in the region you are located 4 3 3 Brightness Ad...

Page 44: ...5 28 2020 Revision AR Page 44 of 175 2 Select the desired elapsed time for session timeout 4 3 5 About To view device hardware and software details tap About 4 4 Action Bar Settings Settings on the to...

Page 45: ...m action bar The Date and Time Settings screen appears 2 Tap Settings The Date and Time settings screen appears 3 Set the date and time manually or automatically A To use Automatic date and time Tap A...

Page 46: ...8 2020 Revision AR Page 46 of 175 B To set the date and time manually If a checkmark appears in the checkbox next to the Automatic date time option tap to uncheck it Tap Set date The Set date screen a...

Page 47: ...mat To use 24 hour format tap to select it A checkmark appears To use 12 hour time format tap to uncheck the selection Tap Choose date format and then select the desired date format All dates appear i...

Page 48: ...n The Wi Fi Status screen appears The Enable Wi Fi switch shows the selected status On Yes or Off No The Status shows whether the device is connected If the device is connected the name of the connect...

Page 49: ...odifying Author R Massie Date Created 9 04 2018 Date Modified 05 28 2020 Revision AR Page 49 of 175 4 4 5 Battery Tap the Battery Status icon The Battery Status screen appears 4 4 6 Cast Screen Tap th...

Page 50: ...new patient record View a list of patient records View a list of patients scheduled for the day by appointment time Review and update a patient record Initiate tests on patients whether working with...

Page 51: ...you can Scroll the list up or down Enter a patient s name in the Search field Select a letter from the list of initials to display the patients whose names begin with the selected letter 5 3 Download...

Page 52: ...ownloading If you do not want to download a record tap to remove the X Only selected records are downloaded 4 Tap Confirm to download the selected patient records After the download has completed the...

Page 53: ...Modifying Author R Massie Date Created 9 04 2018 Date Modified 05 28 2020 Revision AR Page 53 of 175 2 Tap ADD NEW PROBLEM The Category menu appears 3 Select the correct category on the left A menu of...

Page 54: ...Page 54 of 175 To delete a symptom tap the Delete icon for that symptom 6 To add another problem tap Add New Problem and repeat the previous steps 7 Tap SAVE 5 6 Add an Allergy to a Patient Record 1 T...

Page 55: ...of 175 4 Tap ADD The selected allergy information is saved to the patient record To delete an allergy tap the Delete icon for that allergy 5 To add another allergy tap Add New Allergy and repeat the p...

Page 56: ...the search field 4 Select the medication name from the list 5 Select the appropriate medication information from each drop down menu When selecting the start and end dates scroll the calendar view up...

Page 57: ...on The Edit Medication screen appears 11 Change the information as required and then tap OK 5 8 Work with the Current Patient If the patient record has not been created see section 5 4 Create a New Pa...

Page 58: ...on A pop up menu appears 4 Select the appropriate option Tap Open Record to open the Current Patient s record for viewing or editing Tap Tests to conduct tests on the Current Patient Tap Close Record...

Page 59: ...tient Record To edit allergy information see section 5 6 Add an Allergy to a Patient Record To edit medication information see section 5 7 Add a Medication to a Patient Record To edit feeding informat...

Page 60: ...a patient record is added to the NOTES button in the patient record as shown below The notification badge disappears after you view the notes The new note notification is added to the Patient List ic...

Page 61: ...te Created 9 04 2018 Date Modified 05 28 2020 Revision AR Page 61 of 175 The Feedings screen appears 3 Tap ADD NEW FEEDING 4 Enter the feeding information and tap SAVE 5 12 Conduct a Test on a Patient...

Page 62: ...n and select Tests Tap TESTS from the Patient Record screen The TESTS menu appears The tests available on this menu are based on the configuration established by your administrator for the IDM100 Medi...

Page 63: ...2018 Date Modified 05 28 2020 Revision AR Page 63 of 175 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 Medi...

Page 64: ...ns for Use where an HCP must be physically present with the subject for both audiometry and spirometry 6 1 Initiate a Virtual Exam Virtual Exam conference audio is temporarily suspended during stethos...

Page 65: ...lable for a virtual exam call are represented by a green Call icon on the Virtual Exam screen If a Call icon is orange long press the icon to display the corresponding clinician s status 4 To begin a...

Page 66: ...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 t...

Page 67: ...ual Exam Icons and Button Controls In Audio Only mode tap the VER Video Exam Room button to turn on video and audio Tap the End button to end the Virtual Exam Tap the Signal Strength meter to display...

Page 68: ...option to end the Virtual Exam Selecting a new patient will end call Continue Confirm to terminate the current Virtual Exam and select new patient Adding a new patient will end call Continue Create a...

Page 69: ...t will not influence gain adjustment if needed Use the gain on the stethoscope screen to set a moderate recording level of not too loud and not too soft for the best quality recording Stethoscope audi...

Page 70: ...1 Verify that you have selected the correct patient 2 Review the Instructions for Use IFU To view the IFU before you conduct a test tap the IFU icon on the Home screen 7 1 Navigating the IFU 1 Tap IF...

Page 71: ...ilable for the selected text IFU and Caution icons appear in the bottom action bar Select the desired icon and the corresponding information appears 1 To view test specific instructions tap the IFU ic...

Page 72: ...physician to evaluate the results and save the results to the patient s record The applicable sections in this IFU summarize how to evaluate the test results Test results are saved to the patient rec...

Page 73: ...luetooth Scale 1 Ensure that the Bluetooth scale is paired with the tablet For information on pairing the scale see section 4 2 6 Scale Settings 2 Tap the Weight Height test icon 3 Ask the patient to...

Page 74: ...ts except for infants 3 Scroll the dials up or down to select the weight and height Stop when the correct weight and height values are highlighted by the blue strips 4 Tap DONE The Weight and Height r...

Page 75: ...he Genius 2 Tympanic Thermometer should be placed in the thermometer base unit The Genius 2 Tympanic Thermometer should not be used on patients with ear drainage blood cerebrospinal fluid vernix ear w...

Page 76: ...ol wipe such as Webcol Alcohol Preps or Curity Alcohol Preps Remove all foreign matter from the thermometer probe tip Dry the probe tip lens using a lint free swab cotton ball or lens wipe Ensure that...

Page 77: ...elsius or Fahrenheit Press and hold the C F button to switch between Celsius and Fahrenheit To wake the thermometer from sleep mode after 30 40 seconds of non use Eject the attached probe cover and or...

Page 78: ...5 The Temperature Test screen appears 2 Power on the ForaIR20b and take the patient s temperature according to the Fora IR20b s Instructions for Use 9 5 Manual Temperature Test 1 Tap the Temperature t...

Page 79: ...Results The Temperature Results screen appears after the test has completed after the triple beep signal by the Genius 2 or after you have manually entered the temperature 1 Review the results If the...

Page 80: ...d Pressure NIBP component offers 3 types of blood pressure measurement categories divided by patient population These patient groups are formally defined as neonate up to 28 days old pediatric 29 days...

Page 81: ...signs of prolonged impairment of patient circulation Applying the cuff over a wound can cause further injury A compressed or kinked connection hose may cause continuous cuff pressure resulting in blo...

Page 82: ...e patient should be seated or lying down If the patient is seated they should have legs uncrossed feet flat on the floor and back and arms supported The patient should be comfortable relaxed as much a...

Page 83: ...e setting based on the patient s information The initial inflation pressure defaults to the appropriate setting for that mode or the previous value for the current patient 3 To change any automatic or...

Page 84: ...The Blood Pressure Cuff setup screen appears 7 Important Use the range guide on the inside of the cuff to confirm that the cuff is the correct size for the patient 8 Wrap the cuff around the location...

Page 85: ...hor E Keate Modifying Author R Massie Date Created 9 04 2018 Date Modified 05 28 2020 Revision AR Page 85 of 175 11 Tap SAVE The test results are saved to the patient record and the TESTS summary scre...

Page 86: ...aterial Because individual skin conditions affect the ability of the skin to tolerate sensor placement it may be necessary to change the sensor site with some patients If skin integrity changes move t...

Page 87: ...sure that the position of the sensor is correct Correct or try a different finger other than index if needed If an index finger cannot be positioned correctly or is not available use a smaller finger...

Page 88: ...nsor does not track the pulse reliably check the following o The sensor may be positioned incorrectly o The sensor site may be too thick or thin o The sensor site may be deeply pigmented o The sensor...

Page 89: ...nt 870 00001 01 Originating Author E Keate Modifying Author R Massie Date Created 9 04 2018 Date Modified 05 28 2020 Revision AR Page 89 of 175 Auto Mode Manual Mode 5 Tap SAVE The test results are sa...

Page 90: ...05 28 2020 Revision AR Page 90 of 175 12 Respiratory Rate 1 Tap the Respiratory Rate test icon 2 Tap START 3 Count the patient s breaths during the timer countdown The timer stops at 60 seconds 4 To s...

Page 91: ...0271 Document 870 00001 01 Originating Author E Keate Modifying Author R Massie Date Created 9 04 2018 Date Modified 05 28 2020 Revision AR Page 91 of 175 6 Tap SAVE The test results are saved to the...

Page 92: ...Pain Level using a multi interface screen 1 Tap Vitals on the TESTS screen The Vitals screen appears 2 Select the Current Patient 3 Prepare Place the correct size of NIBP cuff on the patient Tap the...

Page 93: ...ry Rate Tap in the RR field The RR entry menu appears Tap START to begin the timer which beeps every 15 seconds Count breaths until the timer stops automatically or until you tap STOP Select the count...

Page 94: ...in spirometric measurements Spirometry tests are not to be administered by a patient Calibration checks are not to be administered by a patient To minimize chances of a misdiagnosis it is the physicia...

Page 95: ...o prevent contamination Perform the Spirometer Calibration Check procedure in 26 5 of this document each testing day prior to testing Use the Spirometer only if it passes the Spirometer Calibration Ch...

Page 96: ...ion 2012 Equations Quanjer P H Stanojevic S Cole T J Baur X Hall G L Enright P L Hankinson J L Ip M S Zheng J Stocks J on behalf of the ERS Global Lung Function Initiative European Respiratory Journal...

Page 97: ...isted on internet sites on meteorological data resources Enter BTPS in Spirometer Settings o At least once daily the IDM100 Medical Tablet will request that you enter the BTPS values every 24 hours o...

Page 98: ...iving a passing result from the Spirometer Calibration Check For more information see section 21 5 Spirometer Calibration Check 2 Tap the Spirometer test icon 3 Perform entry of BTPS as described in s...

Page 99: ...thor E Keate Modifying Author R Massie Date Created 9 04 2018 Date Modified 05 28 2020 Revision AR Page 99 of 175 Align sensor notch with blue tab Push sensor to snap in place Ensure that the patient...

Page 100: ...the system is configuring When configuration is complete the Spirometer test screen appears 6 The patient performs the actions listed on the screen Take a deep breath inhaling to completely fill lungs...

Page 101: ...stered but then the system time outs before the inhalation The test results screen appears Flow rates for inhalation and exhalation are plotted on the resulting graph The graphed data of each test is...

Page 102: ...and the Best Effort screen appears The system selects and highlights the best effort 13 The administering health care professional can select an alternative test as the best effort by tapping on the...

Page 103: ...IDM100 Medical Tablet electrocardiography component is intended for use only by trained operators The IDM 100 allows a trained operator to acquire ECG Electrocardiograph waveforms using the ECG front...

Page 104: ...esult in AC power line frequency and interference on the ECG trace DO NOT pull or stretch the electrodes Doing so could result in mechanical or electrical failures Store each set of ECG cable and elec...

Page 105: ...higher than the heart and legs Prepare the patient for electrode placement If necessary shave the electrode placement area on the patient s skin Clean the electrode placement area with alcohol or acet...

Page 106: ...05 28 2020 Revision AR Page 106 of 175 Connect the electrodes and lead wires as specified on the Electrode Placement screen 3 Ensure that each electrode is connected correctly on the patient After eac...

Page 107: ...he ECG signals to stabilize and the first few square type waveforms to pass if necessary make adjustments before recording the ECG Ensure that the view and settings are set as necessary Confirm that I...

Page 108: ...the 10 second timer commences recording When the ECG recording is finished the ECG Test Results screen appears Caution Electrodes may disconnect during the ECG occurring more frequently with leg elect...

Page 109: ...rements could be affected due to patient or system related issues examples when there are no p or t waves if noise artifacts or out of range results occur or if the ECG waveform cannot generate a norm...

Page 110: ...s QT QT interval uncorrected milliseconds ms QTCb QT interval corrected with Barret s formula milliseconds ms QTCf QT interval corrected with Frederica s formula milliseconds ms 1 Review the ECG resul...

Page 111: ...E Keate Modifying Author R Massie Date Created 9 04 2018 Date Modified 05 28 2020 Revision AR Page 111 of 175 Report Default 4 3 2 6 1 12 D Use the calipers to confirm data of a user selected area on...

Page 112: ...ed on the black labels to confirm see below 2 The confirming physician assesses the ECG results in preparation for adding the ECG assessment to the patient s record The ECG test depends upon a qualifi...

Page 113: ...AV Block Sinus Rhythm 8 First Degree AV Block Sinus Bradycardia 9 Second Degree AV Block 10 Premature Atrial Contraction 11 Supraventricular Tachycardia 12 Atrial Fibrillation Flutter SVR 13 Atrial Fi...

Page 114: ...2 Lead ECG Results Summary screen with measurements Tap the icon to return to the Save Results screen 15 5 3 Lead ECG Test Ensure that the ECG Options in the Medical Device Settings menu are set For m...

Page 115: ...Electrode Placement screen appears and prompts you to connect the electrodes to the patient 2 Attach all electrodes and lead wires securely Use the information in the table and diagrams below Observe...

Page 116: ...tached the electrode status turns green on the Electrode Placement screen A red electrode status indicates that the corresponding electrode is disconnected Before you can continue properly connect eac...

Page 117: ...Ensure that the view and settings are set as necessary Confirm that Perform if needed Pace Detect set as desired By default Pace Detect is on displaying pacemaker spikes as dashed blue lines Tap Off t...

Page 118: ...odes may disconnect during the ECG Ensure all connections are intact after recording 15 6 3 Lead ECG Test Results After the ECG recording concludes the ECG test results screen appears If interpretatio...

Page 119: ...ect the electrodes from the patient If interpretation is enabled in ECG Settings the following parameters are returned as numeric data on the ECG test results screen Parameter Abbreviation Parameter R...

Page 120: ...175 Use the screen and report views when needed to customize how the data is displayed To do this A Select a different report view type Report is the default B Select Single Lead if necessary Tap a l...

Page 121: ...pers on Zoom in to the desired view Drag the horizontal and vertical paddles of the calipers to frame the area Read the data displayed on the black labels to confirm see below 2 The confirming physici...

Page 122: ...Sinus Rhythm IVCD 31 Sinus Bradycardia 32 Sinus Bradycardia IVCD 33 Sinus Tachycardia 34 First Degree AV Block Sinus Rhythm 35 First Degree AV Block Sinus Bradycardia 36 Second Degree AV Block 37 Pre...

Page 123: ...ision AR Page 123 of 175 4 Enter comments optional in the Add Comment box Tap the Add your initials box to enter your Initials Tap CONFIRM 5 Tap SAVE The ECG Results Summary screen appears Below is an...

Page 124: ...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 consi...

Page 125: ...4 2018 Date Modified 05 28 2020 Revision AR Page 125 of 175 5 Select type Bell or Diaphragm 6 Tap START 7 Optionally change the GAIN by selecting Low Med or High to optimize the audio volume for the t...

Page 126: ...018 Date Modified 05 28 2020 Revision AR Page 126 of 175 The Stethoscope results screen appears The y axis in the graph is normalized relative to the full scale output 9 Review the results 10 To enter...

Page 127: ...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 Tap the Camera icon from the Tests screen 2 Select t...

Page 128: ...ture Photo icon 6 Enter a title and description for the image 7 Tap SAVE The image is saved to the patient record To connect an external medical camera to the IDM100 Medical Tablet 1 Plug an external...

Page 129: ...may cause injury if connected during defibrillation 18 2 Prepare for a Hearing Test Prepare the patient and testing environment to perform the test Ensure that the patient has not experienced high lev...

Page 130: ...d 05 28 2020 Revision AR Page 130 of 175 1 Tap the Audiogram test icon The Audiogram screen appears indicating whether the headphones and Audiogram remote are connected 2 Ensure that the headphones ar...

Page 131: ...RANGE optional to adjust Decibel and Frequency ranges The Test and Frequency ranges screen appears 4 Slide the paddles to frame the desired range s and tap SAVE The Audiogram setup screen appears 5 E...

Page 132: ...ps the Tap area on the screen if not using a remote or pushes the button on the Audiogram remote when a tone is heard The patient can pause the test by tapping PAUSE or cancel the test by tapping CANC...

Page 133: ...at all in situations beyond what the above table shows the result is not reported To save the results tap SAVE The test results are saved to the patient record and the TESTS summary screen for the pat...

Page 134: ...rmation on configuring the settings see section 4 2 Medical Device Settings 2 If Bluetooth LE is set to Off in Settings or if it is set to On and a glucose meter has been paired the Glucose Test scree...

Page 135: ...splayed in normal text and cannot be edited If mmol l units are selected in settings mmol L is displayed in the GLUCOSE column title and glucose measurements are converted to mmol L 1 mg dL 18 018018...

Page 136: ...6 of 175 When mmol L units are selected in Settings the Y axis shows 0 to 24 and measurements are converted to mmol L Viewing Measurements To display a measurement s glucose concentration date and tim...

Page 137: ...ile the Glucose Test is running all measurements stored on the meter are immediately transferred to the IDM100 Medical Tablet If you take a new measurement on the meter while the test is running the m...

Page 138: ...me default to the current date and time Change the date and time if necessary 4 You can select an event to associate with the measurement from the Event drop down menu Before Meal After Meal Fasting S...

Page 139: ...nections reseat if any connectors are loose 20 2 Cleaning CAUTIONS To prevent the spread of infection the IDM100 Medical Tablet and patient cables must be kept clean especially patient contacting comp...

Page 140: ...mproper handling of the battery can lead to heat generation smoke bursting or fire Do not remove the label from the battery Do not disassemble modify or solder the battery Do not directly connect or s...

Page 141: ...old battery appropriately In the USA call 1 800 SAV LEAD for instructions on recycling it or visit International users contact your local authorities concerning recycling Discard the electrocardiograp...

Page 142: ...assie Date Created 9 04 2018 Date Modified 05 28 2020 Revision AR Page 142 of 175 21 Service Testing To perform IDM100 Medical Tablet service tests 1 Ensure that all clinical and patient users are log...

Page 143: ...ease contact Dictum Health if you have any questions 21 2 NIBP Pump Pressure Test Prepare to manually perform a pump pressure accuracy test 1 Stage equipment for the test Calibrated Manometer optional...

Page 144: ...sion AR Page 144 of 175 2 Tap NIBP Pump Pressure on the SERVICE menu 3 Tap START to close the Control Valve and the Dump Valve Ensure that the Hand Bulb Exhaust Valve is closed 4 Increase the pressure...

Page 145: ...ended Hand Bulb Connection Tubing Timer for example a stop watch 2 Understand the role of volume and cuffs in the test A 500 mL volume is recommended to prevent exaggerated leak rates with extremely s...

Page 146: ...at will not cause unwanted overpressure errors 300 mmHg To stop the time at any time tap STOP 3 Increase the pressure to approximately 250 mmHg using the hand bulb or the pump on the module 3 Minute S...

Page 147: ...e Modified 05 28 2020 Revision AR Page 147 of 175 The pneumatic pressure level is recorded P1 after the initial 60 seconds A second pneumatic pressure P2 is recorded after an additional 60 seconds 4 V...

Page 148: ...Prepare to perform an Overpressure test 1 Stage the equipment for the test Calibrated Manometer optional may use pressure values supplied by NIBP module Pneumatic T Adapters Volume 500 mL rigid bottl...

Page 149: ...10 for 15 seconds or greater than 10 for 3 seconds Overpressure pass criteria for the IDM100 Medical Tablet Adults Pediatrics 300 mmHg 10 mmHg Neonates 150 mmHg 5 mmHg 4 Understand the role of volume...

Page 150: ...eated 9 04 2018 Date Modified 05 28 2020 Revision AR Page 150 of 175 4 Increase the pressure to approximately 280 mmHg using the hand bulb To stop the test at any time tap STOP 5 Slowly increase the p...

Page 151: ...uthor R Massie Date Created 9 04 2018 Date Modified 05 28 2020 Revision AR Page 151 of 175 6 View the results A PASS message appears if the pressure meets the passing criteria of 300 mmHg 10 mmHg A FA...

Page 152: ...Perform an Overpressure Test in Neonate Mode 1 Select Neonatal 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 E...

Page 153: ...ision AR Page 153 of 175 When the overpressure point is reached the valves open and the pressure rapidly reduces to 0 mmHg completing the test 6 View the results PASS appears if the pressure meets the...

Page 154: ...ibration Check is to be performed by the HCP only The Spirometer Calibration Check is not to be performed by a patient Spirometer Calibration Checks may be affected by air blockage and movement of the...

Page 155: ...alibration Check Setup screen appears 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 S...

Page 156: ...Spirometry Settings 14 3 BTPS Entry The BAR 228 auto enters the atmospheric pressure as indicated by the animation 12 Confirm entry of atmospheric pressure from the BAR 228 prior to proceeding with th...

Page 157: ...the Spiraflow and discard properly Fail 1 Tap EXIT 2 Detach the Spiraflow and discard properly 3 Perform steps 3 16 above to repeat the check with a new Spiraflow 4 If the second check fails discontin...

Page 158: ...ic safety and essential performance in home healthcare environment 60601 1 11 Medical electrical equipment Part 2 25 Particular requirements for the basic safety and essential performance of electroca...

Page 159: ...circuit different from that to which the receiver is connected Consult the dealer or an experienced radio TV technician for help Dictum Health is not responsible for any radio or television interfere...

Page 160: ...the purpose of wireless communication The radio is operated according to the requirements of various agencies including FCC 47 CFR 15 247 and R TTE Directive 2014 53 EU Electromagnetic Immunity The ID...

Page 161: ...Electromagnetic propagation is affected by absorption and reflection from structures objects and people a Field strengths from fixed transmitters such as base stations for radio cellular cordless tel...

Page 162: ...ropagation is affected by absorption and reflection from structures objects and people Test Specifications for ENCLOSURE PORT IMMUNITY to RF wireless communications equipment Test frequency MHz Band a...

Page 163: ...the uplink frequencies are included b The carrier shall be modulated using a 50 duty cycle square wave signal c As an alternative to FM modulation 50 pulse modulation at 18 Hz may be used because whil...

Page 164: ...TH IDM100 MEDICAL TABLET INSTRUCTIONS FOR USE DCO 00271 Document 870 00001 01 Originating Author E Keate Modifying Author R Massie Date Created 9 04 2018 Date Modified 05 28 2020 Revision AR Page 164...

Page 165: ...perature 16 C to 33 C 60 8 F to 91 4 F Storage temperature 25 C to 55 C 13 F to 131 F Accuracy Range Ambient temp Target temp Degree of Accuracy 25 C 77 F 36 7 C to 38 9 C 98 1 F to 102 F 0 1 C 0 2 F...

Page 166: ...tric and Neonate1 20 250 bpm 3 digits Low perfusion 20 250 bpm 3 digits 1 Saturation accuracy varies by sensor type See www Nellcor com for oximetry accuracy grid ECG Accuracy range 5 Sampling rate 50...

Page 167: ...7 2 V Battery type Lithium Ion Maximum recommended output current 6 A Battery capacity Operating Time 4 5 hours rechargeable 3 hours Lifetime battery charge cycles 10 years or 300 cycles Power supply...

Page 168: ...ues are only for patients 13 years of age and older Body Mass Index Source Measurement units Formula and Calculations Centers for Disease Control and Prevention Kilograms and meters or centimeters For...

Page 169: ...e of temperature operating range Device will shut down Wait for device to return to normal operating condition WARNING Device is shutting down Battery is depleted Tone Warning tone in diagnostic mode...

Page 170: ...C power Message Connect to AC power WARNING Unable to save allergies Unknown system error Retry If the error persists contact Service WARNING Unable to save allergies Unable to save medications WARNIN...

Page 171: ...sting environment or relocate the test WARNING Site mode is corrupted The site mode is corrupted Allow the device to power down and then enter Biotech mode to reset the site mode The biotech mode is a...

Page 172: ...heck that the cuff is in the correct position Check the patient Check that the cuff is properly tightened Check that there is no excessive clothing between arm and cuff Check that the correct size cuf...

Page 173: ...r loose WARNING Safety Timeout The patient may have been moving too much Check the patient Check that the cuff is in the correct position Take another BP reading WARNING Cuff Overpressure Possible pro...

Page 174: ...Host Software Error WARNING Pulse OX Control Board Error 25 5 ECG Messages Message Cause Corrective Action WARNING ECG Cable Error Cable not connected Cable type unknown Cable is faulty Check connect...

Page 175: ...Date Created 9 04 2018 Date Modified 05 28 2020 Revision AR Page 175 of 175 25 7 Virtual Exam Messages Message Cause Corrective Action WARNING Peer to peer connectivity is delayed or failed Please ch...

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