VitalPoint® HOME Patient User Manual
Contents
1. 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 USEOF THIS DEVICE ISCONTRAINDICATED IN APPLICATIONS REQUIRING AUTOMATED ARRHYTHMIA DETECTION e THIS DEVICE IS 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 VA DL 00035 Rev 6 DL 00035 Rev 6 el 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 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 identify2. 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 1O o1 00035 Rev e 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 that 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 If 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 Ifthe 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 prob
3. 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 6 DL 00035 Rev 7 be highlighted Press all answers that apply and press Continue to move on Operati Ng the VitalPoint Home Monitor 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 ee Which of the following pain problems would you like to report Please select all that apply ES ime In other cases you may select more than one answer Each button you press will Chest Headache SELECTING OPTIONS E Uu Legs Feet Hands The VitalPoint Home Monitor operates by displaying options on the screen A voice prompt also reads each option aci ei cg To select an option simply press the button on the screen with your finger Some screens allow for only one response for example yes or no questions MAIN MENU SCREEN The Main Menu displays a personal greeting and lets you know if there are activities to do right away Do you have any vision changes such as blurred vision or any numbness or tingling Hello Jane Dow Yes You Gave actyities to do now Begin Achtse As soon as you select your answer the monitor moves on to the next screen To begin activities press Begin Activities and follow the
4. 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 monitor 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 MEDICATION REMINDER D aU 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 Make sure your bladder is e
5. this battery for up to 5 hours If power is out for a longer period of time contact your clinician DL 00035 Rev 6 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 the confirmation message is displayed itis 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
6. CH COULD CAUSE LIMB DAMAGE INTHE EVENT THE CUFF NEEDS TOBE 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 CUT TING THE HOSE OFF OF THE CONNECTOR 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 APULSE 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 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 ORIN HARM TO THE PATIENT AND MAY VOID WARRANTY COVERAGE TO AVOID AN ELECTRICAL SHOCK HAZARD THE CONDUCTIVE PART OF THEELECTRODES SHOULD NOT BE ALLOWED TO COME IN CONTACT WITH OTHER CONDUCTIVE OBJECTS INCLUDING EARTH DO NOT INTRODUCE ANY ADDITIONAL PATIENT CONNECTION THAT MAY PRODUCE ELECTRICAL CURRENT VITALPOINT APPLIES APPROXIMATELY 2 MICROAMPERES 2 pA ACCESSORIES SHOULD BE DISPOSED OF ACCORDING TO THE MANUFACTURE
7. EN 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 their customer information suggest ing the customer use a surge arrestor Tel
8. 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 measurement 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 p
9. IVE BLOOD PRESSURE CUFF ON THE SAME LIMB AS THE SpO SENSOR DURING BLOOD PRESSURE MEASUREMENTS THE PERFUSION IS TEMPORARILY REDUCED WHICH CAN RESULT ININACCURATE PULSE OXIMETRY READINGS e DO NOT ALLOW THE NON INVASIVE BLOOD PRESSURE CUFF OR HOSE TO COME IN CONTACT WITH FLUIDS IF THIS 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 6 Xi Re 6 XI PRECAUTION e TOOBTAINACCURATE BLOOD PRESSURE READINGS KEEP THE 13 ECG RESPIRATION PRECAUTIONS PRECAUTION LIMB AND THE CUFF AS STILL AS POSSIBLE e LINE ISOLATION MONITOR TRANSIENTS MAY RESEMBLE ACTUAL NON INVASIVE BLOOD PRESSURE MEASUREMENTS MAY NOT CARDIAC WAVEFORMS AND THUS INHIBIT HEART RATE ALARMS BE ACCURATE IF THE PATIENT IS CONVULSIVE EXPERIENCING TO AVOID THE RISK OF THIS HAPPENING FOLLOW THE DIRECTIONS TREMORS ORIS DEFIBRILLA TED DURING THE MEASUREMENT FOR PROPER ELECTRODE PLACEMENTS AND KEEP THE ECG LEAD 10 PULSE OXIMETRY PRECAUTIONS WIRES AWAY FROM SOURCES OF LINE NOISE e READ INSTRUCTIONS PROVIDED WITH THE PULSE OXIMETRY e TOAVOID LARGE OFFSET POTENTIALS DUE TO POLARIZATION OF SENSOR TO UNDERSTAND THE BEST APPLICATION TECHNIQUE ELECTRODES BE SURE TO USE ONLY ELECTRODE TYPES SPECIFIED AND ALL RELEVANT SAFETY INFORMATION FOR THIS DEVICE AND BE SURE THAT AL
10. It is recommended that the healthcare facility ensures that patients complete all necessary paperwork so that the facility complies with the HIPAArequirements 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 CJPS Medical Systems VitalPoint Home Monitor is a label that contains among other information a product identifier in the format US AAAEQHITXXXX 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 I DL 00035 Rev 6 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 AAAEQHHTXXXX The digits represented by are the REN without a decimal point i e O3 is a R
11. L ELECTRODES USED ARE e DO NOT APPLY THE PULSE OXIMETRY SENSOR ON THE SAME LIMB OF THE SAME TYPE AS THENON INVASIVE BLOOD PRESSURE CUFF DURING BLOOD 14 FOLLOW THE MANUFACTURER S INSTRUCTIONS FOR USE WHEN PRESSURE MEASUREMENTS THE PERFUSION IS TEMPORARILY USINGAGLUCOSE METER AND STRIPS REDUCED WHICH CAN RESULT IN INACCURATE PULSE OXIMETRY 15 FOLLOW THE MANUFACTURER S INSTRUCTIONS FOR USE WHEN READINGS USING A FLUID STATUS MONITOR e BRIGHT LIGHT CAN CREATE PROBLEMS WITH THE PULSE OXIMETRY 16 FOLLOW THE MANUFACTURER S INSTRUCTIONS FOR USE WHEN MEASUREMENTS RESULTING IN INACCURATE PULSE OXIMETRY USING A PROTHROMBIN TIME METER READINGS IF THE SENSOR IS IN A PLACE WHERE IT MAY BE EXPOSED TOBRIGHTLIGHT COVER THE SENSORWITH SOME OPAQUE MATERIAL TO BLOCK THE LIGHT e PULSEOXIMETRY 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 11 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 12 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 O
12. NL Y X I DL 00035 Rev 6 DL 00035 Rev 5 XIII Content Classification eee iV Explanation of Packaging and Labeling Symbols V Intended Use ieee vi Contraindications Overview i i i i it vi General Information LL LL viii Warnings and Precautions LL Ln ix Warnings Overview JU 0 LLL ix Precautions Overview LLL xi Introduction eee 1 Monitor Features and Controls 2 Before You Get Started v oe ol 4 Choosing a Location forthe Monitor 4 Turning the Monitor On 4 Power Supply ln 4 Phone Connection 5 Monitor Setup 5 5 9 9 9 lh 5 Important Reminders OU 6 For Help i i i i i i i 7 Operating the VitalPoint Home Monitor 8 Selecting Options LL 8 Main Menu Screen 9 Reporting Symptoms 11 Taking Measurements 13 Measuring Blood Pressure 14 Measuring Pulse Oximetry 15 Measuring Temperature 15 Measuring Blood Glucose 16 MeasuringProthrombinTime 16 Measuring Fluid Status 17 Measuring Weight ss sss sso 18 MeasuringECG LLL 18 Medication Reminder 19 Viewing Nurse s Instructions i 20 Viewing Setup Options 21 Concluding Activities J 23 Trademarks o oO 25 Disclaimer 25 X IV DL 00035 Rev 6 P USA V DOS CJPS Introduction Di Thank you for using the Vi
13. Pistes LL memet at ESI S cal system S Medica onitor cu eds ome Patient Guide Hello Jane Doe You have activities to do O in 3 hours 28 minutes R eport Symptoms Take Measurements See Nurse s Instructions Monitoring Ps Vitalpoi System C JPS VitalPolnt Manufactured by CJPS Medical Systems Scottsdale Arizona USA Paris France Tel 1 480 939 4362 www cjps medicalsystems com 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 CJPS Medical Systems CJPS 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 CJPS 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 CJPS Medical Systems product be sure to read carefully and understand all manuals provided with the product CJPS Medical Systems Remote Device Connectivity complies with the U S Health Insurance Portability and Accountability Act HIPAA protecting the security and privacy of health data
14. R S INSTRUCTIONS ON PACKAGING PRECAUTIONS OVERVIEW PRECAUTION 1 U S FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN THE VITALPOINT HOME MONITOR IS NOT INTENDED TO BE A PRIMARY SOURCE OF MEDICAL INFORMATION CONTACT CLINICIAN WITH QUESTIONS FOR CONTINUED OPERATION ALWAYS CONNECT THE MONITOR TOA WALL OUTLET FAILURE TO DO THIS CAN LEAD TO AN INTERRUPTION OF MONITORING THERE ARE NO USER SERVICEABLE PARTS IN THIS DEVICE 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 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 THE VITALPOINT HOME MONITOR SHOULD NOT BE USED ADJACENT TOOR STACKED WITH OTHER EQUIPMENT AND THAT IF ADJACENT OR STACKED USE IS NECESSARY THE VITALPOINT HOME MONITOR SHOULD BE OBSERVED TO VERIFY NORMAL OPERATION THESE CHEMICALS MAY DAMAGE THE MONITOR S FRONT PANEL ACETALDEHYDE ACETONE AMMONIA BENZENE HYDROXYTOLUENE METHYLENE CHLORIDE OR OZONE DO NOT USE THOSE CHEMICALS OR CLEANSERS CONTAINING N ALKYLDIMETHYLBENZYLAMMONIUM CHLORIDE NON INVASIVE BLOOD PRESSURE PRECAUTIONS e DO NOT APPLY THE NON INVAS
15. TO THE RECEPTACLES 9 DONOTUSEAMONITOR 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 TODEVICES THAT ARENOT 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 pP Rev 6 IX WARNING X DL 00035 Rev 6 10 1 12 13 14 e IN 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 A MEASUREMENT A BLOCKED ORKINKED HOSE COULD LEAD TOEXCESSIVE PRESSUREIN THE BLOOD PRESSURE CUFF WHI
16. 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 Loos 5 o 5 IMPORTANT REMINDERS FOR HELP Do not use a monitor or any accessory that shows any sign of damage 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 Use only approved accessories with the monitor health nurse pharmacist or physician with respect to your ongoing care e he monitor is intended for indoor use only The monitor should not be This patient guide will assist you with basic operation of the VitalPoint Home exposed to liquids Monitor Your clinician can make other necessary adjustments such as volume control if necessary e Contact your clinician immediately if the device stops working or you can no ne hear sounds when actu SS are due WARNING e The monitor should be left on at all times You should always be able to see the screen If not con
17. ed 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 take a blood pressure measurement able 1 Sit down in a chair next to the monitor 2 Roll up the sleeve on your arm or remove any tight clothing Use left arm if 3 Slide the cuff onto your arm 4 Make sure that the bottom edge of the cuff is 1 2 5 cm above the crease of your elbow 5 Make sure that the tubing is on the inside of your elbow 6 Secure the cuff by using the Velcro strap to make the cuff snug but not too tight 7 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 WARNING BE SURE THE NON
18. ephone 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 oL ooossRev 6 did Rev 6 IH ees eS Oa e Classification Explanation of Packaging and Labelin This equipment is ETL listed es For indoor use only This equipment is classified as N Caution consult accompanying documents e Class ll e Type CF month year Manufacture date mm yyyy Continuous operation Do not use if package damaged S Direct current power input 15 V 600 milliamperes SN Serial number Catalog number R U S federal law restricts this device to sale by or only cate on the order of a physician ON On OFF Off O Oo Class device tt This end up y Fragile breakable ES Atmospheric pressure limitation 0 3 bar to 1 0 bar Storage temperature limitation 4 F to 122 F 20 C to 50 C os Humidity limitation 1096 to 9596 IPXO Ordinary protection LZ Type CF DL 00035 Rev 6 5 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 Intended Use 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 ad
19. g when lit Catalog CAUTION For Product amp uppqirt Call 11248 593 5926 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 11 2005 decision for you If you feel you need to visit your doctor or go to the Emergency SN In Room you should do so Again you should not depend on VitalPoint to make that Tl Il I li I l ll A decision for you Also VitalPoint Home is not intended to be the primary source of P1011 information You must follow your clinicians advice regarding home care and REF office visits Refer to the printed information that you received from your clinician R Connect only CIPS Medical Systems approved components See operating instructions DM 01000421 USE LJ Patent Pending Made in USA Fluid status monitor receptacle 1 Glucose meter receptacle 2 Weight scale receptacle 3 Pulse oximeter receptacle SpOz Blood pressure receptacle NBP ECG Electrocardiogram receptacle ECG v Temperature probe receptacle TEMP Fluid status monitor receptacle 1 4 E F Me Glucose meter receptacle 2 2 Q Weight scale receptacle 3 3 a 2 e Power receptacle POWER I USB port for CJPS approved accessorie
20. instructions on the screen 8 EDT Rev 6 DL 00035 Rev 6 9 Or if activities are scheduled for later REPORTING SYMPTOMS When you press Report Symptoms the monitor will remind you this is not an Hello Jane Doe emergency response system You have activities to do in SHOUTS lt 2 minutas If you feel the problem you are reporting is an emergency or requires you to call your Report Symptoms Take Measurements nurse your doctor or 911 please do so See Nurse s Instructions Please do not rely on the monitor to make this decision for you These activities are programmed by your clinician for your care These activities can include Taking measurements Press Continue to report symptoms e Medication reminders Nurse s instructions may include nurse s questions and predefined answers The monitor allows you to report symptoms related to e Breathing It is very important that you complete all activities when requested e Swelling e Heart The Main Menu screen includes options to e Stomach bowel e Report symptoms e Urine e Take measurements Wound e See nurse s instructions e Pain e Adjust speaker volume or dial Central Server e General To report symptoms press Report Symptoms and follow the instructions on For each problem you choose to report the monitor will display a series of the screen questions Answer each to move on to the next screen To take measurements press Take Measurements
21. lems 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 measure e Blood pressure e Pulse oximetry e Temperature e Prothrombintime e Fluid status e Blood glucose e 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 finish
22. mpty 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 Information about medication dose frequency and any instructions for taking the prepared to take your weight medication will be displayed on the monitor You will be asked if you took your brace Continue medication 4 Step on the platform and remain as still as possible without leaning TECNONN edication aspirin on anything Dose 162 mg 1 tab s orally When ready press Take Measurement When finished the measurement will ia ie conan be displayed on the screen in both pounds and kilograms EEE PEO A E E E A T prescription or non prescription medication If you receive any error codes while taking measurements follow the instructions Have you taken your medication on the screen and contact your clinician Measuring ECG Only a clinician or a patient authorized by their clinician is authorized to perform an e f you answer Yes the monitor will advance to the next activity ECG measurement The measurement will report automatically on the monitor 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 am out of my medication am ha
23. 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 Trademarks CJPS VitalPoint is a trademark of CJPS Medical Systems All other trademarks are the property of their respective owners Disclaimer The information in this document has been carefully examined and is believed to be reliable Furthermore CJPS Medical Systems reserves the right to make changes to any products herein to improve readability function or design CJPS 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 MEDICAL SYSTEMS CJPS CJPS Medical Systems Scottsdale Arizona USA Paris France Tel 1 480 939 4362 E mail Inquiries Q CJPS MedicalSystems com www CJPS MedicalSytems com VitalPoint is a trademark of CJPS Medical Systems All other trademarks are the property of their respective owners 2010 CJPS Medical Systems LLC All rights reserved DL 00035 Rev 6
24. s only Reserved for future use Phone jack receptacle PHone ee 4 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 foottraftic 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 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
25. send the data to your clinician While doing so it displays E j Ht 9 Loudest Sending Data Now Go Back i This may take a few minutes Please do not use your telephone while the data is sent Press Go Back if you would like to return to the Main Menu Press Continue if you would like to adjust the alarm volume Set Alarm Volume 1 Quietest l 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 E E j Et 10 Loudest Go Back NR 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 upload data immediately 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
26. tact your clinician right away THE VITALPOINT HOME MONITOR IS NOT AN EMERGENCY RESPONSE SYSTEM THE DEVICE LABELING ADVISES PATIENTS TO CONTACT THEIR CAREGIVER NURSE OR DOCTOR e It 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 CALL LOCAL EMERGENCY NUMBER AS APPROPRIATE OR the monitor to avoid mistakes in your medical record GO TO THE EMERGENCY ROOM WHENEVER THEY FEEL e Discuss all medications with your physician THE NEED TO DO SO THE VITALPOINT HOME MONITOR DOES NOT ANALYZE PATIENT INFORMATION NOR DOES e f any of the following occurs contact your clinician immediately IT OFFER MEDICAL ADVICE Activities do not appear or patient name is no longer on the main screen Data is no longer displayed screen is not functioning If you have questions about this information or about the safe operation of the Data on the screen is no longer heard speaker is not functioning monitor or do not understand any of the instructions on the screen call your Data cannot be input touch screen not functioning clinician right away Device does not start up or does not function 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
27. talPoint Home Monitor The monitor allows your clinician 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 andtemperature and canbe 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 WARNING 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 NUMBERAS APPROPRIATE OR GO TO THE EMERGENCY ROOM WHENEVER THEY FEEL THENEED TODOSO THE VITALPOINT HOME MONITOR DOES NOT ANALYZE PATIENT INFORMATION NOR DOES IT OFFER MEDICAL ADVICE 2 DL 00035 Rev 6 Monitor Features and Controls o S NN NN NN NN b Home Monitoring System CIPS vitairoint Main screen Power e onm D L E oO Service access CIPS ss L CAUTION Do not H remove for qualified ser vice personnel Phone jack Reserved for future P wer on indicator LED on when lit Battery charging indica tor LED power connected and battery Serial number chargin
28. these items when they occur in the text they are shown using the following typographical conventions WARNING 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 6 Warnings and Precautions Nt CJPS lll WARNINGS OVERVIEW CRITICAL EXPLOSION HAZARD DO NOT USE IN THE PRESENCE OF FLAMMABLE ANESTHETICS DO NOT INCINERATE UNIT WARNING 1 PACEMAKER PATIENTS RATE METERS MAY CONTINUE TO COUNT THE PACEMAKER RATE DURING OCCURRENCES OF CARDIAC ARREST ORSOME 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 ROOMWHENEVER THEY FEEL THENEED TO DO SO THEVITALPOINT HOME MONITOR DOES NOT ANALYZE PATIENT INFORMATION NOR DOES IT OFFER MEDICAL ADVICE 3 DONOTUSETHE MONITOR NEAR SOURCES OF LIQUIDS SUCH AS SINKS SHOWERS OR BATHTUBS 4 UNPLUG THE MONITOR BEFORE CLEANING DO NOT SPRAY CLEANERS IN
29. ult operator The VitalPoint Home Monitor is not intended for use on neonatal patients 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 activities whereby medical data vital signs symptoms and medication compliance is Version collected The system is intended to transfer the collected data to a remote Please refer to this patient guide for instructions on warnings precautions and site where it is stored and reviewed by a clinician The system is also intended additional information Printed dnd S 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 e Blood glucose level e Oxygen saturation e Fluid status e Pulse rate e Prothrombintime e Temperature e Electrocardiogram ECG and heart e Weight rate monitors WARNING THE VITALPOINT HOME MONITOR IS NOT AN EMERGENCY RESPONSE
30. ut 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 Glucose 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
31. ving 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 VIEWING SETUP OPTIONS To change the speaker volume or initiate a connection with the Central Server press Setup on the Main Menu Your clinician will be informed Hello Jane Doe You have activities to do in 3 hours 28 minutes Report Symptoms Take Measurements See Nurse s Instructions Press Continue to advance to the next activity if one is scheduled The monitor will return to the Main Menu if no additional activities are scheduled VIEWING NURSE S INSTRUCTIONS Toadjustthe speaker volume press Setup When the next screen is displayed Nurse s instructions are available through the Main Menu Nurse s instructions press Set Speaker Volume may also be displayed after all other activities are completed What would you like to do Press Main Menu to return to the Main Menu Set Speaker Volume Dial Central Server Now 1 Press the appropriate button depending on whether you want to increase or LM decrease the current volume which is highlighted in yellow of the voice prompt t Concluding Activities a Set Voice Prompt Volume J d When all activities for a session are complete or you have completed taking measurements or have reported symptoms the monitor will
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