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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

Содержание IDM100

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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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