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2 TABLE OF CONTENTS Introduction...1 Features...1 Indications for Use...1 Contraindications...1 Warnings & Precautions...2 Controls...3 Operation...4 Recharging the Battery...5 Replacing the Battery...5 Symbols...5 Specifications...6 Cleaning & Maintenance...7 Warranty...7 Safety Standards

3 Thank you for purchasing the FAST Sphyg by Koven This operation manual is intended to assist you to safely and efficiently operate your new FAST Sphyg aneroid sphygmomanometer. The FAST Sphyg is to be used with a stethoscope or Doppler and an appropriate sized vascular cuff. Please read this manual carefully to acquaint yourself with the proper operation. FEATURES Push button inflation User controlled deflation Works with all types of vascular cuffs Rechargeable battery INDICATIONS FOR USE The FAST is a sphygmomanometer intended to be used with a stethoscope or Doppler for indirect measurement of arterial blood pressure. This FAST sphyg includes an aneroid gauge. Koven Technology, Inc. intends to provide the FAST sphyg for use by healthcare providers. Our products are for both hospital and clinical use and are intended for pediatric through adults, excluding neonates. CONTRAINDICATIONS Safety and effectiveness with neonate cuff sizes 1 through 5 is not established. 1

4 WARNINGS & PRECAUTIONS Please read the following important points before using the FAST Sphyg: WARNING: Do not leave the blood pressure cuff on the patient for more than 10 minutes when inflated above 10 mmhg. This may cause patient distress, disturb blood circulation, and contribute to the injury of peripheral nerves. WARNING: Do not apply the cuff to delicate or damaged skin. Check cuff site frequently for irritation. WARNING: Do not apply the cuff to limbs used for IV infusion. WARNING: If luer lock connectors are used in the construction of tubing, there is a possibility that they might be inadvertently connected to intra-vascular fluid systems, allowing air to be pumped into a blood vessel. Immediately consult a physician if this occurs. WARNING: Replacement of the lithium-ion battery by inadequately trained personnel could result in personal injury. WARNING: Cuffs should be placed snugly but not tight. WARNING: Incremental inflation beyond 270 mmhg is possible when using small cuffs. WARNING: If modifications are performed to this device, appropriate inspection and testing must be conducted to ensure its continued safe use. WARNING: Use only the Koven AC Charger provided. Other chargers may damage the battery. PRECAUTION: Use the proper cuff size. Use of improper cuff sizes may result in erroneous readings. PRECAUTION: The patient should remain still during measurement to avoid erroneous readings. PRECAUTION: Do not submerge the FAST Sphyg in any liquid. PRECAUTION: The FAST Sphyg is designed for use with one tube systems. PRECAUTION: Do not apply excessive pressure when connecting the tube connector into the port. This could cause damage to the device. PRECAUTION: Extreme altitudes may affect blood pressure readings. This device has been designed for normal environmental conditions. PRECAUTION: This product will maintain the safety and performance characteristics specified at temperatures ranging from 32 F to 104 F (0 C to 40 C) at a relative humidity level of 15% to 85%. To obtain the greatest accuracy, it is recommended that this device be used within a temperature range of 50 F (10 C) to 104 F (40 C) with a relative humidity of 15% to 85% (non-condensing). PRECAUTION: Do not drop from a height of over 25 cm. Doing so may cause damage to the unit or affect calibration. PRECAUTION: The device should not be used in out-of-hospital transportation of patients. CAUTION: The FAST Sphyg has not been evaluated for safety and compatibility in the MR environment. The FAST Sphyg has not been tested for heating or migration in the MR environment. 2

5 CONTROLS Gauge Face Trigger Valve Actuator Button Tubing Connector Port Battery Status Indicator DC Jack AC Charger Strap Connector Displays the pressure reading in mmhg To deflate the cuff To inflate the cuff To connect extender tubing To indicate battery charge status Blue LED: Charging battery with AC charger Blue LED blinking: Low battery LED off: Not charging battery (see Recharging the Battery for details) To plug in the AC charger To recharge the battery To connect the wrist strap 3

6 OPERATION 1. Ask the patient to sit or lie comfortably with legs uncrossed. Make sure the arm is level with the heart and that the arm and back are supported. The patient should relax comfortably for five (5) minutes before testing and should be instructed not to talk or move during the measurement. 2. Wrap a properly sized pressure cuff, comfortably snug around the patient s bare limb or digit. Arm cuffs should be positioned with the middle of the cuff on the upper arm at heart level. NOTE: For correct cuff sizing, refer to your cuff manufacturer s guidelines. 3. Use extender tubing to connect the sphyg to the cuff. Insert the tubing connector and twist clockwise to secure to the sphygmomanometer. When properly attached, less than 1/16 of connector shaft will remain visible. 4. Apply a Doppler probe or stethoscope to the artery and listen for steady pulse sounds. NOTE: Before inflating the cuff, be sure the trigger valve lock mechanism is released. 5. Press the actuator button to begin cuff inflation. There will be a slight delay before inflation begins. This allows the device to determine the proper cuff size. However, there will be no delay if using a digit cuff. Keep the actuator button depressed until the desired pressure is obtained. To avoid parallax error, the operator should view the guage face in a direct line. The cuff should be inflated approximately 20 mmhg past the point where waveform motion and/or sound ceases (K5). Release the button to stop cuff inflation. Press the actuator button again to continue inflation. NOTE: In children ages 3-12, inflate the cuff until sound is muffled (K4). K5 should be used for pregnant female patients, unless sounds are audible when the cuff is deflated, in which case K4 should be used. 6. Gradually deflate the cuff at a rate of 2-3 mmhg per second by pressing down on the trigger until sound and/or waveform motion returns. NOTE: Altering the pressure applied to the trigger valve during deflation affects the deflation rate. 7. The point where sounds and/or waveform motion returns is the systolic pressure. Note the millimeters of mercury reading at the point where sounds and/or waveform motion ceases. This is the diastolic pressure. 8. After measurement is complete, open the trigger valve fully to release any remaining air in the cuff. Disconnect the tubing from the cuff by twisting the connector counterclockwise. NOTE: For rapid deflation, squeeze the trigger valve until it clicks and locks into place. 4

7 RECHARGING THE BATTERY This device uses a rechargeable Lithium-Ion battery. When the battery is low, the battery status indicator light will start to flash blue. To recharge the battery, connect the AC charger to the DC connection port on the bottom of the unit and plug into a wall outlet. The battery status indicator light will turn solid blue while charging is in process. When charging is complete the battery indicator light will shut off. Unplug before use. NOTE: It takes approximately 1 hour to fully recharge the battery. NOTE: The device will not operate while plugged in. REPLACING THE BATTERY Average battery life is approximately 2 years. Battery replacement should only be performed by the manufacturer. For battery replacement, please contact Koven Technology, Inc. at or info@koven.com. SYMBOLS Symbol Description Symbol Description Caution Latex Free Manufacturer Temperature Limit Date of Manufacture Humidity Limit Authorized European Representative Type B Applied Part AC Charger Connector ON/OFF Push Button Follow Operating Instructions Lot Number Symbol for the marking of electrical and electronics devices according to Directive 2002/96/EC. The device, accessories & packaging must to be disposed of correctly at the end of the usage. Please follow local ordinances or regulations for disposal. Class II Device 5

8 SPECIFICATIONS Nominal Pressure Range: mmhg Pressure Accuracy: ± 3 mmhg Max. Air Leakage Rate: 4 mmhg / minute Power: Rechargeable Li-ion Battery Voltage: 3.7 Volts Battery Life (before recharge): Approx. 250 readings AC Charger: Input Voltage: 100 to 240 Vac. Output Voltage: DC5V, 1.2A Inflation Speed: Variable Environmental Temperature Range: Operation: 10 to 40 C Storage/Transport: -20 C to 55 C Relative Humidity Range: Operation: 15 to 85% (non-condensing) Storage/Transport: 90% Dimensions: 216 (L) x 76 (W) x 89 (H) mm Dial Face: 49 mm (Diam.) Weight: 310 grams Electrical safety: Conforms to IEC Class II equipment Internally powered equipment Type B applied part Conforms to Directive 2011/65/EU on the restriction of the use of certain hazardous substances in electrical and electronic equipment Shock proof: Retains calibration for drops under 25 cm Not made with natural rubber latex * Specifications are subject to change INCLUDES: FAST Aneroid Sphygmomanometer AC Charger (1), Wrist Strap (1), Male Luer Connector (1) 6

9 CLEANING & MAINTENANCE The FAST Sphyg can be wiped down using warm water, enzymatic cleaner, or alcohol with a damp soft cloth after use. If an enzymatic cleaner is used, wipe down again using warm water or alcohol with a damp soft cloth. Hospital approved alcohol based wipes are an acceptable alternative to a damp soft cloth. CAUTION: Do not submerge the FAST Sphyg in any liquid. DO NOT DISMANTLE. Gauge accuracy can be checked visually by verifying that the needle rests within the printed oval (figure 1) when the unit is fully deflated. If the indicator needle rests outside of the calibration mark, the sphygmomanometer is out of calibration, and must be re-calibrated to within ±3 mmhg when compared to a reference device that has been certified to national or international measurement standards. Call Koven Technology service if you have a sphyg in need or calibration or for any calibration questions. figure 1 No sphygmomanometer that has the indicator needle resting outside of this mark is acceptable for use. QUALITY CONTROL A Serial Number and Lot number are automatically assigned to every FAST Sphyg during manufacturing. The Serial Number is imprinted on the front of the faceplate (see figure 2). The Lot number is located on the outside package label and is designated with the symbol. WARRANTY Serial Number figure 2 This equipment is guaranteed for the period of 1 year after the date of purchase when used under normal conditions. In the event of malfunction during the warranty period, please contact Koven Technology, Inc. at or info@koven.com. The warranty does not cover defects resulting from accidents or misuse and is void if modifications of parts are attempted without permission. If the warranty period has expired, please contact Koven Technology, Inc. for a charged repair service. 7

10 SAFETY STANDARDS The FAST conforms to the following standards: Manufacturing standard: IEC Protection class against electric shock : Class II device : Internally powered equipment Protection grade against electric shock : Type B applied part 2. Guidance and manufacturer s declaration - Electromagnetic emissions & immunity ISO Non-invasive sphygmomanometers Part1: Requirements and test methods for nonautomated measurement type Guidance and Manufacturer s Declarations Electromagnetic Emissions The FAST Sphyg is intended for use in the electromagnetic environment specified below. The user of the FAST Sphyg should assure that it is used in such as environment. Emissions test Compliance Electromagnetic Environment - Guidance RF emissions Group 1 The FAST sphyg uses RF energy only for its internal CISPR 11 function. Therefore, the RF emissions are very low and are not likely to cause interferance in nearby electronic equipment RF emissions Class B CISPR 11 The FAST Sphyg is suitable for use in all establishments, Harmonic Class A including domestic establishments and those directly emissions connected to the public low-voltage power supply network that supplies buildings used for domestic Flicker Not applicable purposes. emissions IEC

11 Guidance and Manufacturer s Declarations (cont.) Electromagnetic Immunity The FAST Sphyg is intended for use in the electromagnetic environment specified below. The user of the FAST Sphyg should assure that it is used in such as environment. Immunity test IEC60601 Test Level Compliance Level Electromagnetic Environment - Guidance Electrostatic ± 6kV contact ± 6kV contact Floors should be wood, Discharge (ESD) ± 8kV air ± 8kV air concrete or ceramic tile. If IEC floors are covered with synthetic material, the relative humidity should be at least 30%. Electrical Fast ± 2kV for power ± 2kV for power Mains power should be that of a Transient/burst supply lines supply lines typical commercial or hospital IEC ± 1kV for input/output ± 1kV for input/output environment. lines lines Surge ± 1kV differential ± 1kV differential Mains power should be that of a IEC mode mode typical commercial or hospital ± 2kV common mode ± 2kV common mode environment. Voltage dips, short < 5% U T < 5% U T interruptions and (> 95% dip in U T ) (> 95% dip in U T ) voltage variations for 0,5 cycles for 0,5 cycles on power supply 40% U T 40% U T input lines (60% dip in U T ) (60% dip in U T ) Mains power should be that of a IEC for 5 cycles for 5 cycles typical commercial or hospital environment. 70% U T 70% U T (30% dip in U T ) (30% dip in U T ) for 25 cycles for 25 cycles < 5% U T < 5% U T (> 95% dip in U T ) (> 95% dip in U T ) for 5 s for 5 s Power frequency 3 A/m 3 A/m Power frequency magnetic (50/60 Hz) fields should be at levels magnetic field characteristic of a typical IEC location in a typical commercial or hospital environment NOTE U T is the a.c. mains voltage prior to application of the test level. 9

12 Guidance and Manufacturer s Declarations (cont.) Electromagnetic Immunity (cont.) The FAST Sphyg is intended for use in the electromagnetic environment specified below. The user of the FAST Sphyg should assure that it is used in such an environment. Immunity test IEC60601 Test Level Compliance Level Electromagnetic Environment - Guidance Portable and mobile RF communications equipment should be used no closer to any part of the FAST Sphyg including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance: Conducted RF 3Vrms 3Vrms d = 1,2 P IEC khz to 80 MHz d = 1,2 P 80 to 800 MHz d = 2,3 P 800MHz to 2,5 GHz where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufactuer and d is the recommended separation distance in meters (m). Radiated RF 3V/m 3V/m Field strength from fixed RF transmitters, IEC MHz to 2.5 GHz as determined by an electomagnetic site survey, a should be less than the compliance level in each frenquency range. b Interference may occur in the vicinity of equipment marked with the following symbol: NOTE 1: At 80 Mhz and 800 MHz, the separation distance for the higher frequency range applies. NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To access the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the FAST Sphyg is used exceeds the applicable RF compliance level above, the FAST Sphyg should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the FAST Sphyg. b Over the frequency range 150 khz to 80 MHz, field strengths should be less than 3 V/m 10

13 Guidance and Manufacturer s Declarations (cont.) Recommended Separation Distances The FAST Sphyg is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the FAST Sphyg can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the FAST Sphyg as recommended below, according to the maximum output power of the communications equipment. Rated maximum Separation distance according to frequency of transmitter (m) output power of transmitter (W) 150 khz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 Ghz d = 1,2 P d = 1,2 P d = 2,3 P For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (m) can be estimated using the equation 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 manufacturer. NOTE 1: At 80 MHz and 800 MHz, separation distance for the higher frequency range applies. NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. 11

14 Koven Technology, Inc. 477 N. Lindbergh Blvd., Suite 220 St. Louis, MO US Tel: Fax: GLN: Atlantico Systems 34 Oldfield Kingston, Galway, Ireland T: OM-1554 r08 8/4/16 FAST Sphyg Operation Manual Copyright Koven Technology, Inc.