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GENESIS DM CLINICAL GUIDE

Appendix E: Medical Device Specifications

P.4510EN.01

12/5/2007

78

Appendix E: Medical Device Specifications

The following peripheral medical devices are compatible with the Genesis DM monitor. For instructions on
how to use any peripheral medical device, please refer to manufacturer’s product materials. Specifications
may be changed by individual manufacturers without notice from Honeywell HomMed.

ECG device

HealthFrontier

ecg@home (available in the U.S. and Canada only)

Glucose meters

LifeScan

OneTouch Ultra®

OneTouch Ultra InDuo®
OneTouch Ultra2®
LifeScan One Touch Basic®

LifeScan One Touch Profile®

Bayer

Ascensia Elite XL®
Ascensia Breeze®
Ascensia Breeze2®

Ascensia Contour®

Roche

Accu-Chek Advantage®
ACCU-CHEK Aviva®
ACCU-CHEK Compact™ Plus

Home Diagnostics, Inc.

Prestige IQ®
TrueTrack Smart System®

Peak flow meters

Ferraris

Piko-1 Peak Flow Meter®

Prothrombin meters

ITC

Hemosense

ProTime Microcoagulation System®

InRatio

Temporal temperature

Exergen

Temporal Scanner

Specifications

Refer to manufacturer manual for specifications for any approved Honeywell HomMed medical devices.

Genesis DM monitor

Compliance approvals

UL60601, CSA601, IEC 60601-1

Physical

Dimensions

Width:

7.0 inches (17.8 cm)

Height:

2.75 inches (7.0 cm)

Depth:

6 inches (15.2 cm)

Weight

Approximately 1.6 lbs. (0.73 kg)

Power

AC Power

Wall mount style medical grade power supply

Input of 105-125VAC, 60 Hz
Input of 230VAC, 50/60 Hz
Output of 24VDC @ 500mA with 4kV isolation

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Содержание GENESIS DM

Страница 1: ...Service Toll free 888 353 5404 Phone 262 252 5840 Fax 262 252 6105 Honeywell HomMed Corporate Offices Honeywell HomMed 3400 Intertech Drive Suite 200 Brookfield WI 53045 Phone 262 783 5440 Fax 262 252 6105 2007 2008 by Honeywell HomMed All rights reserved ...

Страница 2: ......

Страница 3: ...he monitor location Customer Service will make every attempt to resolve the issue over the phone Table of Contents Getting Started 1 Safety information 4 Equipment Overview 9 The Genesis DM monitor 9 Monitor ports 11 Side ports 12 Lithium battery 12 Other system equipment 12 Scales 13 NIBP 13 Programming the Genesis DM Monitor 15 Operations and Communications 15 Genesis DM Menus 15 Genesis DM Prog...

Страница 4: ...tine Maintenance 47 Cleaning the Genesis DM Monitor 47 Inspection 48 Calibration verification 48 Remote Upgrades 50 Peripheral Medical Devices 51 Health Frontier ecg home 52 Glucose Meters 56 Oximeter 60 Peak Flow Meters 62 Prothrombin Meters 64 Temporal Temperature 67 APPENDICES 69 Appendix A Subjective Questions 69 Appendix B Sleep Apnea Questions 74 Appendix C Prompt Text 75 Appendix D Genesis ...

Страница 5: ...and transmitted to a central site for retrospective clinician review evaluation and trending The Genesis DM monitor is not an emergency medical response device The monitor does not have auditory or visual alarms for out of limit parameters The Genesis DM monitor does not provide real time critical care monitoring of patient vital signs All data is transmitted to the LifeStream platform and Central...

Страница 6: ...ion and instructions for using compatible peripheral medical devices Appendixes Provides additional reference information Index Allows you to locate information using key words Special conventions The following table lists the conventions used in this manual This convention Identifies Function font Keys that you press on the keyboard sign between key names Keys that you press simultaneously START ...

Страница 7: ...dentify the equipment monitor scale or accessory and describe the problem in detail If the damaged item is a monitor or a scale have the model and serial number ready to give the Customer Service Representative when you call Monitor model and serial numbers are located on the bottom of the monitor Scale model and serial numbers are located on the side or bottom of the scale For repair of periphera...

Страница 8: ...n to preclude permanent impairment Term Level of risk Definition WARNING Major Could cause death or serious personal injury CAUTION Moderate May result in minor or moderate personal injury CAUTION Minor May result in equipment damage NOTE None Important information WARNING ELECTRICAL SHOCK Computer components contain sufficient voltage to cause death or serious injury DO NOT immerse in water or ot...

Страница 9: ...OT DEFIBRILLATOR PROOF Using the Genesis DM monitor on patients undergoing defibrillation may damage the monitor or peripheral equipment DO NOT use the monitor on patients undergoing defibrillation WARNING PHYSICAL HAZARD Please exercise care in the routing of external cables wires and hoses to avoid creating a tripping hazard DO NOT route cables across a walkway CAUTION SENSITIVE EQUIPMENT The mo...

Страница 10: ...HOSE DAMAGE Bending kinking or otherwise restricting the blood pressure hose can damage the hose or interfere with readings DO NOT bend or crimp the blood pressure hose Keep the hose free from furniture or other objects that could compress them CAUTION ELECTROMAGNETIC COMPATABILITY Electromagnetic compatibility of electrical equipment at very close distances to the Genesis DM has not been evaluate...

Страница 11: ...ach unauthorized medical equipment to the Genesis DM monitor When connecting this device to any instrument verify proper operation before clinical use Refer to the equipment s user manual for full instructions Any peripheral medical devices connected to the data interface must be certified according to the respective IEC standards IEC 60950 for data processing equipment or IEC 60601 1 for electrom...

Страница 12: ...new patient Please see cleaning procedures located in this manual The Honeywell HomMed scale is not a stand alone device The scale must be connected to a Honeywell HomMed monitor to operate CE Mark Marking by the symbol 0413 indicates compliance of this device to the Medical Device Directive 2007 47 EC Authorized Representative MDSS Burckhardtstr 1 30163 Hannover Germany When you set up a monitor ...

Страница 13: ...d duplex jack AC adapter power supply Power strip External Pulse Oximeter and Finger Probe optional The Genesis DM monitor The front of the monitor has a vacuum fluorescent display VFD surrounded by six function keys Each key is labeled and color coded for easy visual identification When you press the keys correctly the monitor beeps The volume of the beep matches the volume of the voice prompts T...

Страница 14: ...th YES key 3 Red STOP key Red STOP key stops blood pressure reading and deflates the cuff 4 Gray MANUAL key Gray MANUAL key enters Manual Mode Exits a menu in Setup Mode 5 Scale Displays weight 6 Blue RETEST key Blue RETEST key starts an unscheduled monitoring session Selects a menu option in Setup Mode 7 Black NO key Black NO key records a no answer DOWN scroll key in Setup Mode 8 White YES key W...

Страница 15: ...ect to available secure wireless networks without additional client setup In the event that the unit fails to connect automatically the user will receive a relevant error message The GPRS modem is external features a right angle antenna and connects to the monitor unit with a supplied cable to port COM A The wireless GPRS modem can ONLY be connected to the COM A port The wireless GPRS MUST be allo...

Страница 16: ...pts and customizable patient questions Sentry and previously released Genesis cards ARE NOT compatible with the Genesis DM 2 Non invasive blood pressure NIBP pneumatic port The NIBP pneumatic port with its quick release connector is the attachment site for the blood pressure hose Lithium battery The lithium battery maintains the memory clock and configuration for approximately five years You canno...

Страница 17: ...vailable upon request Pressures are calculated by a proprietary algorithm as follows Systolic The cuff pressure when an increase in oscillations is perceived Diastolic The cuff pressure when oscillations are no longer decreasing as pressure is released from the cuff Heart pulse rate is also collected with the blood pressure and that value is transmitted However it is only posted in LifeStream or t...

Страница 18: ... a variable affecting the accuracy of NIPB measurements To order cuffs refer to Appendix C Parts List Power supply and strip The AC adapter converts alternating current to direct current to power the monitor The adapter is medical grade and UL and IEC compliant The power strip provides 4 outlets ...

Страница 19: ...t you should go through each menu to verify that the entered numbers match the numbers given to you during your in service Genesis DM Menus The Genesis DM monitor displays menu names and options in the display face Because of the limited space you can only see one menu or menu option at a time as you scroll through available choices Entering Setup Mode opens the Main menu which offers eight menu o...

Страница 20: ...GENESIS DM CLINICIAN GUIDE Programming the Genesis DM Monitor P 4510EN 01 12 5 2007 16 Genesis DM Programming Guide ...

Страница 21: ...ation packet back to LifeStream If you haven t made a change to the Genesis DM but still wish to send a configuration packet to Lifestream press MANUAL then YES Alternately a change made at LifeStream will be sent to the customer s mailbox for download by the Genesis DM the next time it communicates to the mailbox If you are at the Genesis DM and are expecting that there is a configuration packet ...

Страница 22: ...oring application LifeStream o If it detects peripherals then it displays the current voice setting selection And the monitor then sends the final configuration to the monitoring application You can enter Setup Mode anytime the Genesis DM monitor is idle However if you are in Setup Mode during a scheduled report time the monitor will skip the monitoring session and will not transmit any informatio...

Страница 23: ...enu has an Exit option The Exit option takes you out of the current menu and returns you to the Main menu The Exit Setup Menu in the Main menu takes you out of Setup Mode and returns the monitor to idle mode To immediately exit Setup Mode at any time press START YES Scheduling frequency You may schedule how often Genesis DM collects weight questions and optional device data Scheduling options incl...

Страница 24: ...information about scheduled readings refer to the LifeStream Clinician Guide The Report Time displays in the format programmed in the Time Format menu a m p m or 24 hour format If you assign multi use status to a monitor make sure all of the monitor s Report Times are set to Off In the Time Menu scroll to the Report Time option that you wish to set 1 2 3 or 4 1 Press RETEST to enter Depending on t...

Страница 25: ...Menu option or press MANUAL to return to the Main menu or press START YES to exit Setup Mode Time Options Time in the format set in Time Format menu Default Present time for your time zone Access Level General The Time menu allows you to set the correct time If you need to reset the time follow the steps below 1 In the Time menu scroll to the Time option and press RETEST The hour blinks 2 Scroll t...

Страница 26: ...You can scroll to the next Time Menu option or press MANUAL to return to the Main menu or press START YES to exit Setup Mode Time Format Options a m p m or 24 hour format Default a m p m Access Level General You can set the monitor to display either 24 hour or a m p m time To change the format follow the steps below 1 In the Time Menu scroll to Time Format and press RETEST to enter The currently p...

Страница 27: ...the clock to accommodate the time change The USA default setting moves the clock forward one hour at 2 00 a m on the second Sunday in March and back one hour at 2 00 a m on the first Sunday of November The European setting EEC moves the clock forward one hour at 1 00 a m on the last Sunday in March and back one hour at 1 00 a m on the last Sunday of October If your locale does not have Daylight Sa...

Страница 28: ...to the next System Settings option or press MANUAL to return to the Main menu or press START YES to exit Setup Mode Scale Prompt Options OFF every time for or any combination of days _ _ Mo _ _ We _ _ Fr _ _ or only one time each day _ _ Mo _ _ We _ _ Fr _ _ Default Every day Su Mo Tu We Th Fr Sa Access Level General Scale Prompt allows you to turn the audio and text scale prompts off or turn the ...

Страница 29: ...ess RETEST to enter the setting You can scroll to the next System Settings option or press MANUAL to return to the Main menu or press START YES to exit Setup Mode Units Options English Lbs and F or Metric Kg and C Default Set to common usage for your locale Access Level General You can set the Genesis DM to display either English or metric units Genesis DM monitors should default to what is custom...

Страница 30: ... the desired inflation setting and press RETEST to accept the new setting You can scroll to the next System Settings option or press MANUAL to return to the Main menu or press START YES to exit Setup Mode Display Brightness Options Low Med High Default High Access Level General This menu allows you to adjust the brightness level of the VFD display To adjust the brightness level follow the steps be...

Страница 31: ...y With LifeStream a number of duplicate questions are available that have DSSM educational content attached For a list of all of the questions refer to Appendix A Subjective Questions or to the Genesis DM Field Reference The menu also offers a block of questions for sleep apnea It is an on off option only If you turn the option on the monitor will ask all twelve questions in the block ...

Страница 32: ...ion 7 of 51 is being presented first For the list of all questions refer to Appendix A Subjective Questions Question Time Options OFF every time for or any combination of days _ _ Mo _ _ We _ _ Fr _ _ or only one time each day _ _ Mo _ _ We _ _ Fr _ _ Default All days Access Level General Each question is followed by an option that allows you to set a question frequency The default is daily Howeve...

Страница 33: ...nished press MANUAL to return to the Main menu or press START YES to exit Setup Mode Password Without entering a password you will not be able to see or enter password protected menus or menu options The password protected menu options are found in the Service and Transmit menus All Genesis DM monitors use the same password If you do not know the password contact your supervisor Follow the steps b...

Страница 34: ...k the number against the one you received during your inservice 1 In the Transmit Menu scroll to the PIN Number option If the number is correct you can move to your next task However if it is incorrect press RETEST to enter the option The first digit blinks 2 Use YES or NO to scroll to the correct number and press RETEST to accept the value and move to the next digit 3 Repeat steps 2 and 3 until y...

Страница 35: ...f you want the monitor to transmit data to a remote site other than an ISP mailbox 1 In the Transmit menu scroll to the Transmit Mode option and press RETEST The current setting blinks 2 Press either YES or NO to scroll to the correct transmit mode and press RETEST to accept it You can scroll to the next Transmit Menu option press MANUAL to return to the Main menu or press START YES to exit Setup ...

Страница 36: ... of information to LifeStream Central Station ISP2 Prefix C The text string in the ISP2 Prefix field is prepended to the username for authentication purposes when connecting to the secondary ISP account for transmission of information to LifeStream Central Station ISP2 Realm C The text string in the ISP2 Realm field is appended to the username for authentication purposes when connecting to the sec...

Страница 37: ...cess the Genesis DM monitor to obtain specific diagnostic data and perform calibration tasks If you are asked to perform any tasks that require you to enter this menu Customer Service will walk you through the steps Service Call Choose this item to initiate a connection between the monitor and the Honeywell HomMed service department computer Service Call Phone C This item contains the number the m...

Страница 38: ...on of the monitor BP Safety Version C Reports the BP Safety version of the monitor BP Hardware Version C Reports the BP Hardware version of the monitor NIBP Cycles C Reports the number of NIBP cycles since Last Calibration C Reports the date of the last calibration of the monitor Exit Report Menu Exit the Service menu and return to the previous menu Load Factory Default C Returns the monitor to th...

Страница 39: ...table surface for the monitor located where the patient can sit comfortably at rest for the readings Select an area that allows the free flow of air around the monitor Ensure that a bed chair or other seating is readily available Be certain that the patient can easily attach any peripheral devices DO NOT Place any equipment near sources of water such as sinks or bathtubs Place on or near a heat so...

Страница 40: ...ace If the floor is carpeted make sure the bottom of the scale clears the carpet so that when the patient steps on the scale pressure is placed on the four feet that contain the load cells You can adjust the height of the scale by screwing the feet in or out To attach the Honeywell HomMed scale 1 Attach the scale cable to the scale first Locate the scale s DB 9 port at the top of the scale and ins...

Страница 41: ...click when it locks into place Attaching the modem CAUTION REQUIRES ANALOG PHONE LINE The modem requires an analog phone line A digital phone line may destroy the modem DO NOT use a digital phone line Verify presence of analog phone line prior to installation The modem connection is on the back of the Genesis DM monitor To connect the modem to the phone outlet follow the steps below 1 Unplug the p...

Страница 42: ...or walls Plug the AC adapter jack into the power input on the rear of the monitor Plug the power brick into an outlet on the power strip Make sure that the brick is flush with the strip Plug the power strip into a wall outlet Turn the strip s power switch on As soon the monitor powers up it displays the current software version If the monitor detects any problems the Genesis DM displays an error c...

Страница 43: ...ical emergency response device Instruct the patient on what to do in a medical emergency Reinforce that the patient is the only one who should use the monitor Explain that the LifeStream assumes that all information received from the monitor comes from the patient and posts the data in the patient s records Genesis DM Monitor Voice and Text Prompts Disease Specific Symptom Management The Genesis D...

Страница 44: ...patient ample time to perform requested tasks If the patient does not complete the request within the time frame allowed after the first prompt the monitor repeats the prompt up to three times At the beginning of a session the patient has thirty minutes to comply with the initial prompt to step on the scale During the thirty minutes the scale prompt is repeated at the rate of once every five minut...

Страница 45: ...ed as dashes A voice prompt instructs the patient to place the blood pressure cuff on the right arm above the elbow and tighten it securely Cue text Put cuff on arm An additional blood pressure prompt instructs the patient to rest their arm as instructed It is important that you show them where to place their arm to obtain the most accurate blood pressure reading Cue text Rest arm as instructed Th...

Страница 46: ...ces refer to Appendix E Medical Device Specifications and Peripheral Medical Devices If you exchange a patient s monitor the new monitor will consider the patient s peripheral devices as new It is recommended that you send a test packet following patient change Taking the patient s vitals Before you take the patient s first set of vitals make sure the patient knows how to use each piece of equipme...

Страница 47: ...he position of the patient s arm can significantly affect the readings In general the arm should rest supported below the level of the heart A consistent position should be used for each reading to increase the accuracy of the data While taking blood pressure the monitor displays the real time cuff inflation pressure in the Systolic display When the reading is complete the monitor displays systoli...

Страница 48: ...Genesis DM Clinician Guide 1 Hold the cuff so that the artery marker white arrow points away from you 2 With our palm facing upwards slip your hand through the cuff 3 Position the cuff so that the artery marker arrows point to your ring finger and slide the cuff up your arm over your elbow There should be about a two finger space between the crease in your elbow and the cuff 4 Grasp the tab and pu...

Страница 49: ... instruct patients to remove their information from the screen before they leave the monitor Patient initiated Monitoring Sessions Patients can send vitals to their health care provider at any time they do not have to wait for a scheduled report time Patients can initiate unscheduled monitoring sessions by pressing the blue RETEST key The Genesis DM monitor prompts patients through the monitoring ...

Страница 50: ... without transmitting the data to LifeStream Technicians also use Manual mode when they calibrate the monitor When in Manual mode the monitor only collects vitals It does not prompt display text or collect test results from peripheral devices The results are not transmitted To enter or exit Manual mode press the MANUAL button ...

Страница 51: ...DO NOT disassemble DO NOT autoclave ethylene oxide sterilize or immerse in water or other liquid DO NOT spray any cleaners on or into the unit UNPLUG before cleaning disinfecting or performing any maintenance For service call Honeywell HomMed Customer Service Clean only the surfaces of the monitor and the accessories Qualified service technicians must perform any cleaning servicing or repairs that...

Страница 52: ...ed equipment unplug the unit and notify Customer Service If a monitor has been dropped or damaged call Customer Service Qualified service personnel must inspect any dropped or damaged units before they are assigned for use Calibration verification Honeywell HomMed recommends that you establish and routinely follow a calibration schedule for all measurement devices If equipment appears to be out of...

Страница 53: ...ation while the cuff is attached to a patient could cause bruising or other injury DO NOT verify NIBP calibration while the cuff is attached to a patient To verify the NIBP cuff s calibration 1 Secure the blood pressure cuff to a rigid fixture about the size of an arm 2 Tee in a standard calibrated mercury or digital manometer with the NIBP cuff 3 Press START YES to enter the monitor s Setup Mode ...

Страница 54: ... oximeter tester Refer to the manufacturer s manual for testing procedures For information about ordering testers contact Customer Service Remote Upgrades Following each successful Vitals transmission the home unit will check the upgrade server once per day to identify any available upgrades When available the unit will attempt to download the new software between 1 00 A M and 3 00 A M local time ...

Страница 55: ...rogramming instructions in this section assume that you understand basic programming concepts such as how to enter Setup Mode use the monitor keys for programming and navigate through the menu options If you do not know how to perform these tasks please review the information in Section 3 Programming the Genesis DM Monitor ECG Glucose Meters Oximetry Peak Flow Meters Prothrombin Meters Temporal Te...

Страница 56: ...lect ECG data you must assign a COM port If you do not assign a COM port the monitor will not prompt for the device and it will not collect data from that device even if the device is connected to the COM port It is also important to use an isolated port Isolated ports protect patients from any potential of shock when they use a device that is connected to the monitor The following instructions as...

Страница 57: ...ically turns off after five minutes When connected to the Genesis DM monitor the monitor turns the device off after a successful transmission The monitor erases the reading prior to turning the device off If the patient uses the device as a stand alone not connecting it to the monitor the device erases the old reading when the patient turns it on Please see the manufactures instructions for approv...

Страница 58: ... finger also works well Relax and breathe normally Do not move or talk during the recording After the initial prompt informing the patient that it is time to take an ECG the Genesis DM monitor prompts the patient through the following steps 1 Apply two to three drops of the electrode solution on both electrodes of the ECG device Be careful to drop liquid onto the electrode rather than touch the bo...

Страница 59: ...noise the patient should still transmit the reading The ecg home does not have an OFF button The device automatically turns off after five minutes When connected to the Genesis DM monitor the monitor turns the device off after a successful transmission The monitor erases the reading prior to turning the device off If the patient uses the device as a stand alone not connecting it to the monitor the...

Страница 60: ...e and date If any reading is missing a time and date stamp the monitor will not collect it The monitor does not erase any data from the glucose meter and does not collect or transmit control solution test results obtained in test mode or designated as control results If you want to erase data from LifeScan or Roche Accu Chek models you can purchase software and a customized cable from LifeScan or ...

Страница 61: ...t the appropriate glucose meter 3 In the Glucometer menu assign either COM1 COM 2 or COM A whichever is appropriate for cable 4 In the Glucometer Time menu set the collection frequency 5 Exit Setup Mode Attaching the glucose connector cable One end of the connector cable has a 4 or 6 PIN connector that plugs into the com port on the rear of the monitor The other end of the cable either has a jack ...

Страница 62: ... of the glucose meter differs from meter to meter The following table explains important differences between glucose monitors The following table contains important notes specific to glucose meter types Meter Turn on to transmit Glucose meter text display during transmission LifeScan One Touch Basic LifeScan One Touch Profile Yes Code Insert strip LifeScan One Touch Ultra No PC Bayer Ascensia Elit...

Страница 63: ...ompt it will also prompt the patient to make sure that the cable is connected to the com port programmed for the device The monitor repeats both prompts 1 Complete all tests and place the device next to the connector cable before the monitoring session Make sure the glucose meter is off 2 Genesis DM prompts Please attach the glucose meter to the monitor Be sure that the cable is attached to COM 1 ...

Страница 64: ...te programming instructions In addition to the monitor the oximeter can also be assigned via the Quick Setup Wizard available when the monitor is first turned on 1 In Setup Mode scroll to the Option Menu and press RETEST to enter the menu 2 Scroll to Oximeter and press RETEST 3 Using either the YES or NO key scroll to the correct COM port COM1 or COM2 and press RETEST 4 In the Oximeter Time menu s...

Страница 65: ...site of the arm wearing the blood pressure cuff Point out the raised finger design on the top of the oximeter and explain that the finger sensor is worn with the design on the top of the finger Honeywell HomMed recommends using the middle finger to make it easier for the patient to press monitor keys However when necessary the patient may use a different digit Instruct the patient to insert the mi...

Страница 66: ... your values by adding 1 5 To do this multiply the PEF FEV1 by 1 015 Assigning a COM port You must assign a COM port to the peak flow meter or the monitor will not prompt the patient for data or communicate with the device to collect data even if the device is connected to the COM port Assigning a COM port triggers the monitor to do the following Include peak flow meter prompts during the monitori...

Страница 67: ...tion and moves on to the next device If the Genesis DM has collected all data from all devices the monitor concludes the monitoring session Once the Genesis DM establishes communication with the peak flow meter Genesis DM displays and says Receiving data please wait Data upload is finished The Genesis DM monitor does not display peak flow meter test results For a complete list of prompts refer to ...

Страница 68: ...ched to the Genesis DM monitor could possibly result in receiving an electrical shock DO NOT attempt to take PT INR readings with a prothrombin time meter when it is connected to the Genesis DM monitor Disconnect the prothrombin time meter before use Always follow the manufacturer s instructions for proper use Instruct the patient to never use their prothrombin meter when it is attached to the Gen...

Страница 69: ...er next to the monitor before the monitoring session The monitor does not prompt or allow time for the patient to take a test during the monitoring session because the time required for prothrombin testing is too long When the monitor prompts the patient to attach the device the patient has a few minutes to turn their device on navigate to the Print Send menu and transmit the latest test result On...

Страница 70: ...the Main Menu 4 Select SHOW RESULTS and press 5 Go to PRINT SEND DATA and press 6 Go to THIS RESULT and press to transmit If the latest reading collected by the prothrombin time meter was an error reading the Genesis DM monitor collects the error reading inserting zeros for values A common prothrombin time meter error is Error 81 which occurs when there was an insufficient amount of blood for accu...

Страница 71: ...dles the last reading received into the data packet Assigning a COM port You must assign a COM port to the scanner or the monitor will not prompt the patient for data or communicate with the device to collect data even if the device is connected to the COM port Assigning a COM port triggers the monitor to include temperature prompts during the monitoring session and to communicate with the scanner...

Страница 72: ...for temporal temperature The monitor prompts for temperature after collecting blood pressure as follows It is now time to take your temperature Cue text Time to take your temperature Please take your temperature as instructed Cue text Take temperature as instructed The patient may skip collecting temperature by pressing the NO key after the temperature prompt Patient Instructions If appropriate re...

Страница 73: ... than usual 06 Do you need your clinician to contact you today 07 Are you out of any of your medications 08 Are you having difficulty taking any of your medications 09 Are you having difficulty following your diet 10 Are you having any nausea today 11 Are you having trouble controlling your blood sugar 12 Are you having any pain 13 Have you been having any chest pain 14 Are you having any headache...

Страница 74: ...e in your baby s movement today 37 Have you had any blurred vision today 38 Have there been any changes in the medication you are taking 39 Are you having difficulty following your weight loss plan 40 Are you having difficulty following your exercise plan 41 Do you feel more anxious or upset today 42 Has your mood been more depressed this week compared to a normal week 43 Are you having difficulty...

Страница 75: ...ptly Contact your health care provider if you are having difficulty taking your medications or have questions 55 Are you having trouble controlling your blood sugar same as Question Number 11 Blood sugar control may be affected by diet weight medications physical activity illnesses and infections Uncontrolled blood sugar over time may lead to medical complications If you have taken your medication...

Страница 76: ...injure yourself Reminders Number Reminders 101 You have an appointment with your doctor today Please write down any questions you may have and bring them to your appointment 102 You have an appointment with your doctor this week Please write down any questions you may have and bring them to your appointment 103 You have an appointment with your health care provider today Please write down any ques...

Страница 77: ...legs elevated while sitting 115 Please remember to eat foods low in Sodium 116 Please remember to wear your oxygen as prescribed 117 Please remember to use your nebulizer as prescribed 118 Please remember to do your exercises as prescribed 119 Please remember to take your pain medications as needed and as prescribed ...

Страница 78: ...han talking 4 Can others hear your snoring in another room 5 Has your snoring ever bothered other people 6 Has anyone noticed that you quit breathing nearly every day during your sleep 7 Has anyone noticed that you quit breathing during sleep 3 4 times a week 8 Do you feel tired or fatigued today after your sleep 9 Do you feel tired fatigued or not up to par during your wake time nearly every day ...

Страница 79: ...e the blood pressure cuff on your right arm above the elbow Tighten it securely Place the finger sensor on the middle finger of your left hand with the finger design facing up Rest your arm as instructed by your clinician Press the green start key Please remove the blood pressure cuff Please remove the finger sensor and the blood pressure cuff It is now time to take your temperature Please take yo...

Страница 80: ...on the two electrodes to take an ECG reading Press the yes key when you are finished Please attach the ECG device to the monitor No ECG device detected Please make sure the cable is attached to the port marked COM A 1 2 on the back of the monitor Receiving data please wait Data upload is finished Please remember to take your medications as prescribed by your physician and maintain the proper diet ...

Страница 81: ...e Scale 3001004B1 Duplex Jack 6030002B1 Finger Sensor 3005000B1 Finger Sensor Extension 3001106B1 Glucose meter cable Bayer 3001100B1 Glucose meter cable LifeScan 5991006B1 Glucose meter cable Roche Roche cable 3001111B1 Glucose Prestige adapter cable HomMed cable 3001108B1 Glucose Roche adapter cable HomMed cable 3004004B1 ID card 3001006B1 Inline Coupler 3001007B1 Modular Adapter 3000010B1 NIBP ...

Страница 82: ...Bayer Ascensia Elite XL Ascensia Breeze Ascensia Breeze2 Ascensia Contour Roche Accu Chek Advantage ACCU CHEK Aviva ACCU CHEK Compact Plus Home Diagnostics Inc Prestige IQ TrueTrack Smart System Peak flow meters Ferraris Piko 1 Peak Flow Meter Prothrombin meters ITC Hemosense ProTime Microcoagulation System InRatio Temporal temperature Exergen Temporal Scanner Specifications Refer to manufacturer ...

Страница 83: ...ive Blood Pressure Manufacturer SunTech Method of measurement Oscillometric Blood pressure range 20 to 260 mmHg 40 260 mmHg systolic 20 200 mmHg diastolic Pressure Transducer Accuracy 3 mmHg between 0 mmHg and 300 mmHg for operating conditions between 0 C and 50 C and less than 95 relative humidity Patient safety Maximum cuff inflation time is limited to 50 seconds Duration of blood pressure readi...

Страница 84: ...eater Update Rate 0 5 seconds Stability of Calibration Zero calibration is performed at power up Multipoint span factory calibration is preserved through power cycles Factory calibration is good for 5 years of normal use Appendix F Electromagnetic Guidances Guidance and Manufacturer s Declaration Electromagnetic Emissions The Genesis DM is intended for use in the electromagnetic environment specif...

Страница 85: ...ge IEC 61000 4 5 1 kV line s to line s 2 kV line s to earth 1 kV line s to line s 2 kV line s to earth Mains power quality should be that of a typical commercial or hospital environment Voltage Dips Short Interruptions and Voltage Variations on Power Supply Input Lines IEC 61000 4 11 5 UT 95 dip in UT for 0 5 cycle 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip in UT for 25 cycles 5 UT 95 dip in UT ...

Страница 86: ...ance in meters m Field strengths from fixed RF transmitters as determine by an electromagnetic site survey a should be less than the compliance level in each frequency rangeb Interference may occur in the vicinity of equipment marked with the following symbol NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic prop...

Страница 87: ...to Frequency of Transmitter m Rated Maximum Output Power of Transmitter W 150 kHz to 80 MHz d 1 17 P 80 MHz to 800 MHz d 1 17 P 800 MHz to 2 5 GHz d 2 33 P 0 01 0 12 0 12 0 23 0 1 0 37 0 37 0 74 1 1 17 1 17 2 33 10 3 70 3 70 7 37 100 11 70 11 70 13 30 For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be estimated using the equat...

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