Digital Blood Pressure Monitor Instructions for Use CAUTION: Federal law restricts this device to sale by or on the order of a physician or licensed healthcare provider
Table of Contents A Special Thank You..............................................................................................4 Introduction ..........................................................................................................4 Intended Use ..........................................................................................................4 Pregnancy ..............................................................................................................
Viewing the stored values ......................................................................................26 Rechargeable Battery and Power Adapter ........................................................27 Using the Power Adapter........................................................................................27 Rechargeable Battery ............................................................................................27 Troubleshooting .....................................................
A Special Thank You Thank you for choosing an ADC blood pressure device. We’re proud of the care and quality that goes into the manufacture of each and every item that bears our name. Only the finest materials are used to assure you of a timeless device designed for optimum performance. You’ll quickly appreciate the results, for you now own one of the finest noninvasive blood pressure monitors that money can buy.
Pregnancy Approximately 20% of women develop hypertension during pregnancy (preeclampsia or toxemia). Preeclampsia can usually be recognized by a clear increase in blood pressure and high urine protein levels after 20 weeks of gestation. Since many oscillometric devices appeared to be unsuitable for use in pregnancy, preeclampsia health care authorities require that blood pressure monitors used for this vulnerable patient group are specifically tested.
Warnings and Cautions General warnings and cautions WARNING: The information in these instructions for use provides a comprehensive guide to the operation of the e-sphyg 3. For best results, read thoroughly before using the device. WARNING: The device is intended for use only in environments with clinician supervision. WARNING: The device is designed for medical clinician use. Only a trained clinician should use this device. WARNING: This device is NOT motion tolerant.
WARNING: The device may not function properly if dropped or damaged. Do not use the device if you notice any signs of damage. Qualified service personnel must check any device that is dropped or damaged for proper operation before putting the device back in to use. WARNING: If the battery shows any signs of damage, leakage, or cracking, it must be replaced immediately and only with a battery recommended for or supplied with the device.
CAUTION: Use only ADC-approved accessories. Use of unapproved accessories with the device can affect patient and operator safety and can reduce product performance and accuracy. CAUTION: Federal law restricts this device to sale by or on the order of a physician or licensed health care provider. NIBP (non-invasive blood pressure) warnings and cautions WARNING: The e-sphyg 3 is not intended to measure blood pressure on children younger than three years of age.
CAUTION: Measurement arm should be at heart level. If the blood pressure cuff is not at heart level, note the difference in reading due to the hydrostatic effect. CAUTION: Proper blood pressure cuff size and placement is essential to the accuracy of the blood pressure determination. See the section on Blood Pressure Cuff Selection for sizing information. CAUTION: The blood pressure cuff must be properly positioned to ensure blood pressure accuracy and patient safety.
Symbols Documentation symbols WARNING: The warning statements in this manual identify conditions or practices that, if not corrected or discontinued immediately, could lead to illness, injury, or death. CAUTION: The caution statements in this manual identify conditions or practices that could result in damage to the equipment or other property, or loss of data. CAUTION: Consult operating instructions for use (IFU), before using.
E-sphyg 3 Components and Accessories 1 X e-sphyg3 Extension Tubing TM Reusable BP Cuff Small Adult 13 T 10 19 - 27 cm 1X Small Adult Cuff (19cm-27cm) TM Reusable BP Cuff 1X Adult Cuff (23cm-40cm) 13 T Adult 11 23 - 40 cm 1X Large Adult Cuff (34cm-50cm) TM Reusable BP Cuff 13 T Large 12 34 - 50 cm Adult 1X Power Adapter 4X Power Plugs (US, Europe, UK, Australia) Input: 100-240V - 50/60Hz 0.5A Output: +7.5V 1.
Parts and Assembly Handle Cuff Socket Extension Tubing On/Off Switch Power Adapter Socket Battery Compartment Recharge Indicator Display Memory Button Mode Switch Start/Stop Button 12
Display Low Battery Power Mode Selection: Single Reading, Manual, Three-Reading Average Unit of Measure Rest/Count Down Maximum Inflation Pressure Auto Inflation Memory Systolic Value 1x 3x SYS mmHg Pa 260 34.7 240 32.0 220 29.3 200 26.7 180 24.0 160 21.3 140 18.
Initial Setup Attach power plug to adapter Select a proper power plug and attach to the power adapter as shown below. Charge the battery When using for the first time, charge the battery until the recharge indicator on the device turns to green. Refer to page 27 for the section of “Using the power adapter.” Refer to page 27 for the section “Rechargeable battery.” Connect the Extension Tubing The e-sphyg 3 comes with a 140 cm (4.
Select the unit of measure Three measurement unit combinations are available: mmHg/MAP, mmHg/PAM, and kPa/MAP. MAP is the abbreviation of Mean Arterial Pressure. PAM or MAP is chosen depending on language preference. The factory default is mmHg/MAP. To change the unit of measure: 1) Make sure the device is switched off. 2) Press and hold the Memory Button and then turn on the power with the On/Off Switch. 3) Release the Memory Button when backlight illuminates.
Choosing the Correct Cuff Your e-sphyg 3 comes standard with three cuffs: Small Adult, Adult, and Large Adult. Limb Range Inches CM Cuff Size Small Adult 10SA 7.4 to 10.6 19 to 27 Adult 11A 9 to 15.7 23 to 40 Large Adult 12X 13.3 to 19.6 34 to 50 ADC’s Size Guide marking system assures use of correct cuff size and proper cuff alignment. Printed Index and Range markings and applicable limb range (in/cm) allow easy identification of the correct cuff size.
Each cuff is provided with 50 cm air tube. Use only cuffs provided by ADC! Contact ADC or an authorized distributor to purchase cuffs. Measurement Procedure Patient position The patient should sit or lie comfortably. The arm should be fully supported on a flat surface at heart level. (If the arm’s position varies, or is not level with the heart, measurement values obtained will not be consistent with the patient’s true blood pressure.
Taking Measurements Turn on the power Turn on the device by moving the On/Off Switch to the ON position. Connect the cuff Connect the cuff to the extension tubing. TM Reusable BP Cuff Adult 11 23 - 40 cm Set maximum inflation pressure Select desired maximum inflation pressure or choose "AUTO". Refer to page 23 for the section on “Set maximum inflation pressure“ Select an operation mode There are three measurement modes.
1x Mode (standard single measurement) Select «1x » Mode then press the Start/Stop Button to perform a single blood pressure measurement. The measurement reading is displayed and saved after the measurement. «Manual» Mode Ad ul t 11 23 -4 0c Re us ab le m BP Cu ff TM T 13 Select Manual Mode if auscultatory blood pressure measurement is preferred above using the oscillometric method. In «Manual» Mode, the device serves only as a pressure gauge. No oscillometric measurements will be taken.
Ad ult 11 23 - 40 Re us ab le cm BP Cu ff TM T 13 Start inflation – Press the Start/Stop Button to begin inflation. When maximum inflation pressure is reached, the e-sphyg 3 will automatically begin linear deflation at a rate of 3 mmHg/sec. Re-inflate – Push and Hold the Memory Button during deflation to re-inflate for as long as the button is held (up to a max of 299 mmHg). Release the button to continue deflation.
«3x» Mode (automatic three-reading average) Select «3x» Mode then press the Start/Stop Button to perform on automatic three-reading average. The countdown time before the first measurement is set at 60 seconds. The interval times between measurements is user adjustable to 15, 30, 45, or 60 seconds. The average measurement reading is displayed and saved after all three measurements are complete. The user can manually select measurement interval times of 15, 30, 45 or 60 seconds in «3x» Mode.
Special Features MAP (mean arterial pressure) The e-sphyg 3 measures the patient’s true mean arterial pressure (MAP). Each measurement includes a single MAP value. The MAP value will always be displayed together with the systolic and diastolic blood pressure value. MAP MAP is determined from the maximum peak of the oscillometric envelope curve. Irregular heartbeat detector in «1x » Mode The device detects irregular heartbeat in «1x» Mode.
Setting maximum inflation pressure 1) Press and hold the Memory Button for three seconds until the column with pressure values flashes. 2) Press the Start/Stop Button to select the preferred pressure value (after value “260” has been reached the selector will return to “AUTO” at the bottom of the list). 3) Press the Memory Button to confirm the selected value. Push and hold for 3 seconds... The inflation pressure selection (mmHg/kPa) can be done in «1x», « 3x », or Manual Mode. The default setting is “AUTO.
Taking fewer than three measurements in « 3x » Mode The measurement sequence can be stopped at any time by pressing the Start/Stop Button. The device enters standby and remaining measurements are cancelled. Data from the measured blood pressure can be viewed by pushing the Memory Button. Cancel remaining measurements at any time during the measurement sequence.
Setting measurement interval times in « 3x » Mode The default measurement interval time is 60 seconds. The interval times can be set as 15, 30, 45, or 60 seconds. 1) Press and hold the Start/Stop Button for three seconds. Push and hold for 3 seconds... 2) Press the Memory Button to adjust the measurement interval time, then press the Start/Stop Button to confirm. The device will go back to standby. Interval times can be set to 15, 30, 45, or 60 seconds.
Viewing the stored values The device stores blood pressure values of the last measurement procedure in «1x» and «3x» Mode. Press the Memory Button to review the stored readings when the device is in standby mode. In «1x» Mode In « 3x » Mode Press the Memory Button to reveal the average of the triple measurements. Continue pressing the Memory Button to review individual measurements.
Rechargeable Battery and Power Adapter Rechargeable battery The e-sphyg 3 features a built-in, rechargeable Ni-MH battery pack that provides up to 1200 measurement cycles on a full charge. The battery can be recharged with the power adapter provided. The empty battery indicator is displayed when the battery is low. When using for the first time, charge the battery until the recharge indicator turns to green. The orange recharge indicator means that the recharge is in progress.
Troubleshooting Problem No power (No LCD display) Cuff does not inflate properly No result displayed after measurements Possible cause Solutions Power supply is not properly plugged in. Plug the power supply into the wall socket. Battery is fully discharged. Recharge the battery by plugging in the power supply. Loose connection of the tube. Make sure the tube of the cuff is securely connected to the device. Leakage of the tube / bladder. Check for cracks on the tube or the bladder.
«Err 3» No pressure in the cuff An adequate pressure cannot be generated in the cuff. A leak may have occurred. Replace the blood pressure cuff if necessary. Repeat the measurement. «Err 5» No valid results The measuring signals are inaccurate therefore no result can be displayed. Switch to Manual Mode and determine blood pressure with a stethoscope using traditional Korotkoff method.
Safety and Protection This device may be used only for the purpose described in this manual. The device contains sensitive components and must be treated with care. The manufacturer cannot be held liable for damage caused by incorrect application. Only activate the pump when the cuff is connected to the device. Do not use the device if you think it is damaged or if anything appears unusual. Read further safety instructions in the individual sections of the instruction manual.
Cleaning the Unit Use a soft cloth with one of the following recommended cleaning solutions to wipe the exterior of the device: 1) Mild soap and water 2) Hydrogen peroxide solution (3% diluted with water) 3) Sodium hypochlorite solution (1:10 dilution of household chloride bleach in water) Cleaning the Cuff Adcuff (Two-piece design): Remove the bladder. Fold and place the cuff cover inside a washing bag. Wash the cuff cover with warm water (43°C; 110°F) and a mild detergent in the washing machine.
Calibration We recommend the device be tested for accuracy every two years or after mechanical impact (e.g., been dropped). 1) Set up for accuracy test: Calibrated reference manometer Squeeze bulb (or pressure source) 2) Push and hold Start/Stop Button, turn the power on, then release the Start/Stop Button. A series of codes will flash on screen, then “0.0” will display.
3) Pump the pressure to nearly 100 mmHg. Compare the pressure displayed on the screens of the device and the reference manometer. For example, the “100 .9” displayed on the device stands for “100.9 mmHg.” 4) Pump the pressure to nearly 200 mmHg. Compare the pressure displayed on the screens of the device and the reference manometer. For example, the “201.0” displayed on the device stands for “201.0 mmHg.” 5) Pump the pressure to nearly 300 mmHg.
Technical Specifications Operation temperature/humidity: 50°F to 104°F (10°C to 40°C) 15 - 90% relative maximum humidity Storage temperature/humidity: -4°F to 131°F (-20°C to 55°C) 15 - 90% relative maximum humidity Weight: 2.08 lbs (942 g) (including rechargeable battery pack) Dimensions: 7.87'' x 4.92'' x 3.54'' (20 x 12.
Annex of Report Manufacturer’s Declaration of the EUT Issued: 2014-12-15 A2 Report No.: TRE14120020 Guidance and manufacturer’s declaration – electromagnetic emission – for all EQUIPMENT AND SYSTEMS 1 Guidelines and manufacturer's declaration - electromagnetic emissions 2 The e-sphyg 3 Digital Blood Pressure Monitor is intended for use in the electromagnetic environment specified below. The customer or the user of e-sphyg 3 Blood Pressure Monitor should assure that it is used in such an environment.
Guidance and manufacturer’s declaration – electromagnetic immunity – for EQUIPMENT and SYSTEM that are not LIFE-SUPPORTING Guidance and manufacturer’s declaration – electromagnetic immunity The e-sphyg 3 Digital Blood Pressure Monitor is intended for use in the electromagnetic environment specified below. The customer or the user of the e-sphyg 3 Digital Blood Pressure Monitor should assure that it is used in such an environment.
Warranty Please register your e-sphyg 3 online at: http://www.adctoday.com/register. ADC warrants its products against defects in materials and workmanship under normal use and service as follows: Your e-sphyg 3 and Adcuffs are warranted for three years. The battery is warranted for one year. Accessories are warranted for one year. Warranty service extends to the original retail purchaser only and commences with the date of delivery. What Is Covered: Replacement of parts and labor.
Onbo Electronic (Shenzhen) Co., Ltd No. 138 Huasheng Road Langkou Community, Dalang Street Longhua District, Shenzhen Microlife AG Espenstrasse 139 9443 Widnau, Switzerland 38 Dist. By: ADC 55 Commerce Drive Hauppauge, NY 11788 www.adctoday.com email: info@adctoday.
