Delphi DL-00035 User's Manual
Contents
1. FOR HELP Your clinician should have gone over the basic use of the monitor with you Also refer to any printed or written information you received from your home health nurse pharmacist or physician with respect to your ongoing care This patient guide will assist you with basic operation of the VitalPoint Home Monitor Your clinician can make other necessary adjustments such as volume control if necessary THE VITALPOINT HOME MONITOR IS NOT AN EMERGENCY RESPONSE SYSTEM THE DEVICE LABELING ADVISES PATIENTS TO CONTACT THEIR CAREGIVER NURSE OR DOCTOR CALL LOCAL EMERGENCY NUMBER AS APPROPRIATE OR GO TO THE EMERGENCY ROOM WHENEVER THEY FEEL THE NEED TO DO SO THE VITALPOINT HOME MONITOR DOES NOT ANALYZE PATIENT INFORMATION NOR DOES IT OFFER MEDICAL ADVICE If you have questions about this information or about the safe operation of the monitor or do not understand any of the instructions on the screen call your clinician right away DL 00035 Rev 4 7 m Operating the VitalPoint Home Monitor O IMPORTANT The monitor should remain on at all times Please work with your clinician to set the volume at a comfortable level for the voice and alert prompts SELECTING OPTIONS The VitalPoint Home Monitor operates by displaying options on the screen A voice prompt also reads each option To select an option simply press the button on the screen with your finger Some screens allow for only one response for example2. USING A GLUCOSE METER AND STRIPS 15 FOLLOW THE MANUFACTURER S INSTRUCTIONS FOR USE WHEN USING A FLUID STATUS MONITOR 16 FOLLOW THE MANUFACTURER S INSTRUCTIONS FOR USE WHEN USING A PROTHROMBIN TIME METER DL 00035 Rev 4 XIII Classification iv Explanation of Packaging and Labeling Symbols V CCO V vi Contraindications OVEIVISW cs LLL UT Sua bt HO TERREA vi General Information eese or det leto tete e a A viii Warnings and PECAS RENE IX Warnings ba ia IX Precautions esse ettet ttbi ER EE eee p Ue ebbe xi eja 1 Monitor Features and Controls secet ettet edi aa adea br 2 FS OMS VOUS Reg em 4 Choosing a Location for the Monitor 4 Turning the Monitor 4 Dimming Feature 4 Power _ 4 Phone Comecei sse tete ette erret pte pee tea 5 Monitor SetuD 5 Important Reminders 6 Si PS Ms 7 Operating the VitalPoint Home Monitor 8 Selecting da od entire NS aaa ela 8 Main Menu 5 9 Reporting SYMPTOMS 11 Taking Measurements REDIERE I ette EU nce cedes 13 Measuring Blood Pressure sees 14 Measuring Pulse OxiImetry_ scettr 15 Measuring Temper
3. A MEASUREMENT A BLOCKED OR KINKED HOSE COULD LEAD TO EXCESSIVE PRESSURE IN THE BLOOD PRESSURE CUFF WHICH COULD CAUSE LIMB DAMAGE IN THE EVENT THE CUFF NEEDS TO BE STOPPED DURING OPERATION DUE TO AN ERROR CREATED BY A BLOCKED OR KINKED HOSE THE CUFF SHOULD BE REMOVED FROM THE ARM BY RELEASING THE VELCRO STRAP OR PULLING CUTTING THE HOSE OFF OF THE CONNECTOR 10 PULSE OXIMETRY WARNINGS REPOSITION THE PULSE OXIMETRY SENSOR AT LEAST EVERY 4 HOURS 2 HOURS FOR POORLY PERFUSED PATIENTS MOVE THE SENSOR IF YOU SEE ANY SIGNS OF SKIN IRRITATION OR IMPAIRED CIRCULATION ELEVATED LEVELS OF CARBOXYHEMOGLOBIN OR METHEMOGLOBIN IN MONITORED PATIENTS CAN RESULT IN INACCURATE PULSE OXIMETRY READINGS PULSE OXIMETER SHOULD BE CONSIDERED AS AN EARLY WARNING DEVICE AS A TREND TOWARD PATIENT DEOXYGENATION IS INDICATED BLOOD SAMPLES SHOULD BE ANALYZED BY A LABORATORY CO OXIMETER 11 PROBES AND CABLES ARE DESIGNED FOR USE WITH SPECIFIC MONITORS VERIFY COMPATIBILITY AND USE ONLY APPROVED ACCESSORIES WITH VITALPOINT USING NON APPROVED ACCESSORIES MAY RESULT IN DEGRADED PERFORMANCE DAMAGE TO THE MONITORING EQUIPMENT OR IN HARM TO THE PATIENT AND MAY VOID WARRANTY COVERAGE 12 TO AVOID AN ELECTRICAL SHOCK HAZARD THE CONDUCTIVE PART OF THE ELECTRODES SHOULD NOT BE ALLOWED TO COME IN CONTACT WITH OTHER CONDUCTIVE OBJECTS INCLUDING EARTH 13 DO NOT INTRODUCE ANY ADDITIONAL PATIENT CONNECTION THAT MAY PRODUCE ELECTRICAL CURRENT V
4. INFORMATION NOR DOES IT OFFER MEDICAL ADVICE DL 00035 Rev 4 1 2 DL 00035 Rev 4 onitor Features and Controls gt DELPHI VitalPoint Main screen dims after 5 minutes Battery charging indica tor LED power connected and battery charging Power switch when lit Battery VITALPOINT HOME MONITORING SYSTEM IS NOT INTENDED AS AN EMERGENCY Charging RESPONSE SYSTEM If you ever feel that you need to call your nurse your doctor or 911 you should do so You should not depend on VitalPoint Home to make that decision for you If you feel you need to visit your doctor or go to the Emergency Home Monitoring System Power on indicator LED on when lit Serial number Catalog number CAUTION For Product Pupobrt Call 111888 526 1426 CH 1 2005 Room you should do o Ki you hou no depend on Voe to matter S AN decision for you Also VitalPoint Home is not intended to be the primary source of REF 1011 information You must follow your clinicians advice regarding home care and office visits Refer to the printed Information that you received from your clinician Service access Medical Systems Connect only Delphi Medical Systems approved components See operating instructions DM 01000421 gne T4 Patent Pending Medein USA CAUTION Do not remove for qualified ser vice personnel only EX Phone jack r
5. NOT TO BE USED AS AN APNEA MONITOR e THIS DEVICE IS NOT TO BE USED IN AN MRI ENVIRONMENT e THIS DEVICE IS NOT TO BE USED IN AN OPERATING ROOM OR SURGICAL ENVIRONMENT V DL 00035 Rev 4 The VitalPoint Home Monitor can also be configured to remind the patient to take medications at certain times of the day as well as to take requested vital signs measurements The VitalPoint Home Monitor is set up for a specific patient s needs by a clinician While the VitalPoint Home Monitor is intended for use in adult and pediat ric patients the user interface is tailored for an adult operator The VitalPoint Home Monitor is not intended for use on neonatal patients Version Please refer to this patient guide for instructions on warnings precautions and additional information Printed in U S A DL 00035 Rev 4 VII 1 gm Hom Monito Syster General Information This user manual provides information for users of the VitalPoint Home Monitor For the sake of brevity the terms VitalPoint monitor or device are sometimes used in this document to refer to the VitalPoint Home Monitor IMPORTANT Users should read this entire patient guide before operating the VitalPoint Home Monitor Failure to do so could result in personal injury and or death If you have questions about the information in this patient guide or about the safe operation of this system contact your clinician TYPOGRAPHICAL CONVENTIONS
6. DO NOT USE THOSE CHEMICALS OR CLEANSERS CONTAINING N ALKYLDIMETHYLBENZYLAMMONIUM 9 NON NVASIVE BLOOD PRESSURE PRECAUTIONS e DO NOT APPLY THE NON INVASIVE BLOOD PRESSURE CUFF ON THE SAME LIMB AS THE SpO SENSOR DURING BLOOD PRESSURE MEASUREMENTS THE PERFUSION IS TEMPORARILY REDUCED WHICH CAN RESULT IN INACCURATE PULSE OXIMETRY READINGS e DO NOT ALLOW THE NON INVASIVE BLOOD PRESSURE CUFF OR TO COME IN CONTACT WIth FEUIDSaIF Tals OCCURS ALLOW TO DRY THOROUGHLY BEFORE USE CHECK THE HOSE AND CUFF FREQUENTLY FOR SIGNS OF DAMAGE OR DEBRIS AN OBSTRUCTION IN THE HOSE MAY INTERFERE WITH INFLATION AND DEFLATION RESULTING IN INACCURATE NON INVASIVE BLOOD PRESSURE READINGS DL 00035 Rev 4 XI PRECAUTION XI 01 00035 Rev 4 10 11 12 e TO OBTAIN ACCURATE BLOOD PRESSURE READINGS KEEP THE LIMB AND THE CUFF AS STILL AS POSSIBLE NON INVASIVE BLOOD PRESSURE MEASUREMENTS MAY NOT BE ACCURATE IF THE PATIENT IS CONVULSIVE EXPERIENCING TREMORS OR 15 DEFIBRILLATED DURING THE MEASUREMENT PULSE OXIMETRY PRECAUTIONS e READ INSTRUCTIONS PROVIDED WITH THE PULSE OXIMETRY SENSOR TO UNDERSTAND THE BEST APPLICATION TECHNIQUE AND ALL RELEVANT SAFETY INFORMATION e DO NOT APPLY THE PULSE OXIMETRY SENSOR ON THE SAME LIMB AS THE NON INVASIVE BLOOD PRESSURE CUFF DURING BLOOD PRESSURE MEASUREMENTS THE PERFUSION IS TEMPORARILY REDUCED WHICH CAN RESULT IN INACCURATE PULSE OXIMETRY READINGS e BRIGHT LIGHT CAN CREATE P
7. IN THIS USER MANUAL This guide contains warnings precautions and notes to help call your atten tion to the most important safety and operational aspects of the system To help identify these items when they occur in the text they are shown using the following typographical conventions STATEMENTS THAT DESCRIBE SERIOUS ADVERSE REACTIONS AND POTENTIAL SAFETY HAZARDS PRECAUTION STATEMENTS THAT CALL ATTENTION TO INFORMATION REGARDING ANY SPECIAL CARE TO BE EXERCISED BY THE PRACTITIONER AND OR PATIENT FOR THE SAFE AND EFFECTIVE USE OF THE DEVICE IMPORTANT Statements that call attention to additional significant information about the device or a procedure Note Statements that provide supplemental information VIII DL 00035 Rev 4 Warnings and Precautions CoS DELPHI r WARNINGS OVERVIEW CRITICAL EXPLOSION HAZARD DO NOT USE IN THE PRESENCE OF FLAMMABLE ANESTHETICS DO NOT INCINERATE UNIT 1 PACEMAKER PATIENTS RATE METERS MAY CONTINUE TO COUNT THE PACEMAKER RATE DURING OCCURRENCES OF CARDIAC ARREST OR SOME ARRHYTHMIAS DO NOT RELY ENTIRELY UPON RATE METER ALARMS 2 THE VITALPOINT HOME MONITOR IS NOT AN EMERGENCY RESPONSE SYSTEM THE DEVICE LABELING ADVISES PATIENTS TO CONTACT THEIR CAREGIVER NURSE OR DOCTOR CALL LOCAL EMERGENCY NUMBER AS APPROPRIATE OR GO TO THE EMERGENCY ROOM WHENEVER THEY FEEL THE NEED TO DO SO THE VITALPOINT HOME MONITOR DOES NOT ANALYZE PATIENT INFORMATION NOR DOES IT OFFER
8. ITALPOINT APPLIES APPROXIMATELY 2 MICROAMPERES 2 pA 14 ACCESSORIES SHOULD BE DISPOSED OF ACCORDING TO THE MANUFACTURER S INSTRUCTIONS ON PACKAGING 01 00035 Rev 4 PRECAUTIONS OVERVIEW PRECAUTION 1 U S FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN 2 THE VITALPOINT HOME MONITOR IS NOT INTENDED TO BE A PRIMARY SOURCE OF MEDICAL INFORMATION CONTACT CLINICIAN WITH QUESTIONS 3 FOR CONTINUED OPERATION ALWAYS CONNECT THE MONITOR TO A WALL OUTLET FAILURE TO DO THIS CAN LEAD TO AN INTERRUPTION OF MONITORING 4 THERE ARE NO USER SERVICEABLE PARTS IN THIS DEVICE 5 PORTABLE AND MOBILE RADIO FREQUENCY RF COMMUNICATIONS EQUIPMENT CAN AFFECT THE VITALPOINT HOME MONITOR IF THE VITALPOINT HOME MONITOR DOES NOT APPEAR TO BE WORKING NORMALLY TRY TO RELOCATE OR REORIENT THE VITALPOINT HOME MONITOR 6 USE OF ACCESSORIES NOT APPROVED FOR USE WITH THE VITALPOINT HOME MONITOR MAY RESULT IN INCREASED EMISSIONS OR DECREASED IMMUNITY OF THE VITALPOINT HOME MONITOR REFER TO THE APPROVED ACCESSORIES LIST FOR THE VITALPOINT HOME MONITOR 7 THE VITALPOINT HOME MONITOR SHOULD NOT BE USED ADJACENT TO OR STACKED WITH OTHER EQUIPMENT AND THAT IF ADJACENT OR STACKED USE IS NECESSARY THE VITALPOINT HOME MONITOR SHOULD BE OBSERVED TO VERIFY NORMAL OPERATION 8 THESE CHEMICALS MAY DAMAGE THE MONITOR S FRONT PANEL ACETALDEHYDE ACETONE AMMONIA BENZENE HYDROXYTOLUENE METHYLENE CHLORIDE OR OZONE
9. MEDICAL ADVICE 3 DO NOT USE THE MONITOR NEAR SOURCES OF LIQUIDS SUCH AS SINKS SHOWERS OR BATHTUBS 4 UNPLUG THE MONITOR BEFORE CLEANING DO NOT SPRAY CLEANERS INTO THE RECEPTACLES 5 DO NOT USE A MONITOR OR ANY ACCESSORY THAT SHOWS ANY SIGN OF DAMAGE 6 DO NOT USE THE MONITOR IF THE MAIN MENU SCREEN IS NOT DISPLAYED PROPERLY WHILE CONNECTED TO AC POWER 7 DEVICE INTERCONNECTIONS THROUGH ITS OMD OTHER MEDICAL DEVICE PORT THE VITALPOINT HOME MONITOR CAN BE CONNECTED TO EXTERNAL DEVICES THE MONITOR SHOULD NOT BE CONNECTED TO DEVICES THAT ARE NOT DESCRIBED IN THIS MANUAL 8 THE VITALPOINT HOME MONITOR CONTAINS A LITHIUM ION BATTERY ONLY TRAINED SERVICE PERSONNEL SHOULD REMOVE OR CHANGE THE BATTERY 9 NON INVASIVE BLOOD PRESSURE WARNINGS THE NON INVASIVE BLOOD PRESSURE NBP CUFF SHOULD BE AT THE SAME LEVEL AS THE PATIENT S HEART IF THE NBP CUFF CANNOT BE PLACED AT THIS LEVEL ADD TO MEASURED PRESSURE VALUES 1 4 mmHg FOR EACH 2 cm ABOVE HEART LEVEL OR SUBTRACT 1 4 mmHg FOR EACH 2 cm BELOW HEART LEVEL DL 00035 Rev 4 IX SOME CASES FREQUENT AND PROLONGED MEASUREMENTS CAN RESULT IN PETECHIA ISCHEMIA PURPURA OR NEUROPATHY CHECK THE CUFF SITE REGULARLY WHEN TAKING FREQUENT MEASUREMENTS OVER AN EXTENDED TIME PERIOD ALSO CHECK FOR ANY SIGNS OF RESTRICTED CIRCULATION IN THE EXTREMITIES OF THE LIMB WHERE THE NBP CUFF IS WRAPPED e BE SURE THE NON INVASIVE BLOOD PRESSURE HOSE IS NOT BLOCKED OR KINKED DURING
10. ROBLEMS WITH THE PULSE OXIMETRY MEASUREMENTS RESULTING IN INACCURATE PULSE OXIMETRY READINGS IF THE SENSOR IS IN A PLACE WHERE IT MAY BE EXPOSED TO BRIGHT LIGHT COVER THE SENSOR WITH SOME OPAQUE MATERIAL TO BLOCK THE LIGHT e PULSE OXIMETRY READINGS MAY BE INACCURATE IN THE PRESENCE OF TOO MUCH MOTION OR IF THE PATIENT HAS TREMORS IF QUESTIONABLE READINGS ARE OBTAINED RE CHECK THE VITAL SIGNS BY ALTERNATE MEANS BEFORE TAKING MEDICATION SHOULD THE AC ADAPTER S GREEN LIGHT NOT REMAIN ON WHILE PLUGGED INTO AN AC OUTLET REPORT THE PROBLEM TO YOUR CLINICIAN AND DISCONTINUE MONITOR USE UNTIL THE PROBLEM CAN BE IDENTIFIED AND CORRECTED YOU SHOULD NOT RELY SOLELY ON THE MONITOR REGARDING WHEN TO TAKE MEDICATIONS YOU SHOULD CONSULT YOUR PHYSICIAN BEFORE TAKING ANY PRESCRIPTION OR NON PRESCRIPTION MEDICATION OR CHANGING ANY MEDICATION REGIMENS VITALPOINT IS INTENDED AS A REMINDER SYSTEM ONLY PRECAUTION 13 ECG RESPIRATION PRECAUTIONS e LINE ISOLATION MONITOR TRANSIENTS MAY RESEMBLE ACTUAL CARDIAC WAVEFORMS AND THUS INHIBIT HEART RATE ALARMS TO AVOID THE RISK OF THIS HAPPENING FOLLOW THE DIRECTIONS FOR PROPER ELECTRODE PLACEMENTS AND KEEP THE ECG LEAD WIRES AWAY FROM SOURCES OF LINE NOISE e TO AVOID LARGE OFFSET POTENTIALS DUE TO POLARIZATION OF ELECIRODES ABE SURE T iUSE ONE ELECTRODE RES SPECIFIED FOR THIS DEVICE AND BE SURE THAT ALL ELECTRODES USED ARE OF THE SAME TYPE 14 FOLLOW THE MANUFACTURER S INSTRUCTIONS FOR USE WHEN
11. activity if one is scheduled The monitor will return to the Main Menu if no additional activities are scheduled VIEWING NURSE S INSTRUCTIONS Nurse s instructions are available through the Main Menu Nurse s instructions may also be displayed after all other activities are completed Press Main Menu to return to the Main Menu VIEWING SETUP OPTIONS To change the speaker volume or initiate a connection with the Central Server press Setup on the Main Menu Hello Jane Doe 3 hours 28 minutes See Nurse s Instructions You have activities to do in Report Symptoms Take Measurements To adjust the speaker volume press Setup When the next screen is displayed press Set Speaker Volume Set Speaker Volume Dial Central Server Now What would you like to do Press the appropriate button depending on whether you want to increase or decrease the current volume which is highlighted in yellow of the voice prompt 9 p M Set Voice Prompt Volume 0 Off E E j Ek 9 Loudest Press Go Back if you would like to return to the Main Menu Press Continue if you would like to adjust the alarm volume Go Back LL Set Alarm Volume 1 Quietest HE p bt 10 Loudest To initiate a connection with the Central Server from the setup menu press Dial Central Server Now This allows you to test the connection or upl
12. ake a blood pressure measurement 1 2 able 3 4 Sit down in a chair next to the monitor Roll up the sleeve on your arm or remove any tight clothing Use left arm if Slide the cuff onto your arm Make sure that the bottom edge of the cuff is 1 2 5 cm above the crease of your elbow Make sure that the tubing is on the inside of your elbow Secure the cuff by using the Velcro strap to make the cuff snug but not too tight Place your arm raised to the level of your heart on a table Remain still and do not talk while your blood pressure is being taken When ready press Take Measurement and remain still until the measurement is complete When finished the measurement will be displayed on the screen If you receive any error codes while taking measurements follow the instructions on the screen and contact your clinician BE SURE THE NON INVASIVE BLOOD PRESSURE HOSE IS NOT BLOCKED OR KINKED DURING A MEASUREMENT A BLOCKED OR KINKED HOSE COULD LEAD TO EXCESSIVE PRESSURE IN THE BLOOD PRESSURE CUFF WHICH COULD CAUSE LIMB DAMAGE IN THE EVENT THE CUFF NEEDS TO BE STOPPED DURING OPERATION DUE TO AN ERROR CREATED BY A BLOCKED OR KINKED HOSE THE CUFF SHOULD BE REMOVED FROM THE ARM BY RELEASING THE VELCRO STRAP OR PULLING CUTTING THE HOSE OFF OF THE CONNECTOR Measuring Pulse Oximetry The monitor will display the following instructions to apply the pulse oximetry sensor and take a pulse oximetry measu
13. asure e Blood pressure e Pulse oximetry e Temperature Prothrombin time Fluid status Blood glucose Weight e ECG For each selection the monitor will display detailed instructions on how to take each measurement You should be familiar with the operation and use of the vital signs accessories attached to your monitor If you have difficulty or if the monitor displays an error message call your clinician When all instructions have been read press Take Measurement A voice prompt will alert you to Please remain still measurement may take some time After the measurement is complete the measurement results will be displayed on the screen After each measurement you will be asked if you have more measurements to do Answer Yes or No If you answer Yes the monitor will continue to store measurements in memory and send them to your clinician all at once when you are finished Press No if you are finished the data will be sent to your clinician If you accidentally press No the monitor will immediately send this information to your clinician Once it is finished sending the data you can continue taking more measurements using the Take Measurements button on the Main Menu When measurements appear as an activity after completion of the measurements the screen will advance to the next scheduled activity Measuring Blood Pressure The monitor will display the following instructions to apply the cuff and t
14. ature esset teer tc SEU een 15 Measuring Blood GIUCOSS n 16 Measuring Prothrombin Tite 16 Measuring Fluid Status 17 Measuring Weight seasons br teret pere 18 Measuring ECG sss 18 Medication Reminder to trn eb oe tuc 19 Viewing Nurse s InstructionS_ o PG 20 Viewing Setup 21 Concluding CIT 23 Tadema c 25 Disclaimer 25 XIV 01 00035 Rev 4 Introduction peer VitalPoint Thank you for using the VitalPoint Home Monitor The monitor allows your clini cian to monitor your status while you are at home or in another healthcare facil ity The monitor collects vital signs and other information from you and sends it to your clinician over a phone line It can check your blood pressure oxygen saturation pulse rate respiration rate ECG and temperature and can be connected to devices such as a digital weight scale prothrombin time meter fluid status monitor and a blood glucose meter Your clinician can also use the monitor to send you messages reminding you to conduct certain tests or take your medication THE VITALPOINT HOME MONITOR IS NOT AN EMERGENCY RESPONSE SYSTEM THE DEVICE LABELING ADVISES PATIENTS TO CONTACT THEIR CAREGIVER NURSE OR DOCTOR CALL LOCAL EMERGENCY NUMBER AS APPROPRIATE OR GO TO THE EMERGENCY ROOM WHENEVER THEY FEEL THE NEED TO DO SO THE VITALPOINT HOME MONITOR DOES NOT ANALYZE PATIENT
15. eceptacle Reserved for future use Fluid status monitor receptacle 1 Glucose meter receptacle 2 Weight scale receptacle 3 Pulse oximeter receptacle SpO Blood pressure receptacle NBP Electrocardiogram receptacle ECG END Temperature probe receptacle TEMP 1 z Fluid status monitor receptacle 1 2 E UE Glucose meter receptacle 2 Us E Weight scale receptacle 3 O Power receptacle POWER _ USB port for Delphi approved accessories only Reserved for future use moe Phone jack receptacle DL 00035Rev 4 3 BEFORE YOU GET STARTED Some important things to note before using the VitalPoint Home Monitor Choosing a Location for the Monitor Work with your clinician to identify a convenient location for the monitor The VitalPoint Home Monitor should be placed in a location that is e Near a power outlet and a phone Jack e Flat and stable A tabletop is a good choice e Away from common areas Avoid areas with a lot of foot traffic to help prevent injury from tripping on cords and to help prevent the cords from being disconnected e Away from a water source Avoid areas near sinks showers and bathtubs Turning the Monitor On Turn the monitor on by flipping the switch located on the back of the monitor A green light on the front is lit when the monitor is powered on The monitor should be left on at all times while in your home Dimming Feature The monitor
16. eir customer information suggest ing the customer use a surge arrestor Telephone companies report that electrical surges typically lightning transients are very destructive to customer terminal equipment connected to AC power sources This has been identified as a major nationwide problem DL 00035 Rev 4 IHI D 1 lassification ia This equipment is ETL listed This equipment is classified as e Class ll e Type CF e IPXO e Continuous operation Explanation of Packaging and Label E For indoor use only N Caution consult accompanying documents m month year Manufacture date mm yyyy Do not use if package damaged is ux Direct current power input 15 V 600 milliamperes SN Serial number REF Catalog number R U S federal law restricts this device to sale by or only on the order of a physician ON On OFF Off Class device This end up v Fragile breakable Atmospheric pressure limitation 0 3 bar 1 0 bar Storage temperature limitation A F to 122 F 20 C to 50 C Humidity limitation 1096 to 9596 IPXO Ordinary protection v Type CF DL 00035 Rev 4 nS Intended Use The VitalPoint Home Monitor is intended to be used as a clinical tool for remotely monitoring a patient s health status at home or in another healthcare facility The system is intended to guide patients through a set of scheduled acti
17. erem VitalPoint VitalPoint is a trademark of Delphi Corporation All other trademarks are the property of their respective owners The information in this document has been carefully examined and is believed to be reliable Furthermore Delphi Medical Systems reserves the right to make changes to any products herein to improve readability function or design Delphi Medical Systems does not assume any liability arising out of the application or use of any product or circuit described herein neither does it cover any license under its patent rights nor the rights of others DL 00035 Rev 4 25 VITALPOINT MONITOR DE SINAIS VITAIS Importado por Delphi Automotive Systems do Brasil Ltda CNPJ 00 857 758 0001 40 Av Goi s 1820 1860 Santa Paula S o Caetano do Sul SP Fone 55 11 4234 9500 e mail delphi delphi com br website www delphi com br Fabricado por Delphi Medical Systems 5725 Delphi Drive Troy Michigan 48098 2815 U S A Fone 1 888 526 1426 e mail medical delphi com www delphi com medical Respons vel T cnico Ricardo Augusto Martins CREA n 5060652270 N do Registro na ANVISA 80455010001 DELPHI Delphi Medical Systems 5725 Delphi Drive Troy Michigan 48098 2815 U S A www delphi com medical VitalPoint is a trademark of Delphi Corporation All other trademarks are the property of their respective owners 2009 Delphi Corporation All rights reserved DL 00035 Rev 4
18. hat time the monitor will ask you if there are more problems to report e f you have more answer Yes you will be returned to the Choose a Problem to Report screen e f you are finished answer No you will be taken to the Confirm Problems screen At the Confirm Problems screen the monitor will display all the problems you have reported for example Breathing e f the reported problems are correct press Yes send the problems to my clinician now to send the report to your clinician e f the reported problems are correct but you have additional measurements to take press Yes but would like to record measurement s to go to the Take Measurements screen All data will be sent when sending measurements e f the reported problems are incorrect press No would like to report more problems to return to the Choose a Problem to Report screen You have already reported problems for this category Would you like to change what you have reported If you select a problem that has already been reported the monitor will warn you e f you press Yes any problems you reported in this category before will be deleted and replaced with your new answers e f you press No the monitor will first ask if you have more problems to report before returning to the Confirm Problems screen TAKING MEASUREMENTS When Take Measurements is pressed from the Main Menu the monitor will allow you to me
19. he confirmation message is displayed it is OK to use your phone again If the phone line is busy while the monitor is trying to send data or telephone connection to the server is interrupted for some reason the following message will appear on the monitor The Monitor could not communicate with the Central Server You will be returned to the Main Menu Monitor will keep trying to dial the Central Server every five minutes Data will be stored until successful communication is complete IMPORTANT If you attempt to use your phone while the monitor is uploading data you will not hear a dial tone If you need to use your phone immediately e g to call local emergency number in an emergency turn off the monitor and try your phone again No data will be lost Monitor Setup The monitor will be programmed by your clinician for your care Confirm that your name appears on the monitor when it is installed in your home and that you fully understand its use If you have any questions regarding the monitor contact your clinician Alert chimes will sound when it is time to perform a scheduled activity The chime will continue to sound every 5 minutes until the activity is completed If you do not complete the activity the monitor will send a message to your clinician that the activity has been missed DL 00035 Rev 4 5 IMPORTANT REMINDERS e Do not use a monitor or any accessory that shows any sign of damage e Use only approved acces
20. its represented by are the REN without a decimal point 1 03 is a REN of 0 3 For earlier products the REN is separately shown on the label If this VitalPoint Home Monitor causes harm to the telephone network the telephone company will notify you in advance that temporary discontinuance of service may be required But if advance notice isn t practical the telephone compa ny will notify the customer as soon as possible Also you will be advised of your right to file a complaint with the FCC if you believe it s necessary The telephone company may make changes in its facilities equipment operations or procedures that could affect the operation of the VitalPoint Home Monitor If this happens the telephone company will provide advance notice in order for you to make necessary modifications to maintain uninterrupted service Connection to party line service is subject to state tariffs U S Contact the state public utility commission public service commission or corporation commission for information If installed in a home with specially wired alarm equipment connected to the telephone line ensure the installation of the VitalPoint Home Monitor does not disable the alarm equipment If you have questions about what will disable alarm equipment consult the telephone company or qualified installer Electrical safety advisory Parties responsible for equipment requiring AC power should consider including an advisory notice in th
21. ity Act HIPAA protecting the security and privacy of health data It is recommended that the healthcare facility ensures that patients complete all necessary paperwork so that the facility complies with the HIPAA requirements This equipment complies with Part 68 of the U S Federal Communications Commission FCC rules and the requirements adopted by the American Council for Terminal Attachments ACTA On the back of the Delphi Medical Systems VitalPoint Home Monitor is a label that contains among other information a product identifier in the format US AAAEO TXXxXxX If requested this number must be provided to the telephone company The Universal Services Ordering Code USOC jack used to connect the VitalPoint Home Monitor to the premises wiring and telephone network must comply with the applicable FCC Part 68 rules and requirements adopted by the ACTA l DL 00035 Rev 4 The ringer equivalence number REN is used to determine the number of devices that may be connected to a telephone line Excessive RENs on a telephone line may result in the devices not ringing in response to an incoming call In most but not all areas the sum of RENs should not exceed five 5 To be certain of the number of devices that may be connected to a line as determined by the total RENS contact the local telephone company For products approved after July 23 2002 the REN is part of the product identifier that has the format US AAAEO TXXXX The dig
22. lucose Meter that came with the monitor or if you want to enter your blood glucose level manually To use the OneTouch Ultra meter connect the meter to the appropriate cable on the monitor and follow the instructions on the screen For manually entered information the monitor will ask you to verify that the number you entered is correct Blood glucose level can be entered in either mg dL or mmol L depending on personal preference or meter type If you receive any error codes while taking measurements follow the instructions on the screen and contact your clinician Measuring Prothrombin Time PRECAUTION FOLLOW THE MANUFACTURER S INSTRUCTIONS FOR USE WHEN USING A PROTHROMBIN TIME METER 1 Press Take Measurements 2 Press Protime The monitor will display the following instructions 1 Enter your protime reading as displayed on your meter per manufacturer s instructions 2 Is this PT prothrombin time or INR internationalized normalized ratio 3 Press Complete when data is entered If you receive any error codes while taking measurements follow the instructions on the monitor s screen and contact your clinician Measuring Fluid Status PRECAUTION FOLLOW THE MANUFACTURER S INSTRUCTIONS FOR USE WHEN USING A FLUID STATUS MONITOR To use the fluid status monitor connect the monitor to receptacle 1 on the back of the VitalPoint monitor and follow the instructions on the screen The VitalPoint m
23. nician or a patient authorized by their clinician is authorized to perform an ECG measurement The measurement will report automatically on the monitor MEDICATION REMINDER PRECAUTION YOU SHOULD NOT RELY SOLELY ON THE MONITOR REGARDING WHEN TO TAKE YOUR MEDICATIONS YOU SHOULD CONSULT YOUR PHYSICIAN BEFORE TAKING ANY PRESCRIPTION OR NON PRESCRIPTION MEDICATION OR CHANGING ANY MEDICATION REGIMENS VITALPOINT IS INTENDED AS A REMINDER SYSTEM ONLY Information about medication dose frequency and any instructions for taking the medication will be displayed on the monitor You will be asked if you took your medication Medication aspirin Dose 162 mg 1 tab s orally Frequency once a day Consult with a physician before taking any prescription or non prescription medication Have you taken your medication e f you answer Yes the monitor will advance to the next activity if there is one The monitor will return to the Main Menu if no additional activities are scheduled e f you answer No the monitor will ask you why you did not take your medication Please specify the reason for not taking the medication out of my medication am having difficulty taking my medication don t want to take the medication right now The monitor will alert you that your clinician will be informed of the problem Your clinician will be informed Press Continue to advance to the next
24. oad data immediately Concluding Activities perh VitalPoint When all activities for a session are complete or you have completed taking measurements or have reported symptoms the monitor will send the data to your clinician While doing so it displays Sending Data Now This may take a few minutes Please do not use your telephone while the data is sent Do not use your phone until the monitor indicates Confirmation Monitor successfully communicated with the Central Server IMPORTANT If you attempt to use your phone while the monitor is uploading data you will not hear a dial tone If you need to use your phone immediately e g to call local emergency number in an emergency turn off the monitor and try your phone again No data will be lost If the phone line is in use or there is an issue with the phone connection the monitor will display The Monitor could not communicate with Central Server You will be returned to the Main Menu Monitor will keep trying to dial Central Server about every five minutes The monitor will continue to try to dial the Central Server until communication is successful If communication is not successful you will receive a final message Monitor has not been able to communicate with the Central Server for a long time Please contact your clinician for help Contact your clinician right away Home Monitoring System Trademarks p
25. onitor will display the following instructions to take a fluid status measurement 1 Snap the new electrodes to the cable 2 Place the first electrode just above the top of your breastbone with the arrow pointing down 3 Place the second electrode just below the bottom of your breastbone with the arrow pointing up 4 Press the Start button on the fluid status machine 5 Remain still and do not talk while your fluid status is taken The measurement may take some time The VitalPoint monitor will record and display the data displayed on the fluid status monitor Measuring Weight Position the scale close to the monitor The monitor will display the following instructions to take a weight measurement 1 Make sure you are wearing no clothing or similar light clothing and your shoes are removed 2 Make sure your bladder is empty 3 Do not step onto the scale yet It is very important that there is no weight on the scale when the weight sequence is started This allows the scale to re zero itself and become prepared to take your weight Press Continue 4 Step on the platform and remain as still as possible without leaning on anything When ready press Take Measurement When finished the measurement will be displayed on the screen in both pounds and kilograms If you receive any error codes while taking measurements follow the instructions on the screen and contact your clinician Measuring ECG Only a cli
26. pa torn 9 nt a ta IPoin tems I dical Sys hi Me onitor VitalPoim Home M Patient Guid Hello Jane Doe You have activities to do O in S hours 28 Minutes Report Symptoms Take Measurements See Nurse s Instructions Monitoring System Fu VitalPoint ca LP YStems De Medical 5 VitalPoint D s Medical System Manufactured by Delphi Medical Systems 5725 Delphi Drive Troy Michigan 48098 2815 U S A The information in this document is subject to change without notice This document contains proprietary information that is protected by copyright No part of this document may be reproduced in any manner in whole or in part except for brief excerpts in reviews and scientific papers without the prior written consent of Delphi Medical Systems Delphi Medical Systems makes no warranty of any kind on this material includ ing but not limited to the implied warranties of merchantability and fitness for a particular purpose Delphi Medical Systems shall not be liable for errors con tained herein or for incidental or consequential damages concerning the furnishing performance or use of this material Before using any Delphi Medical Systems product be sure to read carefully and understand all manuals provided with the product Delphi Medical Systems Remote Device Connectivity complies with the U S Health Insurance Portability and Accountabil
27. rement 1 Place the finger sensor on your middle or index finger If the blood pressure cuff is also in use do not apply the finger sensor and blood pressure cuff to the same arm 2 Fit the sensor as shown on the screen When ready press Take Measurement and remain still until the measurement is complete When finished the measurement will be displayed on the screen If you receive any error codes while taking measurements follow the instructions on the screen and contact your clinician Measuring Temperature The monitor will display the following instructions to use the temperature probe and take a temperature reading 1 Put the tip into a new disposable plastic cover if one is available If you do not have a plastic cover clean the pointed end probe with soap and warm water or rubbing alcohol Rinse it with cool water 2 With your mouth open put the covered tip under your tongue 3 Close your lips gently around the temperature probe When ready press Take Measurement and remain still until the measurement is complete When finished the measurement will be displayed on the screen If you receive any error codes while taking measurements follow the instructions on the screen and contact your clinician Measuring Blood Glucose PRECAUTION FOLLOW THE MANUFACTURER S INSTRUCTIONS FOR USE WHEN USING A GLUCOSE METER AND STRIPS The monitor will ask you if you wish to use the LifeScan OneTouch Ultra Blood G
28. s main screen will automatically dim after 5 minutes so that the brightness will not disturb a patient who wishes to sleep A simple tap on the screen or any monitor activity will return the screen to its original brightness Power Supply The monitor should be kept plugged into an AC power outlet at all times while in your home Connect the AC adapter to the monitor by plugging the round connector into the receptacle on the right side of the monitor Plug the other end of the AC adapter into an AC power outlet The green light on the plug indi cates proper connection of the adapter Use only the power supply cord that came with the monitor The monitor contains a lithium ion rechargeable battery In the event of a power outage the monitor can function on this battery for up to 5 hours If power is out for a longer period of time contact your clinician 4 DL 00035 Rev 4 Phone Connection The monitor should remain connected to a phone line at all times Connect the phone line by plugging one end into the receptacle on the right hand side of the monitor and the other into a wall phone jack The monitor will need to use the phone line for brief periods during the day to send any reported data to your clinician While dialing the following message will appear on the monitor Sending Data Now This may take a few minutes Please do not use your telephone while the data is sent Do not use the phone while the monitor is communicating Once t
29. sories with the monitor e The monitor is intended for indoor use only The monitor should not be exposed to liquids e Contact your clinician immediately if the device stops working or you can no longer hear sounds when activities are due e The monitor should be left on at all times You should always be able to see the screen If not contact your clinician right away e t is important to enter the correct information at all times to ensure your vital signs are being accurately reported to your clinician e The monitor is here to record your data DO NOT allow anyone else to use the monitor to avoid mistakes in your medical record e Discuss all medications with your physician e f any of the following occurs contact your clinician immediately Activities do not appear or patient name is no longer on the main screen Data is no longer displayed screen is not functioning Data on the screen is no longer heard speaker is not functioning Data cannot be input touch screen not functioning Device does not start up or does not function e Never attempt to repair a malfunctioning monitor All repairs should be conducted by trained service personnel Contact your clinician immediately if the monitor needs service e Accessories such as glucose meter and strips blood pressure cuffs temperature probes ECG cables and SpO sensors should be disposed of according to manufacturer s instructions on packaging 6 DL 00035 Rev 4
30. vities whereby medical data vital signs symptoms and medication compliance is collected The system is intended to transfer the collected data to a remote site where it is stored and reviewed by a clinician The system is also intended to allow the clinician to modify the patient s scheduled activities in response to the collected medical data or other information available to the clinician The intent is to provide clinicians caring for patients outside the hospital with a means for keeping track of how the patients are doing without the patients having to come in for a checkup or requiring the clinician to go to the patients It provides periodic remote monitoring of the patients self reported symptoms or vital signs including e Non invasive blood pressure Blood glucose level e Oxygen saturation e Fluid status Pulse rate e Prothrombin time e Temperature Electrocardiogram ECG and heart Weight rate monitors THE VITALPOINT HOME MONITOR IS NOT AN EMERGENCY RESPONSE SYSTEM THE DEVICE LABELING ADVISES PATIENTS TO CONTACT THEIR CAREGIVER NURSE OR DOCTOR CALL LOCAL EMERGENCY NUMBER AS APPROPRIATE OR GO TO THE EMERGENCY ROOM WHENEVER THEY FEEL THE NEED TO DO SO THE VITALPOINT HOME MONITOR DOES NOT ANALYZE PATIENT INFORMATION NOR DOES IT OFFER MEDICAL ADVICE CONTRAINDICATIONS OVERVIEW CONTRAINDICATION e USE OF THIS DEVICE IS CONTRAINDICATED IN APPLICATIONS REQUIRING AUTOMATED ARRHYTHMIA DETECTION THIS DEVICE IS
31. vities when requested The Main Menu screen includes options to e Report symptoms e Take measurements e See nurse s instructions e Adjust speaker volume or dial Central Server To report symptoms press Report Symptoms and follow the instructions on the screen To take measurements press Take Measurements and follow the instructions on the screen To check the nurse s instructions press See Nurse s Instructions and follow the instructions on the screen Note This option will not exist if nurse s instructions have not been entered To adjust speaker volume or dial Central Server now press Setup on the Main Menu REPORTING SYMPTOMS When you press Report Symptoms the monitor will remind you this is not an emergency response system If you feel the problem you are reporting is an emergency or requires you to call your nurse your doctor or 911 please do so Please do not rely on the monitor to make this decision for you Press Continue to report symptoms The monitor allows you to report symptoms related to e Breathing e Swelling e Heart Stomach bowel e Urine e Wound e Pain e General For each problem you choose to report the monitor will display a series of questions Answer each to move on to the next screen Sub problems in only one problem category can be reported at a time but you will be able to report additional problems when the current problem category is com plete At t
32. yes or no questions Do you have any vision changes such as blurred vision or any numbness or tingling As soon as you select your answer the monitor moves on to the next screen 8 DL 00035 Rev 4 In other cases you may select more than one answer Each button you press will be highlighted Press all answers that apply and press Continue to move on Note At any time you may press Go Back to review the previous menu screen or Main Menu to return to the Main Menu screen Which of the following pain problems would you like to report Please select all that apply Chest Headache Legs Feet Hands HU Stomach MAIN MENU SCREEN The Main Menu displays a personal greeting and lets you know if there are activities to do right away Hello Jane Doe You have activities to do now Begin Activities To begin activities press Begin Activities and follow the instructions on the screen DL 00035Rev 4 9 Or if activities are scheduled for later Hello Jane Doe You have activities to do in 3 hours 28 minutes Report Symptoms Take Measurements See Nurse s Instructions These activities are programmed by your clinician for your care These activities can include e Taking measurements e Medication reminders e Nurse s instructions may include nurse s questions and predefined answers It is very important that you complete all acti
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