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Philips M3812A Instructions For Use Manual

Home hub,telestation, standard scale, steady scale, blood pressure unit, rhythm strip recorder,pulse oximeter.
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   Summary of Contents for Philips M3812A

  • Page 2 Published by Philips Medical Systems, a division of Philips Electronics Information North America Corporation. Philips Medical Systems reserves the right to make changes to both this Instructions for Use and to the product it describes. Product specifications are subject to change without notice. Nothing contained within this Instructions for Use is intended as any offer, warranty, promise or contractual condition, and must not be taken as such.
  • Page 3 Notice Printing New editions of this document will incorporate all material updated since History the previous edition. Update packages may be issued between editions and contain replacement and additional pages to be merged by a revision date at the bottom of the page. Note that pages which are rearranged due to changes on a previous page are not considered revised.
  • Page 4 Notice...
  • Page 5: Table Of Contents

    Philips Telemonitoring Services System........1-2...
  • Page 6 Pulse Oximeter ........... 2-11 Pulse Oximeter Display Case .
  • Page 7 4. Troubleshooting ......... . 4-1 Overview .
  • Page 8 Contents 4...
  • Page 9: Introduction

    It also shows you how to maintain the devices so that they will continue to take true readings. Thank You! Thank you for taking an active role in your home healthcare plan. Philips and your healthcare provider applaud your efforts to actively participate in you health care plan.
  • Page 10: Philips Telemonitoring Services System

    Philips Telemonitoring Services System Philips Telemonitoring Services System Your Philips Telemonitoring Services system includes a set of measurement devices known as the Patient Telemonitoring Set. Each device takes an important measurement -- such as weight, blood pressure and pulse, heart rhythm, %SpO -- and then wirelessly sends that measurement to the Home Hub or TeleStation.
  • Page 11: Safety And Precautions

    He or she will tell you when and how often to take your vital signs. Please read all of the instructions in this guide before using the Philips Telemonitoring System and follow the instructions carefully.
  • Page 12: Cautions

    -- are hazards for children and pets. • To prevent shock, connect cables only as described in this Guide. • Do not connect anything to this system other than Philips Telemonitoring Services devices or glucose meters approved by your healthcare provider. •...
  • Page 13: Display Symbols

    Display Symbols Display Symbols A number of symbols are displayed on various devices or in documentation of the Philips Telemonitoring System. Their meaning and the devices on which they may appear are given in the following table. Symbol Description Applicable Devices...
  • Page 14 Display Symbols Symbol Description Applicable Devices Meets Class B standards. Home Hub/TeleStation Standard Scale Steady Scale Blood Pressure Unit Rhythm Strip Recorder Pulse Oximeter Standard Scale Meets Part 15 standards. Steady Scale Blood Pressure Unit Rhythm Strip Recorder Pulse Oximeter Home Hub/TeleStation Meets Part 68 standards Introduction...
  • Page 15: Philips Telemonitoring Set

    Philips Telemonitoring Set Overview Chapter 2 provides a detailed description of the devices of the Philips Telemonitoring Set and how to use them. It includes the following. Page Device Descriptions ..... . . 2-2 Home Hub/TeleStation .
  • Page 16: Device Descriptions

    Device Descriptions Device Descriptions The Philips Telemonitoring Set consists of a Home Hub or TeleStation, which serves as the "communications center" of the system, and one or more devices that measure an important healthcare parameter -- Scale (weight), Blood Pressure Unit (blood pressure), Rhythm Strip Recorder (heart rhythm), Pulse Oximeter (%SpO , pulse rate).
  • Page 17: Front Panel Lights

    The following Warnings apply to the use of Home Hub/TeleStations. Warning • Use only the Philips-supplied power adapter for the Home Hub/ TeleStation. – Don’t place anything on top of the adapter. – Plug the adapter into an outlet near the Home/Hub Telestation for easy access.
  • Page 18: Cautions

    If you are using a glucose meter connected to your TeleStation: – Follow the glucose meter manufacturer’s instructions. – Follow any additional instructions from your healthcare provider. – Do not take glucose measurements while your glucose meter is connected to your TeleStation. Philips Telemonitoring Set...
  • Page 19: Scale

    Steady Scale The Steady Scale has a column with grab bars to help people keep their balance when using the Scale. It has a maximum weight limit of 365 lbs (166 kgs). Display Grab Bars Column Platform Philips Telemonitoring Set...
  • Page 20: Warnings

    Carpet feet may need to be installed on the Steady Scale if it is to be used on carpet. • Traveling with the Scale is not recommended. Note If you don’t feel comfortable taking your weight using the Standard Scale, contact your healthcare provider. Philips Telemonitoring Set...
  • Page 21: Blood Pressure Unit

    BP Unit The display case has a START/STOP button and a RADIO TEST Display Case button BP Display Unit START/ STOP Button RADIO TEST Button Air Hose Cuff Philips Telemonitoring Set...
  • Page 22: Warnings

    – If the numbers go up to 330 mmHg, press the START/STOP button immediately. – If the numbers drop down to 15 mmHg and stay that way for more than 3 minutes, press the START/STOP button again. – Contact your healthcare provider. Philips Telemonitoring Set...
  • Page 23: Rhythm Strip Recorder

    Rhythm Strip The display case has a START button, a RELAX light, and a RADIO Recorder TEST button Display Case Rhythm Strip Recorder Display Unit Relax Light START Button RADIO TEST Button Dual Cable Wristbands Snap-on Connectors Philips Telemonitoring Set...
  • Page 24: Warnings

    It will interfere with the radio signal to the Home Hub/TeleStation. • Store the Recorder so that the dual cable is not twisted or kinked. • Avoid tugging at the dual cable or carrying the Recorder by the cable. 2-10 Philips Telemonitoring Set...
  • Page 25: Pulse Oximeter

    Light transmitted through the blood in your finger is received by a photo sensitive element and electronics in the display case uses the transmitted light to determine your blood oxygen level and pulse rate. Display START button Radio Test button Finger-clip sensor 2-11 Philips Telemonitoring Set...
  • Page 26: Warnings

    • Use of this device is not a substitute for medical care. • If you have any questions regarding how to use your Pulse Oximeter, please contact your healthcare provider. • Abnormal hemoglobin may affect accuracy. 2-12 Philips Telemonitoring Set...
  • Page 27: Device Usage

    Device Usage Device Usage This section describes how to use each of the devices of the Philips Telemonitoring Set -- HomeHub/TeleStation, Scale, Blood Pressure Unit, Rhythm Strip Recorder, and Pulse Oximeter. Home Hub/ The Home Hub or TeleStation is the communications center for your TeleStation Patient Telemonitoring Set.
  • Page 28: Answering Survey Questions

    – Select the go back button and choose your answer again. 2.After you select an answer, the next question is displayed. Step 2. – Select and answer it by pushing a button. – Answer all of the questions. 2-14 Philips Telemonitoring Set...
  • Page 29 When you have finished the survey, the holding results light Step 4. will come on followed by the using phone light, showing that your results are being sent to your healthcare provider’s computer. 2-15 Philips Telemonitoring Set...
  • Page 30: Entering Measurements Manually

    TeleStation do not go back on/survey holding using press waiting results phone go back Press the button next to the measurement you want to enter, Step 3. or, press the More button to see other measurements. 2-16 Philips Telemonitoring Set...
  • Page 31 Continue to move to the next part of the entry. When you have finished entering your measurement: Press the All Finished button to store your measurement. Step 5. Repeat Steps 3-5 to enter your other measurements. Step 6. 2-17 Philips Telemonitoring Set...
  • Page 32: Entering Glucose Meter Results

    Notes Do not measure your glucose while your Glucose Meter is connected to the TeleStation. Clean your finger of blood before using the TeleStation. TeleStation Glucose Meter Cable 2-18 Philips Telemonitoring Set...
  • Page 33: Changing Glucose Meter Time And Date

    Step 4. connected to the TeleStation. The Philips Telemonitoring System relies on the Glucose Meter’s date and time to calculate the actual date and time of the glucose reading. This gives the clinician the most accurate time of measurement, regardless of whether the meter time is set correctly.
  • Page 34: Scale

    If the batteries in the Scale are weak, the Scale’s display will alternately flash Lo and batt and will announce "Please replace the scale batteries" for 3 measurement cycles. If these messages appear on the display, change the Scale’s batteries following the Replacing Batteries procedure on page 3-4. 2-20 Philips Telemonitoring Set...
  • Page 35 Silent. If these messages appear on the display, change the Scale’s batteries following the Replacing Batteries procedure on page 3-4. 2-21 Philips Telemonitoring Set...
  • Page 36 If the batteries in the Scale are weak, the Scale’s display will flash Lo and batt alternatingly instead of Walking "-". If these messages appear on the display, change the Scale’s batteries following the Replacing Batteries procedure on page 3-4. 2-22 Philips Telemonitoring Set...
  • Page 37 Step off the Scale. Step 5. About 5 seconds after you step off the Scale, the Scale will say (unless the volume is set to Silent) and display your final weight. The Scale then turns off by itself. 2-23 Philips Telemonitoring Set...
  • Page 38 Silent. If these messages appear on the display, change the Scale’s batteries following the Replacing Batteries procedure on page 3-4. 2-24 Philips Telemonitoring Set...
  • Page 39 Stop the procedure when you reach the desired voice volume. Step 4. Note If you set the volume to Silent, there will be no voice prompt and you must watch the Scale’s display for instruction lights and your weight measurement. 2-25 Philips Telemonitoring Set...
  • Page 40: Changing The Weight Units

    Turn the Scale over to expose its under side, shown in the Step 1. following figure. Weight Language Change Change Switch Switch Battery Compartment Switches Locate the Weight Change Switch in the opening below the Step 2. Battery Compartment. Step 3. 2-26 Philips Telemonitoring Set...
  • Page 41: Changing Language

    Turn the Scale over to expose its under side, shown in the Step 1. following figure. Weight Language Change Change Switch Switch Battery Compartment Switches Locate the Language Change Switch in the opening below Step 2. the Battery Compartment. 2-27 Philips Telemonitoring Set...
  • Page 42 Device Usage Step 3. 2-28 Philips Telemonitoring Set...
  • Page 43: Blood Pressure Unit

    If you travel with the BP Unit, it will store up to 19 readings for up to 11 days with good batteries that remain in the device. When you return home to your Home Hub/TeleStation, the readings will be sent automatically to your healthcare provider’s computer. 2-29 Philips Telemonitoring Set...
  • Page 44: Display Symbols

    There may be a problem with your equipment. Wait 15minutes and take your blood pressure again. If there is still a problem, you may be able to fix the problem by looking in the Troubleshooting section. If not, call your healthcare provider. 2-30 Philips Telemonitoring Set...
  • Page 45 Make sure that your hand is open, relaxed with the palm up. Step 7. Press the START/STOP button. The cuff will inflates and feel Step 8. tight. Sit still and do not move your arm during the measurement. 2-31 Philips Telemonitoring Set...
  • Page 46 If an error message was displayed, you stopped the reading, or you feel that the reading may be incorrect, wait 5 minutes and take your blood pressure again. If this happens a second time, contact your healthcare provider. 2-32 Philips Telemonitoring Set...
  • Page 47 Store the BP Unit within 20 feet of the Home Hub/TeleStation Step 11. so it can send your readings to the Home Hub/TeleStation. Note Refer to the Maintenance section for proper storage of your BP Unit. 2-33 Philips Telemonitoring Set...
  • Page 48: Rhythm Strip Recorder

    Place the wristband with the red snap-on connector on your left Step 4. wrist. Make sure that the flat metal inside the wristband (on the other side of the black plastic pad) firmly touches the inside of your wrist. 2-34 Philips Telemonitoring Set...
  • Page 49 Store the Recorder within 20 feet of the Home Hub/TeleStation Step 8. so it can send you measurements to the Home Hub/TeleStation. Note Refer to the Maintenance section for proper storage of your Rhythm Strip Recorder. 2-35 Philips Telemonitoring Set...
  • Page 50: Pulse Oximeter

    If you have anemia, a low hemoglobin count, or arrhythmias, you may not be able to get a correct reading. Contact your healthcare provider. Caution Do not use the Pulse Oximeter with the battery door open. 2-36 Philips Telemonitoring Set...
  • Page 51 Sit comfortably with your hand Step 3. resting on the surface so that it can remain still. Press the START button and hold your hand still during the Step 4. measurement. Press Start button Hold hand still 2-37 Philips Telemonitoring Set...
  • Page 52 - The tick-tock sequence repeats several times and then turns off. Note If the measurement was not made, a long beep sounds and displays: Warm your hand or use a different finger and try again. 2-38 Philips Telemonitoring Set...
  • Page 53: Maintenance

    Maintenance Overview Chapter 3 provides steps for cleaning and storing Patient Telemonitoring devices, replacing batteries, and general maintenance of the Patient Telemonitoring Set. You can help keep your devices in working order by taking good care of them. This chapter includes the following sections: Page Cleaning Devices .
  • Page 54: Cleaning Devices

    Cleaning Devices Cleaning Devices Telemonitoring devices should be cleaned only when necessary. The following procedure should be followed to clean the devices. Note Body fluids, such as blood or mucus, should be promptly removed using a cloth dampened with plain tap water (no soap). Caution Avoid spilling liquids on the devices.
  • Page 55: Storing Devices

    Storing Devices Storing Devices All measurement devices should be stored within 20 feet of the Home Hub or TeleStation so they can send their results to the Home Hub or TeleStation. Caution Do not store devices inside or next to a metal drawer or container, such as a file cabinet.
  • Page 56: Replacing Batteries

    Replacing Batteries Replacing Batteries Batteries in devices should be replaced as soon as the device indicates that they are low or need to be replaced. Caution When replacing batteries, replace all of the batteries with new ones at the same time. Use only Type AA (1.5 volt) alkaline batteries Do not use rechargeable batteries.
  • Page 57: Standard Scale

    Replacing Batteries Standard Scale Lift and gently turn the scale upside down on a flat surface to Step 1. expose the Battery Compartment. Battery Compartment Lift tab and remove cover Remove the cover of the Battery Compartment by lifting the tab. Step 2.
  • Page 58 Replacing Batteries Replace the cover by inserting its tabs into the slots and gently Step 5. pressing the cover into place. Return the Scale to its original spot following proper lifting Step 6. techniques given below. Note Lifting the Scale requires good balance, the ability to grasp and lift up to 10 pounds, and safe lifting techniques.
  • Page 59: Steady Scale

    Replacing Batteries Steady Scale Firmly hold the display and pull it from the Scale to release it Step 1. from the plastic fastener strips that hold it in place. Turn the display over and unplug the cord inside the top of the Step 2.
  • Page 60 Replacing Batteries The display will then show 8.8.8.8 briefly, and the Step Off light will flash slowly. Replace the display as follows: Step 7. – Place the connection cord through the display cutout. – Hold the scale display above the top of the column with the display facing you.
  • Page 61: Blood Pressure Unit

    Replacing Batteries Blood • Replace the batteries in the Blood Pressure Unit every 3 months or Pressure sooner if required. The expected battery life for the BP Unit is Unit approximately 3 months with 1 daily reading. • Replace the batteries in the BP Unit when you see the Low Battery symbol on the BP Unit display.
  • Page 62: Rhythm Strip Recorder

    Replacing Batteries Replace the cover by inserting its tabs into the slots and gently Step 5. pressing the cover into place. Perform the Radio Test described in Troubleshooting. Step 6. Take your Blood Pressure and verify that it is working properly. Step 7.
  • Page 63: Pulse Oximeter

    Replacing Batteries Pulse • Replace the batteries in the Pulse Oximeter every 6 months or Oximeter sooner if required. • The batteries should be replaced when the Low Battery indicator flashes on the Pulse Oximeter display. • The Rhythm Strip Recorder uses 4 AA alkaline batteries. Procedure To replace the batteries in the Rhythm Strip Recorder, follow Step 1 through Step 5 of the procedure for the Blood Pressure Unit on...
  • Page 64 Replacing Batteries 3-12 Maintenance...
  • Page 65 Troubleshooting Overview Chapter 4 describes procedure to follow if you have problems with the Patient Telemonitoring system or any of its devices. The tables on the following pages can serve as a guide to help resolve problems that may occur. Caution Do not try to repair any device yourself.
  • Page 66: Troubleshooting

    Overview Radio Test If the remeasurement still does not seem to work properly and the error message continues to appear, another step that can be taken is to perform a Radio Test. The Radio Test makes sure that your measurements are being properly sent from the measurement device to the Home Hub/TeleStation.
  • Page 67: Troubleshooting Tables

    Troubleshooting Tables Troubleshooting Tables The following tables gives possible Problems that can occur, Reasons why they may have occurred, and Possible Solutions that should be tried to resolve the problem. Find the Problem entry that seems to describe what you observe, and then try the various Possible Solutions.
  • Page 68 Troubleshooting Tables Problem Reason Possible Solutions When you take a There may be a problem with Perform the CALL button test as follows: measurement, the your telephone service or you - Find the CALL button on the far right of data/holding results healthcare provider’s the back panel of the Home Hub/...
  • Page 69 Troubleshooting Tables Problem Reason Possible Solutions When you take a There may be a conflict - Have someone call and leave a message on measurement, the between your special phone you special telephone service data/holding service and the Home Hub/ Perform the CALL button test as follows: results light TeleStation connection,...
  • Page 70 Troubleshooting Tables Problem Reason Possible Solutions Continued from - After a few minutes, the using phone previous page light and the data/holding results light should turn off. - If the data/holding results light turns off, the Home Hub/TeleStation is operating correctly.
  • Page 71 Troubleshooting Tables Problem Reason Possible Solutions Liquid spilled onto The Home Hub/TeleStation For liquid spills, do the following: the Home Hub/ should be placed far from - Unplug the Home Hub/TeleStation power TeleStation liquids (especially a sink or adapter from the wall or power strip. (for example, where anywhere liquids might spill - Unplug the phone connection cord from the...
  • Page 72: Scale

    Troubleshooting Tables Scale The following table describes problems that may occur with the each of the two types of Scale -- Standard Scale and Steady Scale. Use the table for your type of Scale. Standard The following troubleshooting table applies to the Standard Scale. Scale Problem Reason...
  • Page 73: Steady Scale

    Troubleshooting Tables Steady Scale The following troubleshooting table applies to the Steady Scale. Problem Reason Possible Solutions Err. appears on the Take your weight again and wait for the Step You stepped off the Scale too Off light and voice prompts before stepping display soon.
  • Page 74: Rhythm Strip Recorder

    Troubleshooting Tables Problem Reason Possible Solutions Scale does not turn The Scale is not properly - Check the cord connection between the installed or the batteries are platform and the display. low. - Replace all 4 Scale batteries following the procedure in Chapter 3.
  • Page 75: Blood Pressure

    Troubleshooting Tables Blood The following table describes problems that may occur with the Blood Pressure Pressure Unit. Unit Problem Reason Possible Solutions Inaccurate blood Improper blood measurement Review the blood pressure tips in Chapter 2 pressure readings. procedure. and repeat the measurement. appears on The systolic and diastolic - Check that the air hose is properly...
  • Page 76 Troubleshooting Tables Pulse The following table describes problems that may occur with the Pulse Oximeter Oximeter. Problem Reason Possible Solutions appears on A hardware malfunction is If condition persists, contact your healthcare the display detected. provider. appears A reading was not obtained. - Reduce the light.
  • Page 77 Specifications and Regulatory Overview Chapter 5 provides information about the Philips Telemonitoring Set of devices that is required by law to completely describe their characteristics, performance and compliance with regulatory requirements. It includes the following sections. Page Specifications ......5-2 Description .
  • Page 78 Specifications Specifications This section gives technical descriptions and specifications of the Philips Telemonitoring Set devices, including physical, electrical, and environmental. Description Home Hub/TeleStation Home Hub: M3812A Model TeleStation: M3812B Class II equipment, continuous operation Type Display LED lights on both models...
  • Page 79 Specifications Steady Scale Model M3813A Type - Type B applied part - IPXO ordinary equipment - Internally powered continuous operation Display - Digital, 0.71 in (18 mm) character height - Weights displayed and announced simultaneously Language English only Audio Volume Voice readout of weight, prompts, and 4 settings Measurement 66 to 365lbs (30 to 166 kg)
  • Page 80: Blood Pressure Unit

    Specifications Blood Pressure Unit Model M3815A Type - Type B applied part oscillometric - IPXO ordinary equipment - Internally powered continuous operation Display - Digital, 0.63 in (16 mm) character height - Pressure/pulse displayed simultaneously Measurement - Pressure: 20 to 280 mm Hg Range - Pulse: 40 to 200 pulses per minute Accuracy...
  • Page 81: Pulse Oximeter

    Specifications Pulse Oximeter Model M3814A Type - Type B applied part - IPXO ordinary equipment - internally powered continuous operation (does not imply continuous monitoring Display - Digital 0.7 in. (1.8 cm) character height - SpO - Pulse displayed alternately - SpO display range: 0 - 100% Measurement...
  • Page 82: Home Hub/telestation

    Electrical Product Philips Device Power Source Battery Life Part # Home Hub M3812A 9.0VAC/ 500mA (Use Philips-supplied power adapter only) TeleStation M3812B Standard Scale M3813B 4 AA (1.5V) alkaline batteries ~ 12 months with connected in series 1 daily measurement...
  • Page 83: Environmental

    Specifications Environmental Atmospheric Relative Temperature Altitude Pressure Humidity Philips Device Operating and Operating and (Non- Product condensing) Operating Storage Storage Storage Part # (hPa) (hPa) Home Hub M3812A 10 - 40 -9 - 54 572-1013 0-4600m less than (50 - 104...
  • Page 84: Electromagnetic Compatibility

    Electromagnetic compatibility with surrounding devices should be assessed prior to using this equipment. Philips Telemonitoring Set devices should not be used next to or stacked with other equipment. If you must stack the device, check that normal operation is possible.
  • Page 85: Avoiding Electromagnetic Interference Problems

    0.05 V/m. The phenomena discussed above are not unique to this unit but are characteristic of radio instrumentation in use today. The M3812A Home Hub and M3812B TeleStation are radio receivers and their reception of Philips Telemonitoring Set device signals can be degraded by electromagnetic interference.
  • Page 86: Regulatory Information

    Philips could void the user’s authority to operate it. The possibility of hazards arising from errors in the software program is minimized by Philips’ use of a risk analysis and risk management process as defined in Philips’ document CM RISK ANALYSIS PROCESS, document number A-Q2920-00126.
  • Page 87: Telephone Regulatory Notice

    FCC Part 68 ID Number: 2M6USA-33569-DT-E and Ringer Equivalence Number (REN): 0.3A. Your Philips TeleStation complies with Part 68 of the FCC rules and the requirements adopted by the Administrative Council for Terminal Attachments (ACTA). ACTA requires Philips to provide you with the following information.
  • Page 88 Consult your telephone company or qualified installer if you are using a TeleStation and have specially wired alarm equipment connected to your telephone line. Contact Philips Medical Systems at (978) 687-1501 for repair or warranty information. 5-12 Specifications and Regulatory...

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