USER GUIDE Blood Pressure Monitor NS-BPMW1 California Residents WARNING: Reproductive harm www.p65warnings.ca.gov Before using your new product, please read these instructions to prevent any damage.
Contents Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 Indications for use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 Measurement principle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 Important Safety Instructions . . . . . . . . . . . . . . . . . . . . . . . 3 Features. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10 Front . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Blood Pressure Monitor Introduction Congratulations on the purchase of your new Insignia Blood Pressure Monitor. Your blood pressure monitor features the latest in design and capabilities and will provide reliable and trouble-free performance. Indications for use This blood pressure monitor is a digital monitor intended for use in measuring blood pressure and heartbeat rate on persons with an arm circumference ranging from approximately 8.75” to 16.5” (22 cm to 42 cm). It is intended for adult use only.
NS-BPMW1 • The device is not intended for patient transport outside a healthcare facility. • The device is not intended for public use. • This device is intended for non-invasive measuring and monitoring of arterial blood pressure. It is not intended for use on extremities other than the arm or for functions other than obtaining a blood pressure measurement. • Do not confuse self-monitoring with self-diagnosis. This unit allows you to monitor your blood pressure.
Blood Pressure Monitor • On the rare occasion of a fault causing the cuff to remain fully inflated during measurement, open the cuff immediately. Prolonged high pressure (cuff pressure >300 mm Hg or constant pressure >15 mm Hg for more than three minutes) applied to the arm may lead to an ecchymosis. • Please check that operation of the device does not result in prolonged impairment of the patient’s blood circulation. • When measuring, please avoid compression or restriction of the connection tubing.
NS-BPMW1 • The patient can measure, transmit data, and change batteries under normal circumstances and maintain the device and its accessories according to the accompanying documents. • To avoid measurement errors, please avoid strong electromagnetic fields, radiated interference signals, or electrical fast transient/burst signals. • The blood pressure monitor and the cuff are suitable for use within the patient environment. If you are allergic to polyester, nylon, or plastic, please don't use this device.
Blood Pressure Monitor • The plug/adapter plug pins insulates the device from the main supply. Do not position the device in a position where it is difficult to disconnect from the electrical outlet to safely terminate operation of ME equipment. • The operator shall not touch output of batteries/adapter and the patient simultaneously. • Cleaning: A dusty environment may affect the performance of the unit. Please use the soft cloth to clean the whole unit before and after use.
NS-BPMW1 • There are no luer lock connectors used in the construction of tubing. There is a possibility that they might be inadvertently connected to intravascular fluid systems, allowing air to be pumped into a blood vessel. • Please use the device under the environment which was provided in the accompanying documents. Otherwise, the performance and lifetime of the device will be impacted and reduced. Contraindications • The device should not be used by any person who may be or is pregnant.
Blood Pressure Monitor Symbol for “ENVIRONMENT PROTECTION - Electrical waste products should not be disposed of with household waste. Please recycle where facilities exist. Check with your local authority or retailer for recycling advice.” Symbol for “RECYCLE.” www.insigniaproducts.
NS-BPMW1 Features • • • • Blood Pressure Monitor Cuff AAA batteries (4) User Guide Front Cuff Air hose Air connector plug Swith user button DC power jack Memory button Set button Start/Stop button LCD display Back Battery compartment 10 www.insigniaproducts.
Blood Pressure Monitor Display # 1 ITEM DESCRIPTION Memory Shows that the monitor is in the memory mode and which group of memory it is. 2 User A Recording measurements for User A. 3 User B Recording measurements for User B. 4 Average value The average value of the latest three records. 5 Low battery Batteries are low and need to be replaced. 6 Heartbeat Blood pressure monitor is detecting a heartbeat during measurement.
NS-BPMW1 # 7 ITEM DESCRIPTION Inflation/ Deflation Current The cuff is inflating or deflating. Shows the date (year, month, day) and time of measurements. 8 time 9 Blood pressure level 10 Systolic Shows your heart’s systolic pressure. blood pressure 11 12 kPa mmHg Indicates the blood pressure level. Blood pressure is displayed in kilopascals (kPa). Blood pressure is displayed in millimeters of mercury (mmHg). 13 Diastolic Shows your heart’s diasoltic pressure.
Blood Pressure Monitor What is the standard blood pressure classification? The chart on the right is the standard blood pressure classification published by American Heart Association (AHA): BLOOD PRESSURE CATEGORY DIASTOLIC MMHG (LOWER #) SYSTOLIC MMHG (UPPER #) Normal Less than 120 and Less than 80 Elevated 120–129 and Less than 80 High blood pressure (hypertension) stage 1 130–139 or 80–89 High blood pressure (hypertension) stage 2 140 or higher or 90 or higher Hypertensive crisis (co
NS-BPMW1 • You have four or more pulse intervals and the difference between each interval and the average is more than the average value of ±15% CAUTION: The appearance of the irregular heartbeat symbol indicates that a pulse irregularity consistent with an irregular heartbeat was detected during measurement. Usually this is NOT a cause for concern. However, if the symbol appears often, seek medical advice.
Blood Pressure Monitor Setting up your blood pressure monitor Powering your blood pressure monitor Your blood pressure monitor can be powered with either batteries (included) or the AC adapter (not included). CAUTION: For the best results and to protect your monitor, use the the correct batteries or a power adapter (not included). Installing the batteries Replace the batteries whenever the low battery indicator ( shown or if the display is dim or doesn’t light up.
NS-BPMW1 Connecting an AC adapter (not included) 1 Make sure that your adapter meets the following requirements: • Input: AC 100–240 V, 50/60 Hz, 0.2 A max Output: 6 V, 1 A 2 Connect the AC adapter from the monitor’s DC power jack to a power outlet. Attaching the cuff to the monitor Connect the cuff’s air hose to the air connector plug on the side of the monitor.
Blood Pressure Monitor 3 Press MEM repeatedly to change the year, then press SET to save your selection. Each press increases the year by one, cycling from 2018–2058. 4 When you get the right year, press SET to save the year. The display shows the date (month/day) settings. 5 Press MEM repeatedly to change the month, then press SET to save your selection. Each press increases the month by one, cycling from 1–12 (January–December).
NS-BPMW1 8 Press MEM repeatedly to change the hour, then press SET to save your selection. Each press increases the hour by one, cycling from 1–12 (if you selected 12h) or 0–23 (if you selected 24h). 9 Press MEM repeatedly to change the minutes, then press SET to save your selection. Each press increases the minutes by one, cycling from 00–59. 10 Press MEM repeatedly to change the blood pressure unit, then press SET to save your selection. Each press switches between mmHg and kPa.
Blood Pressure Monitor Using your blood pressure monitor Getting accurate measurements Follow these tips for the most accurate readings (especially for people with hypertension): • Rest for five minutes before the first measurement. Relax as much as possible and do not move and talk during the measurement. • Keep the cuff at the same level as the right atrium of the heart. • Sit comfortably with your feet flat on the ground. Do not cross your legs. • Keep your back against the backrest of the chair.
NS-BPMW1 4 Position the tube off-center toward the inner side of your arm (in-line with the little finger). OR Position the artery mark ( ) over the main artery on the inside of your arm. Note: To locate the main artery, press two fingers approximately .8 in. (2 cm) above the bend of your elbow on the inside of your left arm. Identify where the pulse can be felt the strongest. This is your main artery. Positioning in-line with little finger Positioning with the artery mark .8–1.2 in.
Blood Pressure Monitor Taking your measurements WARNING: • This monitor is not suitable for measuring children. • If you need to stop the cuff from inflating, press START/STOP to immediately release the air. Loosen the cuff and remove it from your arm. • Read all ”Important Safety Instructions” on page 3 before using this monitor. www.insigniaproducts.
NS-BPMW1 1 When the monitor is off, press the START/STOP to turn on the monitor. The monitor takes your measurements and saves the data for the selected user. user button Note: You can select user A or B by pressing the during measurement or when in the memory mode. Monitor turns on Adjusting the zero point Inflating and measuring Displays and saves measurement 2 Press the START/STOP to turn off the monitor, or it will turn off within one minute. 22 www.insigniaproducts.
Blood Pressure Monitor Recalling records 1 When the monitor is off, press MEM. The monitor cycles through the last three records. If there are less than three records, it will show the latest record instead. Note: The most recent record (1) is shown first. Each new measurement is assigned to the first (1) record. All other records are pushed back one digit (for example, 2 becomes 3, and so on), and the last record (250) is dropped from the list.
NS-BPMW1 Deleting all records If you did not get the correct measurement, you can delete all records for the selected user. You cannot delete a single record. 1 When the monitor is off, press MEM to enter memory recall mode. 2 Press and hold SET for three seconds. “dEL ALL” and the user ID flash on the display. 3 Press SET to confirm that you want to delete all records. “dEL donE” and the user ID are shown, then the monitor turns off.
Blood Pressure Monitor 4 When all records are deleted, the screen shows “- - -.” Press MEM to return to the correct screen. Maintaining your blood pressure monitor In order to get the best performance: • Store in a dry place and avoid the sunshine. • Avoid intense shaking and collisions. • Use a wet or dry cloth to remove dirt on the monitor. • Avoid contact with water. Clean with a a dry cloth. • Avoid dusty and unstable temperature environments. • Do not attempt to clean the reusable cuff with water.
NS-BPMW1 PROBLEM The display says “out.” POSSIBLE SOLUTIONS • Your results are out of measurement range. Take a moment to relax. Refasten the cuff and measure again. If the problem persists, contact your physician. Error messages ERROR CODE POSSIBLE PROBLEM/SOLUTION “E 01” is shown. The cuff is too tight or too loose. Refasten the cuff and measure again. “E 02” is shown. The monitor detected motion, talking, or the pulse is too poor while measuring. Relax for moment, then measure again.
Blood Pressure Monitor Specifications Dimensions (H × W × D) Blood pressure monitor: 2.3 × 5.1 × 5.5 in. (5.9 × 13 × 14 cm) Weight .6 lbs (260 g) Power supply Batteries: 6VDC 4×AAA batteries AC adapter: Input: AC 100–240 V, 50/60 Hz, 0.2 A Max Output: 6 V, 1 A Display mode Digital LCD Measurement mode Oscillographic testing mode Measurement range Rated cuff pressure: 0 mmHg ~ 299 mmHg (0 kPa ~ 39.9 kPa) Measurement pressure: SYS: 60 mmHg ~ 230 mmHg (8.0 kPa ~ 30.
NS-BPMW1 Mode of operation Continuous operation Degree of protection Type BF applied part Protection IP21 against ingress (The device is protected against solid foreign objects of of water .5 in. (12.5 mm) and greater and is protected against vertically falling water drops.
Blood Pressure Monitor General requirements for safety • EN 60601-1:2006+A1:2013/ IEC 60601-1:2005+A1:2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance • EN 60601-1-11:2015/ IEC 60601-1-11:2015 Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment Electomagne
NS-BPMW1 Usability • EN 60601-1-6:2010+A1:2015/IEC 60601-1-6:2010+A1:2013 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability • IEC 62366-1:2015 Medical devices - Part 1: Application of usability engineering to medical devices Software life-cycle processes • EN 62304:2006/AC: 2008 / IEC 62304: 2006+A1:2015 Medical device software - Software life-cycle processes Biocompatibility • ISO 10993-1:2009 Biological evaluatio
Blood Pressure Monitor • Warning: Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 12 in. (30 cm) to any part of the equipment NS-BPMW1, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.
NS-BPMW1 Table 2 GUIDANCE AND MANUFACTURER’S DECLARATION – ELECTROMAGNETIC IMMUNITY IMMUNITY TEST IEC 60601-1-2 TEST LEVEL COMPLIANCE LEVEL Electrostatic discharge ±8 kV contact ±8 kV contact (ESD) ±2 kV, ±4kV, ±8 kV, ±15 ±2 kV, ±4kV, ±8 kV, IEC 61000-4-2 kV air ±15 kV air Electrical fast transient/burst IEC 61000-4-4 ±2 kV for power supply lines ±1 kV signal input/output 100 kHz repetition frequency ±2 kV for power supply lines ±1 kV signal input/output 100 kHz repetition frequency Surge IEC61000-4-
Blood Pressure Monitor GUIDANCE AND MANUFACTURER’S DECLARATION – ELECTROMAGNETIC IMMUNITY IEC 60601-1-2 TEST LEVEL COMPLIANCE LEVEL Conduced RF IEC61000-4-6 3V 0.15 MHz – 80 MHz 6 V in ISM and amateur radio bands between 0.15 MHz and 80 MHz 80% AM at 1 kHz 3V 0.15 MHz – 80 MHz 6 V in ISM and amateur radio bands between 0.15 MHz and 80 MHz 80% AM at 1 kHz Radiated RF IEC61000-4-3 10 V/m 80 MHz – 2.7 GHz 80% AM at 1 kHz 10 V/m 80 MHz – 2.7 GHz 80% AM at 1 kHz IMMUNITY TEST Note: UT is the a.c.
NS-BPMW1 Table 3 GUIDANCE AND MANUFACTURER’S DECLARATION ELECTROMAGNETIC IMMUNITY Radiated RF IEC61000-4-3 (Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless communications equipment). TEST FREBAND SERVICE QUENCY (MHZ) (MHZ) MODULATION MODU- DISLATION TANCE (W) (M) IMMUNITY TEST LEVEL (V/M) 385 380– 390 TETRA 400 Pulse 1.8 modulation b) 18Hz 0.3 27 450 430– 470 GMRS 460, FRS 460 FM c) ± 5kHz deviation 1kHz sine 0.3 28 710 704– 787 LTE Band 13, 17 Pulse 0.
Blood Pressure Monitor GUIDANCE AND MANUFACTURER’S DECLARATION ELECTROMAGNETIC IMMUNITY Radiated RF IEC61000-4-3 (Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless communications equipment). TEST FREBAND SERVICE QUENCY (MHZ) (MHZ) MODULATION MODU- DISLATION TANCE (W) (M) IMMUNITY TEST LEVEL (V/M) 2450 2400– Bluetooth, Pulse 2570 WLAN, 802.11 modulation b/g/n, RFID 217Hz 2450, LTE Band 7 2 0.3 28 5240 5100– WLAN 802.11 Pulse 5800 a/n modulation 217Hz 0.2 0.
NS-BPMW1 FCC Caution Changes or modifications not expressly approved by the party responsible for compliance could void the user's authority to operate this equipment. Note: This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation.
Blood Pressure Monitor ONE-YEAR LIMITED WARRANTY Definitions: The Distributor* of Insignia branded products warrants to you, the original purchaser of this new Insignia-branded product (“Product”), that the Product shall be free of defects in the original manufacturer of the material or workmanship for a period of one (1) year from the date of your purchase of the Product (“Warranty Period”).
NS-BPMW1 What does the warranty not cover? This warranty does not cover: • Customer instruction/education • Installation • Set up adjustments • Cosmetic damage • Damage due to weather, lightning, and other acts of God, such as power surges • Accidental damage • Misuse • Abuse • Negligence • Commercial purposes/use, including but not limited to use in a place of business or in communal areas of a multiple dwelling condominium or apartment complex, or otherwise used in a place of other than a private home.
Blood Pressure Monitor FITNESS FOR A PARTICULAR PURPOSE, ARE LIMITED IN DURATION TO THE WARRANTY PERIOD SET FORTH ABOVE AND NO WARRANTIES, WHETHER EXPRESS OR IMPLIED, WILL APPLY AFTER THE WARRANTY PERIOD. SOME STATES, PROVINCES AND JURISDICTIONS DO NOT ALLOW LIMITATIONS ON HOW LONG AN IMPLIED WARRANTY LASTS, SO THE ABOVE LIMITATION MAY NOT APPLY TO YOU. THIS WARRANTY GIVES YOU SPECIFIC LEGAL RIGHTS, AND YOU MAY ALSO HAVE OTHER RIGHTS, WHICH VARY FROM STATE TO STATE OR PROVINCE TO PROVINCE.
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