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Specifications and Regulatory

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5

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

Intended Use/Indications for Use . . . . . . . . . . . . . . . . . . . . . . . . 5-2

Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-3

Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-3

Home Hub  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-3
Standard Scale . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-4
Steady Scale  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-5
Blood Pressure Monitor  . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-6
Rhythm Strip Recorder . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-7
Pulse Oximeter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-7

Technical Specifications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-9

Physical . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-9
Electrical . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-9
Environmental . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-10

Electromagnetic Compatibility (except M3813B and M3815B) 5-11

Emissions and Immunity . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-12

Avoiding Electro-magnetic Interference . . . . . . . . . . . . . . 5-12
Avoiding Static Electrical Discharges . . . . . . . . . . . . . . . . 5-13

Electromagnetic Compatibility (M3813B and M3815B) . . . . . . 5-14

Emissions and Immunity . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-15

Reducing Electro-magnetic Interference . . . . . . . . . . . . . 5-15

Regulatory Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-20

FCC Regulations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-20
Telephone Regulatory Notice . . . . . . . . . . . . . . . . . . . . . . . . . 5-21

All manuals and user guides at all-guides.com

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Содержание M3812A

Страница 1: ...All manuals and user guides at all guides com a l l g u i d e s c o m ...

Страница 2: ...2 All manuals and user guides at all guides com ...

Страница 3: ...e Philips Electronics N V 2008 All Rights are reserved Reproduction in whole or in part in any form or by any means electrical mechanical or otherwise is prohibited without the written consent of the copyright holder Document number M3810 90096 Issue number 5 October 2008 Philips Medical Systems 3000 Minuteman Road Andover MA 01810 1085 USA Unauthorized copying of this publication is a copyright i...

Страница 4: ...ument part number changes when extensive technical changes are incorporated All Editions and Updates of this manual and their publication dates are listed below First Edition October 2002 Second Edition July 2006 Third Edition May 2007 Fourth Edition May 2008 Fifth Edition October 2008 Personal Health Information Security Telehealth equipment collects personal information in the form of vital sign...

Страница 5: ... 3 Cautions 1 4 Notes 1 4 Bold Typeface 1 4 Display Symbols 1 5 2 Philips Telemonitoring Set 2 1 Overview 2 1 Device Descriptions 2 2 Home Hub TeleStation 2 2 Indicators 2 3 Warnings 2 3 Cautions 2 4 Scale 2 5 Standard Scale 2 5 Steady Scale 2 5 Warnings 2 6 Cautions 2 6 Blood Pressure Monitor 2 7 BP Monitor Display Case 2 7 Warnings 2 8 Cautions 2 8 Rhythm Strip Recorder 2 9 Rhythm Strip Recorder...

Страница 6: ...4 Changing Voice Volume 2 26 Changing Language 2 27 Changing Weight Units 2 27 Standard Scale 2 28 Steady Scale 2 29 Blood Pressure Monitor 2 30 Measuring Blood Pressure 2 31 Procedure for M3815A Blood Pressure Monitor 2 31 Procedure for M3815B Blood Pressure Monitor 2 35 Rhythm Strip Recorder 2 38 Measuring Heart Rhythm 2 38 Pulse Oximeter 2 40 Measuring Blood Oxygen and Pulse Rate 2 41 Procedure...

Страница 7: ...4 Standard Scale 2 5 Steady Scale 2 7 Blood Pressure Monitor 3 9 Procedure 3 9 Rhythm Strip Recorder 3 10 Procedure 3 10 Pulse Oximeter 3 12 Procedure 3 12 4 Troubleshooting 4 1 Overview 4 1 Radio Test 4 2 Troubleshooting Tables 4 3 Home Hub Telestation 4 3 Scale 4 8 Standard Scale 4 8 Steady Scale 4 9 Rhythm Strip Recorder 4 10 Blood Pressure Monitor 4 11 Pulse Oximeter 4 13 All manuals and user ...

Страница 8: ...ulse Oximeter 5 7 Technical Specifications 5 9 Physical 5 9 Electrical 5 9 Environmental 5 10 Electromagnetic Compatibility except M3813B and M3815B 5 11 Emissions and Immunity 5 12 Avoiding Electromagnetic Interference 5 12 Avoiding Static Electrical Discharges 5 13 Electromagnetic Compatibility M3813B and M3815B 5 14 Emissions and Immunity 5 15 Reducing Electromagnetic Interference 5 15 Regulato...

Страница 9: ...art enough to know when the phone line is open It will wait and then send the information after you hang up Keeping the System Working If at any time you suspect something is wrong with any of the devices immediately contact your healthcare provider Philips will replace any defective device You can also cross check your results with another device if additional measurement devices of the same type...

Страница 10: ...tation using a special cable Your healthcare provider decides whether you will use one or all of the measurement devices below The HomeHub TeleStation is the communications center It receives your measurements from the devices and sends them over your phone line to your healthcare provider s computer The computer keeps a record of all of your vital sign measurements for review by your healthcare p...

Страница 11: ...Warnings Warnings are information you should know to avoid a hazard that could result in severe injury or death Observe the following Warnings with all devices of the Philips Telemonitoring System Warning Do not let anyone else use these devices They are provided for your use only Do not swap devices with a neighbor or family member who has the same or similar system These devices are not intended...

Страница 12: ...e information you should know to avoid a hazard that could result in personal injury or property damage Observe the following Cautions with all devices of the Philips Telemonitoring System Caution Read these Instructions for Use carefully before using devices Use these devices only as directed by your healthcare provider Follow your physician s instructions regarding symptoms that require direct c...

Страница 13: ... M3814A Type BF Patient Applied Parts as defined in IEC 60601 1 Not suitable for direct cardiac application Pulse Oximeter M3814B Attention Consult accompanying documents Home Hub TeleStation Scale M3813A M3813B Blood Pressure Monitor Rhythm Strip Recorder Pulse Oximeter Meets UL 1950 CSA 950 IEC 60950 standards Meets CSA IEC 60950 1 standards Home Hub TeleStation TeleStation Scale M3813A Blood Pr...

Страница 14: ...ome Hub TeleStation Standard Scale Steady Scale Blood Pressure Monitor Rhythm Strip Recorder Pulse Oximeter Meets Part 15 standards Standard Scale Steady Scale Blood Pressure Monitor Rhythm Strip Recorder Pulse Oximeter Meets Part 68 standards Home Hub TeleStation Symbol Description Applicable Devices US All manuals and user guides at all guides com ...

Страница 15: ... 2 15 Home Hub TeleStation 2 15 Home Hub 2 15 TeleStation 2 15 Answering Survey Questions 2 16 Entering Measurements Manually 2 18 Scale 2 21 Measuring Weight 2 21 Measuring Weight with a Walker 2 23 Changing Voice Volume 2 26 Changing Language 2 27 Changing Weight Units 2 28 Blood Pressure Monitor 2 30 Measuring Blood Pressure 2 31 Rhythm Strip Recorder 2 38 Measuring Heart Rhythm 2 38 Pulse Oxim...

Страница 16: ...ill have either a Home Hub or a TeleStation depending on the home healthcare plan designed for you After you take a measurement such as weight the Home Hub TeleStation receives the result It then sends the result to your healthcare provider s computer when both telephone lines yours and the computer s are free If you pick up your telephone while the Home Hub TeleStation is dialing or sending the r...

Страница 17: ...healthcare provider s computer Warnings The following Warnings apply to the use of Home Hub TeleStations Warning Use only the Philips supplied power adapter for the Home Hub TeleStation Do not place anything on top of the adapter Plug the adapter into an outlet near the Home Hub Telestation for easy access Unplug the adapter from the outlet to disconnect Do not place the Home Hub TeleStation where...

Страница 18: ...ances or metal furniture near the Home Hub TeleStation as they can block radio signals from the measurement devices High temperatures can affect the LCD screen of your TeleStation Choose a location away from direct sunlight Operate the TeleStation at room temperature Make sure that the Home Hub TeleStation is plugged into its telephone jack and electrical outlet at all times except when cleaning o...

Страница 19: ...eight limit of 440 lbs 200 kgs The scale announces your weight in English or Spanish The front panel has a Volume control button and a Radio Test button Batteries are stored underneath the platform 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 Platform Grab Bars Column Displa...

Страница 20: ...e in a dry temperature controlled place not in the bathroom Position the Scale away from metal objects such as a refrigerator as they can block transmission to your Home Hub TeleStation Place the Scale on the floor between 1 to 3 inches 2 5 to 7 5 cm from a wall and facing it Only one person should use the Scale Do not use the Scale to measure anything other than yourself such as a package or pet ...

Страница 21: ... slides through and loops over an air hose and an air connector Batteries are stored underneath the display case Note Two models of BP Monitor are available M3815A and M3815B and are shown below Check your BP Monitor to determine which one you have The part numbers are shown on the rear of the monitor BP Monitor Display Case Both monitors have a display window that shows the systolic and diastolic...

Страница 22: ...ain Do not store the BP Monitor inside a metal drawer or container such as a file cabinet It will interfere with the radio signal to the Home Hub TeleStation Do not store the BP Monitor with the cuff assembly twisted or folded tightly Avoid tugging at the air hose or using it to carry the BP Monitor Watch the display when taking your blood pressure If the numbers go up to 330 mmHg press the START ...

Страница 23: ...ectors Each of the two metal wristbands has a black plastic pad One side of the pad has a metal snap and the other side has a flat piece of metal Batteries are stored underneath the display case Rhythm Strip Recorder Display Case The display case has a START button a RELAX light and a RADIO TEST button T Rhythm Strip Recorder Display Unit START Button RADIO TEST Button Relax Light Wristbands Snap ...

Страница 24: ... using the recorder if you have redness rash or other skin problems Contact your healthcare provider Cautions The following Cautions apply to use of the Rhythm Strip Recorder Caution Do not store the Recorder inside a metal drawer or container such as a file cabinet It will interfere with the radio signal to the Home Hub TeleStation Store the Recorder so that the dual cable is not twisted or kinke...

Страница 25: ...nd pulse rate in beats per minute measured from the end of your finger The M3814A has 1 display in which SpO2 and pulse min measurements alternate LEDs below the display light to indicate which measurement is being displayed The M3814B has 2 displays one each for SpO2 and pulse min Pushing the START button causes the Pulse Oximeter to begin taking a measurement The Radio Test button on M3814A on M...

Страница 26: ...under conditions of strong or excessive light infrared lamps photo therapy etc Failure to do so can result in inaccurate measurements Avoid exposing the devices to extremes in temperature humidity direct sunlight shock dust spills or standing water The finger sensor can be comfortably clipped onto the finger not thumb of patients weighing 90 lb If the sensor is too tight it may result in inaccurat...

Страница 27: ...ded maximum time for the sensor to be attached to a finger is no more than 4 minutes more than enough time for a measurement to be obtained Do not leave the finger sensor on the patients finger between measurements This device may not work properly on all people If you are unable to achieve stable readings within 3 or 4 attempts discontinue use and contact your healthcare provider Use of this devi...

Страница 28: ...System operates only with the Bayer Ascensia Contour 7151B OneTouch Basic and OneTouch Profile glucose meters The Bayer Ascensia Contour 7151B operates only with TeleStations with serial numbers SN US4837 and higher The serial number is on the label on the back of the TeleStation under the Philips logo No other glucose meters should be connected to a TeleStation Do not measure your glucose while y...

Страница 29: ...hone line is free Note The Home Hub and TeleStation depend on your phone number to transmit results They cannot be used with phones that have another number Home Hub The Home Hub receives your measurement results from your measurement devices by radio signals and automatically sends them to your healthcare provider s computer No actions are required by you after you have made your measurement Tele...

Страница 30: ...swer survey questions use the following procedure Step 1 Questions show on the screen with answer choices Push the button next to the best answer Choose only one The answer will be highlighted If you make a mistake Select the go back button and choose your answer again Step 2 After you select an answer the next question is displayed Answer it by pushing a button Answer all of the questions TeleSta...

Страница 31: ...answer to an earlier question you will then need to answer all of the questions that follow again The last question will confirm that your responses are complete Step 4 When you have finished the survey the holding results light will come on followed in a few minutes by the using phone light This indicates that your results are being sent to your healthcare provider s computer All manuals and user...

Страница 32: ...ected by your healthcare provider and write down the results Step 2 Press any button except go back A menu screen appears showing the measurements that can be entered Step 3 Press the button next to the measurement you want to enter or press the More button to see other measurements TeleStation go back Please select a Blood Pressure Weight Blood Sugar Temperature Oxygen Level More measurement to e...

Страница 33: ...More or Less buttons When entering Blood Pressure and Oxygen Level measurements press Continue to move to the next part of the entry When you have finished entering your measurement Step 5 Press the All Finished button to store your measurement Step 6 Repeat Steps 3 5 to enter any other measurements TeleStation on survey waiting holding results using phone goback Please enter your More All Finishe...

Страница 34: ...turn on indicating that your measurements are being sent to your healthcare provider s computer Note If you get an invalid reading on your measurement device do not enter it in the TeleStation If you accidently turn on the measurement screen do not press any buttons After a few minutes the screen will go blank All manuals and user guides at all guides com ...

Страница 35: ... in the center of the platform as possible Try not to step on the corners you might damage the Scale Step 2 The Scale will say Please stand still Do not move Walking will show on the display during the measurement Notes You will not hear the voice prompt if the volume is set to 0 After several seconds the Scale will say Please step off the Scale Step 3 Step off the Scale About 5 seconds after you ...

Страница 36: ...not hear the voice prompt if the volume is set to 0 After several seconds the Scale will say Please step off the Scale unless the volume is set to 0 and the Step Off light will come on Step 3 Step off the Scale About 5 seconds after you step off the Scale the Scale will say unless the volume is set to 0 and display your final weight The Scale then turns off by itself Notes If the batteries in the ...

Страница 37: ... take your true weight Step 3 The Scale will say Please stand still Do not move Walking will show on the display during the measurement Notes You will not hear the voice prompt if the volume is set to 0 After several seconds the Scale will say Please step off the Scale Step 4 Grasp the walker arms Step 5 Step off the Scale About 5 seconds after you step off the Scale the Scale will say your final ...

Страница 38: ...ur walker for the Scale to take your true weight Step 4 The Scale will say Please stand still and the Stand Still light will come on Do not move Changing weight values will show on the display The final weight displayed is the correct weight Notes You will not hear the voice prompt if the volume is set to 0 After several seconds the Scale will say Please step off the Scale unless the volume is set...

Страница 39: ...l flash instead of remaining on and the voice prompt is quiet even though the volume is not set to 0 If this message appears on the display or the voice is silent even though it is not set to 0 change the Scale s batteries following the Replacing Batteries procedure on page 3 4 All manuals and user guides at all guides com ...

Страница 40: ...nging the volume Step 2 Firmly press and release the Volume button The volume will move to the next setting For example the Scale may say one and display 1 for Low Step 3 Firmly press and release the Volume button again The volume moves to the next setting In this example the Scale will say two and display 2 for Medium Each time your press the Volume button the volume moves to the next setting Ste...

Страница 41: ... Battery Compartment Step 3 Press and release the Language Select button to change the language The Scale will speak the next language English or Spanish Step 4 Repeat the press and release procedure until the desired language is spoken When the desired language is spoken the procedure is completed and that language will be spoken by the scale during weight measurements RJ11 Language Select KG LB ...

Страница 42: ...he KG LB Units button in the opening above the Battery Compartment Step 3 Press and release the KG LB Units button to change the weight units The Scale will speak the next unit Kilograms or Pounds Kilogrammas or Libras in Spanish Step 4 Repeat the press and release procedure until the desired unit is spoken Step 5 When the desired unit is spoken the procedure is completed and that unit will be spo...

Страница 43: ...rmly press both the Volume button and the Radio Test button at the same time Hold both buttons down for at least 3 seconds If the Scale had been measuring pounds the display will now show Kgs for kilograms If the Scale was measuring kilograms the scale will now show Lbs for pounds The voice will also say the new weight units unless the volume is set to 0 T All manuals and user guides at all guides...

Страница 44: ...y tight clothing on the arm you will use to measure your blood pressure or roll up a loose garment sleeve Do not measure with the cuff over clothing Place the cuff 1 inch above the elbow with the air hose on the inside of your arm Leave room for two fingers under the cuff Sit still and do not move your arm during the measurement Notes You can lie down while someone else takes your blood pressure b...

Страница 45: ...or M3815A Blood Pressure Monitor The following table describes symbols you may see on the M3815A BP Monitor display during the measurement T Symbol Meaning The blood pressure measurement is taking place The symbol blinks and beeps with each pulse beat The symbol may also appear briefly at the start of your blood pressure measurement The batteries need to be replaced This symbol may also appear bri...

Страница 46: ...bout 1 inch above your elbow Step 4 Position the air hose so it dangles on the inside of your arm Warning Do not allow the air hose to kink or twist Step 5 Pull on the end of the cuff to tighten it Then fold the cuff end back over the metal D ring Note The cuff should be snug but not too tight Leave room for two fingers to fit under the cuff Step 6 Fasten the end of the cuff to the Velcro closure ...

Страница 47: ...t your healthcare provider Step 9 As the cuff pressure slowly decreases watch the display window The BP Monitor will beep as the pressure decreases Warning Watch the display If the numbers drop down to 15 mmHg and stay there for more than 3 minutes press the START STOP button to stop the measurement Contact your healthcare provider A long beep indicates that your blood pressure has been taken The ...

Страница 48: ...Once properly adjusted the cuff can be slid off without undoing the Velcro Step 11 Store the BP Monitor within 20 feet of the Home Hub TeleStation so it can send your readings to the Home Hub TeleStation Note Refer to the Maintenance section for proper storage of your BP Monitor All manuals and user guides at all guides com ...

Страница 49: ...s should be replaced There was a problem with the measurement such as Unstable blood pressure due to excessive body movement Pulse not detected correctly Systolic and diastolic values within 10 mmHG of each other Take your blood pressure again being sure to remain very still during the measurement Cuff is not fastened correctly Refasten the cuff Take your blood pressure again If there is still a p...

Страница 50: ...securely with the hook and loop fastener strap Note The cuff should be snug but not too tight You should be able to insert two fingers between the cuff and your arm Make sure that your hand is open and relaxed with the palm up Remain still and do not talk or move your arm during the measurement Step 5 Press the START STOP button All display symbols appear briefly and the display then changes as th...

Страница 51: ...played The cuff will then deflate and the BP Monitor automatically shuts off after 45 seconds or you can turn it off by pressing the START STOP button Note If an error message was displayed you stopped the reading or you feel that the reading may be incorrect take your blood pressure again If this happens a second time contact your healthcare provider Step 6 Remove the cuff Step 7 Store the BP Mon...

Страница 52: ...ically to your healthcare provider s computer Caution Do not talk or move during the measurement Measuring Heart Rhythm The procedure for measuring your Heart Rhythm is as follows Step 1 Sit back in a chair with your arms at your sides or on the chair arms Do not cross your legs Keep your feet flat on the floor Step 2 Place the Recorder on the table next to you so you can see it and listen to it w...

Страница 53: ...g made Notes If the Recorder beeps twice quickly before beginning the normal beeping this means that the batteries are low Replace the batteries within a week The beeps do not reflect your heart rate They indicate that the Recorder is working After another short pause the relax light flashes on and off twice and the Recorder will quickly beep twice The Recorder has finished taking your heart rhyth...

Страница 54: ...arm or take your Pulse Oximeter measurement first Use the same finger each time you make a measurement unless your healthcare provider instructs otherwise Do not use the sensor on a finger that has chronically poor circulation or is injured Be sure the inside of the finger sensor is dry before taking your measurement Be sure your finger is warm when you take your measurement If your finger is cold...

Страница 55: ...ng steps describe how to use the M3814A Pulse Oximeter to measure your blood oxygen level SpO2 and pulse rate By default pulse rate is turned off To turn pulse on press and hold both the START and test buttons for more than 3 seconds Repeating this step will turn pulse off again Step 1 Sit within 20 ft of the Home Hub or TeleStation with your hand resting on a flat surface and the Pulse Oximeter i...

Страница 56: ...Dashes move across the display during measurement A double beep sounds after a few seconds indicating that the measurement is complete A tick sounds as the SpO2 measurement displays and the yellow light next to SpO2 illuminates Press Start button Hold hand still SpO2 pulse min SpO2 pulse min All manuals and user guides at all guides com a l l g u i d e s c o m ...

Страница 57: ...he green light next to pulse min illuminates 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 SpO2 pulse min All manuals and user guides at all guides com ...

Страница 58: ...it within 20 ft of the Home Hub or TeleStation with your hand resting on a flat surface and the Pulse Oximeter in front of you Step 2 Open the sensor and fully insert your finger index middle or ring but not your thumb until the end of your finger reaches the finger stop The cable should extend over your finger toward your wrist as shown in the figure Step 3 Sit comfortably with your hand resting ...

Страница 59: ...es on off replace the batteries and repeat the measurement See Replacing Batteries on page 3 12 After several seconds the SpO2 measurement and Pulse min rate display Note The Pulse rate may not display if it was not turned on by your healthcare provider After 15 seconds the Pulse Oximeter turns off SpO2 Pulse min SpO2 Pulse min All manuals and user guides at all guides com ...

Страница 60: ...as shown opposite Warm your hand or use a different finger and try again If there is a problem the display shows as shown opposite and then goes blank Warm your hand or use a different finger and try again If it still shows contact your healthcare provider All manuals and user guides at all guides com ...

Страница 61: ...e TeleStation Clean your finger of blood before using the TeleStation Note For procedures on how to measure your glucose with your Glucose Meter refer to its Instructions for Use manual Recording Glucose Measurements Follow these steps to send your Glucose Meter measurements to your healthcare provider s computer via the TeleStation Step 1 Measure your glucose with your Glucose Meter following the...

Страница 62: ...r is turned on Note The Glucose Meter Cable for the Bayer Ascensia Contour 7151B glucose meter is different from the Cable for the OneTouch Basic and OneTouch Profile glucose meters See the following figure Step 6 Turn the Glucose Meter on OneTouch meters should already be see Step 2 The TeleStation will detect the Glucose Meter and TeleStation Glucose Single Pin Connector Meter Cable Bayer Ascens...

Страница 63: ...eter This gives the clinician the most accurate date and time of measurement Therefore it is important for the Glucose Meter s date and time to be set correctly If it is necessary to correct the date or time in your Glucose Meter follow the steps below to ensure that the date and time of your glucose measurements are accurate when you transmit them via the TeleStation Step 1 Connect your Glucose M...

Страница 64: ...help keep your devices in working order by taking good care of them This chapter includes the following sections Page Cleaning Devices 3 2 Storing Devices 3 3 Blood Pressure Monitor 3 3 Rhythm Strip Recorder 3 3 Pulse Oximeter 3 3 Replacing Batteries 3 4 Scale 3 4 Standard Scale 3 5 Steady Scale 3 7 Blood Pressure Monitor 3 9 Rhythm Strip Recorder 3 11 Pulse Oximeter 3 12 All manuals and user guid...

Страница 65: ...Step 1 Unplug the Home Hub TeleStation from power and phone lines Step 2 Remove batteries from the measurement devices following procedures given in the Replacing Batteries section Step 3 Clean all exposed device surfaces with a dry soft cloth Note When cleaning the Pules Oximeter Open the Finger clip sensor and carefully wipe its inside surfaces with a cloth dampened with a mild detergent Allow t...

Страница 66: ...assemblies Blood Pressure Monitor Store the BP Monitor so that the hose and cuff assembly are not bent twisted or folded tightly Do not wrap the hose around the display case RhythmStrip Recorder Store the Rhythm Strip Recorder so that the cable is not twisted or folded tightly The Recorder can be stored with its connectors attached to the wristbands Pulse Oximeter Store the Pulse Oximeter so that ...

Страница 67: ... 12 months or sooner if the voice prompt is absent even though the volume was not set to 0 the display screen alternately displays Lo and batt during a measurement the Scale announces Please replace the scale batteries during a measurement Replace the batteries in the Steady Scale every 6 months or sooner if the voice prompt is absent even though the volume was not set to 0 the normally steady Sta...

Страница 68: ...nd properly dispose of them Note Check with your local authorities for the proper way to dispose of batteries Step 4 Place the new batteries in the Battery Compartment so that the positive and negative terminals match the diagram in the compartment Notes Make sure that battery terminals are touching compartment terminals R J 1 1 L a n g u a g e S e l e c t K G L B Battery Compartment Lift tab and ...

Страница 69: ...ce or contact your healthcare provider for help When you lift or lower the Scale Wear shoes with nonslip soles Keep your feet apart and one foot a bit in front of the other if possible Squat to lift and lower the Scale Never bend at the waist Keep the Scale close to your body Lift with your legs not your back If you must turn turn with your feet not your body Step 7 Perform the Radio Test describe...

Страница 70: ...e proper way to dispose of batteries Step 5 Place the new batteries in the Battery Compartment so that the positive and negative terminals match the diagram in the compartment Notes To keep the batteries from popping out insert the bottom row first Make sure that the battery terminals are touching the compartment terminals Step 6 Replace the cover by inserting its tabs into the slots and gently pr...

Страница 71: ... stops flashing the Scale will say zero pounds display 0 0 and then turn off Note Important Do not step on the Scale while doing this step If the Step Off light does not stop flashing check the cord connections by unplugging the cord and replugging it in until it snaps into place Also check that the batteries are inserted the right way Step 8 Return the Scale to its original spot Caution Do not li...

Страница 72: ...ntly push the Battery Compartment cover in the direction of the arrow symbol and lift it off Step 3 Remove the old batteries and throw them away Note Check with your local authorities on the best way to recycle or throw away batteries Step 4 Place the new batteries in the Battery Compartment so that the positive and negative terminals match the diagram in the compartment Diagrams for both the M381...

Страница 73: ...orm the Radio Test described in Troubleshooting Step 7 Take your Blood Pressure and verify that it is working properly Note If the Blood Pressure Monitor does not seem to be operating properly or the Radio Test fails contact your healthcare provider 2 Insert top row second 1 Insert bottom row first M3815B All manuals and user guides at all guides com ...

Страница 74: ...ow the procedure for the Blood Pressure Monitor on page 3 9 except for Step 7 The Recorder will make a series of beeps If the series ends with a rising tone the batteries have been inserted correctly If the series ends with a falling tone or no tone the batteries have been inserted the wrong way Repeat the battery insertion steps After Step 6 Step 7 Measure your heart rhythm with the Rhythm Strip ...

Страница 75: ... of the procedure for the Blood Pressure Monitor on page 3 9 After battery replacement M3814A displays the message If the message appears replace the batteries with known good batteries and try again M3814B self tests for 6 seconds after which the full battery symbol appears on the lower display for 5 seconds If the depleted battery symbol flashes replace the batteries with known good batteries an...

Страница 76: ...ce provides an error message when some part of the system is not working properly If you see an error message on a device the first thing to do is to check the device and try the measurement again Be sure to follow the voice and light prompts provided by the device to assure that the measurement is being made properly This chapter includes the following sections Page Radio Test 4 2 Troubleshooting...

Страница 77: ...he following messages will appear on the indicated device The Scale and Pulse Oximeter will display rF The Rhythm Strip Recorder s RELAX light will flash once per second The Home Hub TeleStation should beep If the Home Hub TeleStation does not beep do the following Make sure the measurement device has fresh batteries see if there are any large objects between the measurement device and the Home Hu...

Страница 78: ...g table describes problems that may occur with the Home Hub or TeleStation Problem Reason Possible Solutions The screen is unreadable The Home Hub TeleStation may be hot from sitting in sunlight or storage at a high temperature Let the Home Hub TeleStation cool to room temperature and the screen display may be restored When taking a measurement the data holding results light does not turn on There...

Страница 79: ...nce For some Home Hubs you may need to use a pen or other pointed object to depress the CALL button Release the CALL button In 10 seconds the using phone light should turn on and the Home Hub TeleStation will dial your healthcare provider After a few minutes the using phone light and the data holding results light should turn off If the data holding results light turns off the Home Hub TeleStation...

Страница 80: ...tation Press the CALL button for less than 2 seconds The Home Hub TeleStation should beep For some Home Hubs you may need to use a pen or other pointed object to depress the CALL button Release the CALL button In 10 seconds the using phone light should turn on and the Home Hub TeleStation will dial your healthcare provider After a few minutes the using phone light and the data holding results ligh...

Страница 81: ...es for it to turn off However your special phone service may be interfering with the Home Hub TeleStation If the data holding results light stays on there is probably not a conflict with your special phone service However there may be a problem with your phone line or your healthcare provider s connection If the results above suggest a problem contact your healthcare provider Problem Reason Possib...

Страница 82: ...l jack Use a towel to dry off the Home Hub TeleStation paying special attention to connection points Wait 3 hours for the unit to completely dry Plug the connection cords back into the Home Hub TeleStation and the electrical and phone lines Make sure they snap into place Pick up your telephone receiver and listen for a dial tone If you do not hear a dial tone hang up and try again If you still do ...

Страница 83: ...s you hear the voice prompt Err 4 appears on the display and it says The maximum weight was exceeded Your may have exceeded the maximums weight of 440 lbs 200 kgs Use a regular scale to see if your weight exceeded 440 lbs 200 Kg No voice prompt when you stand on the Scale and it is not set to 0 The Scale s batteries are low Replace all 4 batteries in the Scale as described in Chapter 3 The display...

Страница 84: ...display You moved during the weight measurement Take your weight again and remain still during the measurement Err 5 appears on the display The Scale was unable to read the measurement Use a regular scale to see if your weight exceeded 365 lbs 166 Kg Err 6 appears on the display You did not step off the Scale when prompted Take your weight again and when the Step Off light and voice prompt occur s...

Страница 85: ...rd flat surface and take your weight again If this does not resolve the problem contact your healthcare provider Problem Reason Possible Solutions Problem Reason Possible Solutions Poor heart rhythm measurement or the Home Hub TeleStation is not receiving the heart rhythm measurement The wrist bands are too loose or not properly positioned Push the wristbands up you arms until there is a smooth sn...

Страница 86: ... back in pushing and twisting until it snaps into place appears on the display You moved during the reading Take your blood pressure again remaining very still during the reading appears on the display The pressure measurement did not increase during cuff inflation or the cuff is not securely fastened Check that the air hose is properly connected to the BP Monitor and cuff by unplugging it and the...

Страница 87: ...remain very still during the measurement Pulse is not detected correctly Repeat the measurement and remain very still during the measurement Systolic and diastolic values are within 10 mmHG of each other Refasten the cuff and repeat the measurement remaining very still during the measurement Pressure value did not increase during inflation Check for air leaks along the tube and around the air sock...

Страница 88: ... condition persists contact your healthcare provider appears on the display and flashes Batteries are too low for the Pulse Oximeter to work properly Replace all 4 batteries following the procedure in Chapter 3 Perform a Radio Test appears on the display along with a rising audio tone after battery replacement Indicates that the batteries are good No action required Proceed with Pulse Oximeter mea...

Страница 89: ... appears on the display and flashes Batteries are too low for the Pulse Oximeter to work properly Replace all 4 batteries following the procedure in Chapter 3 Perform a Radio Test appears on the display during start up and after battery replacement Indicates that the batteries are good No action required Proceed with Pulse Oximeter measurement No Pulse rate appears on the display after a measureme...

Страница 90: ...5 3 Standard Scale 5 4 Steady Scale 5 5 Blood Pressure Monitor 5 6 Rhythm Strip Recorder 5 7 Pulse Oximeter 5 7 Technical Specifications 5 9 Physical 5 9 Electrical 5 9 Environmental 5 10 Electromagnetic Compatibility except M3813B and M3815B 5 11 Emissions and Immunity 5 12 Avoiding Electro magnetic Interference 5 12 Avoiding Static Electrical Discharges 5 13 Electromagnetic Compatibility M3813B ...

Страница 91: ...d transmit medical information such as weight blood pressure including pulse rate and non diagnostic ECG rhythm strip to the healthcare provider at another location The patient takes these measurements typically once per day and the information is transmitted automatically via normal telephone time to the healthcare provider The device does not send any real time alarms Clinical judgement and expe...

Страница 92: ...elemonitoring Set devices including physical electrical and environmental Description Home Hub TeleStation Model M3812A Type Class II equipment continuous operation Display LED panel Ports Serial Modem Model M3812B Type Class II equipment continuous operation Display LCD panel Ports Serial Modem All manuals and user guides at all guides com ...

Страница 93: ...ice readout of weight prompts and 4 settings Measurement Range 66 to 440lbs 30 to 200 kg Accuracya a Scale accuracy testing was performed on polyester carpet with a weight of 80 oz twist of 4 8 x 3 3 and density of 4 000 A standard 8 lb pad was used as underlayment 0 5 of loading at maximum patient weight 2 2 lbs 1 0 kg Display Units pounds lbs or kilograms kg user selectable Maximum Allowed Weigh...

Страница 94: ...isplayed and announced simultaneously Language English only Audio Volume Voice readout of weight prompts and 4 settings Measurement Range 66 to 365lbs 30 to 166 kg Accuracy 1 of loading 1 1 lbs 0 5 kg at maximum patient weight 4 8 lbs 2 2 kg Display Units pounds lbs or kilograms kg user selectable Maximum Allowed Weight 365 lbs 166 kg Grab Bar and Post Removable attachment All manuals and user gui...

Страница 95: ... or 3 mm Hg Pressurization Automatic using micropump Depressurization Constant air release valve system Deflation Automatic exhaust Model M3815B Type Type B applied part oscillometric Internally powered continuous operation Display Digital 0 79 in 20 mm character height Pressure and pulse displayed simultaneously Measurement Range Pressure 20 to 280 mm Hg Pulse 40 to 200 pulses per minute Accuracy...

Страница 96: ...ulse displayed alternately SpO2 display range 0 100 Measurement Range SpO2 70 100 functional hemoglobin Pulse rate 18 to 300 beats per minute Measurement Accuracy SpO2 70 100 2 digits 1 Standard Deviation a statistical measure SpO2 calibration range 70 100 determined by arterial blood measurement on a Co oximeter Test methods available upon request Pulse rate 3 1 digit Measurement Wavelengths 660 ...

Страница 97: ...nuous monitoring Display SpO2 displayed in top window 0 75 inches character height Pulse rate displayed in bottom window 0 5 inches character height Measurement Range SpO2 70 to 100 functional oxygen saturation of arterial hemoglobin Pulse 30 to 250 beats per minute Measurement Accuracy SpO2 70 to 100 3 Note the SpO2 calibration range of 70 to 100 was determined by arterial blood measurement on a ...

Страница 98: ...6 5 11 2 4 4 0 34 0 75 b Pulse Oximeter M3814A 6 9 2 7 16 5 6 5 11 2 4 4 037 0 81 b M3814B 6 2 2 4 16 3 6 4 11 2 4 4 0 35 0 77 a Net weight without power module b Net weight with batteries Philips Device Product Part Power Source Battery Life Home Hub M3812A 9 0VAC 500mA Use Philips supplied power adapter only n a TeleStation M3812B Standard Scale M3813B 4 AA 1 5V alkaline batteries connected in s...

Страница 99: ... are present Temperature Atmospheric Pressure Altitude Relative Humidity Philips Device Product Part Operating Storage Operating and Storage hPa Operating and Storage hPa Non condensing Home Hub M3812A 10 40o C 50 104o F 9 54o C 15 130o F 572 1013 0 4600m 0 15 000ft less than 85 TeleStation M3812B Standard Scale M3813B Steady Scale M3813A Blood Pressure Monitor M3815A M3815B Rhythm Strip Recorder ...

Страница 100: ...medical device standards EN 60601 1 2 These EMC standards describe tests for both emitted and received interference Emission tests deal with interference generated by the device itself whereas Immunity tests deal with determining electromagnetic compatibility of the device while used in the presence of surrounding electronic equipment or other external sources that may generate interference Warnin...

Страница 101: ...ded by electromagnetic interference Avoiding Electro magnetic Interference The Philips Telemonitoring System is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the Philips Telemonitoring System can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications ...

Страница 102: ... Telemonitoring Set devices to the Home Hub or TeleStation has less distance to travel and interfering radio signals have less effect The radio transmission from the Philips Telemonitoring Set devices is repeated periodically so that an intermittent source of interference should only delay reception Avoiding Static Electrical Discharges Static discharges to Philips Telemonitoring Set devices may c...

Страница 103: ...01 Radio frequency RF interference from nearby transmitting devices can degrade performance of the electronic equipment Electromagnetic compatibility with surrounding devices should be assessed prior to using the equipment Fixed portable and mobile radio frequency communications equipment can also affect the performance of electronic equipment See your Service Provider for assistance with the mini...

Страница 104: ...the source as much as possible If assistance is needed contact your local Service Provider Note The M3813B and M3815B are intended for use in the electromagnetic environment specified above The customer or the user of these devices should assure that it is used in such an environment Electromagnetic Emissions M3813B and M3815B Emissions Test Compliance Electromagnetic Environment Guidance RF emiss...

Страница 105: ...V for power supply lines 1 kV for input output lines Not Applicable Surge IEC 61000 4 5 1 kV differential mode 2 kV common mode Not Applicable Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 5 UT 95 dip in UT for 0 5 cycle 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip in UT for 25 cycles 5 UT 95 dip in UT for 5 sec Not Applicable Power frequency 50...

Страница 106: ...e equation applicable to the frequency of the transmitter Recommended Separation Distance Radiated RF IEC 61000 4 3 3 V m 80 MHz to 2 5 GHz 3 V m 80 MHz to 800 MHz 800 MHz to 2 5 GHz where P is the maximum output power rating of the transmitter in watts W according to the transmitter s specified output power and d is the recommended separation distance in meters m Field strengths from fixed RF tra...

Страница 107: ...dcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength at the location in which the M3813B Scale or M3815B Blood Pressure Monitor are used exceeds the applicable RF compliance level above the device should be observed to verify no...

Страница 108: ...uation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter s manufacturer Note At 80 MHz and 800 MHz the higher frequency range applies These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people All manuals an...

Страница 109: ...equipment causes interference to radio or television reception which can be determined by turning the equipment off and on the user is encouraged to try to correct it by relocating the Home Hub or TeleStation increasing the separation between the Philips Telemonitoring Set devices or the Home Hub or TeleStation and the device being interfered with for example a TV consulting your healthcare provid...

Страница 110: ... that contains among other information a product identifier in the format US AAAEQ TXXXXX For products approved after July 23 2001 the digits in the product identifier represented by are the REN without a decimal point for example 03 is a REN of 0 3 If requested this number must be provided to the telephone company The REN is useful to determine the number of devices you can connect to your teleph...

Страница 111: ...ent operations or procedures where such action is required in the operation of its business and not consistent with FCC Rules and Regulations If these changes are expected to affect the use or performance of your Home Hub or TeleStation the telephone company must give you adequate notice in writing to allow you to maintain uninterrupted service A plug and jack used to connect the TeleStation must ...

Страница 112: ... Koninklijke Philips Electronics N V Part Number M3810 90096 Issue 5 Printed in the U S A October 2008 M3810 90096 All manuals and user guides at all guides com ...

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