Koven FASTSphyg User manual

GTIN: 00894912002920

FASTSphyg by Koven
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
Specications ...................................................................................................................6
Cleaning & Maintenance ..................................................................................................7
Warranty ...........................................................................................................................7
Safety Standards.........................................................................................................8-11

FASTSphyg by Koven
Thank you for purchasing the FAST Sphyg
by Koven
This operation manual is intended to assist you to safely and efciently
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 ination
User controlled deation
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.
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FASTSphyg by Koven
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 inated
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 uid 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 ination beyond 270 mmHg is possible when using small cuffs.
WARNING: If modications 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 specied 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.
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FASTSphyg by Koven
CONTROLS
Gauge Face Displays the pressure reading in mmHg
Trigger Valve To deate the cuff
Actuator Button To inate the cuff
Tubing Connector Port To connect extender tubing
Battery Status Indicator 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)
DC Jack To plug in the AC charger
AC Charger To recharge the battery
Strap Connector To connect the wrist strap
1
2
3
4
5
6
1
2
3
6
5
8
8
8
4
7
7
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FASTSphyg by Koven
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 ve (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.
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.
5. Press the actuator button to begin cuff ination. There will be a slight delay before
ination 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 inated approximately 20 mmHg past the point where waveform motion
and/or sound ceases (K5). Release the button to stop cuff ination. Press the
actuator button again to continue ination.
6. Gradually deate the cuff at a rate of 2-3 mmHg per second by pressing down on the
trigger until sound and/or waveform motion returns.
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 counter-
clockwise.
NOTE: For correct cuff sizing, refer to your cuff manufacturer’s guidelines.
NOTE: Before inating the cuff, be sure the trigger valve lock mechanism is
released.
NOTE: In children ages 3 - 12, inate the cuff until sound is mufed (K4). K5
should be used for pregnant female patients, unless sounds are audible when
the cuff is deated, in which case K4 should be used.
NOTE: Altering the pressure applied to the trigger valve during deation affects
the deation rate.
NOTE: For rapid deation, squeeze the trigger valve until it clicks and locks
into place.
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FASTSphyg by Koven
RECHARGING THE BATTERY
This device uses a rechargeable Lithium-Ion battery.
When the battery is low, the battery status indicator light will start to ash 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.
Type B Applied Symbol for the marking
Part of electrical and electronics
devices according to
AC Charger Directive 2002/96/EC.
Connector The device, accessories &
packaging must to be disposed of
ON/OFF correctly at the end of the usage.
Push Button Please follow local ordinances or
regulations for disposal.
Follow Operating Class II Device
Instructions
Caution Latex Free
Manufacturer Temperature Limit
Date of Manufacture Humidity Limit
Authorized European Lot Number
Representative
SYMBOLS
Symbol Description Symbol Description
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 314-542-2101 or [email protected].
5
NOTE: It takes approximately 1 hour to fully recharge the battery.
NOTE: The device will not operate while plugged in.

FASTSphyg by Koven
SPECIFICATIONS
Nominal Pressure Range: 0 - 300 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
Ination 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 IEC60601-1
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
* Specications are subject to change
INCLUDES:
FAST Aneroid Sphygmomanometer
AC Charger (1), Wrist Strap (1), Male Luer Connector (1)
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FASTSphyg by Koven
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.
DO NOT DISMANTLE. Gauge accuracy can be checked
visually by verifying that the needle rests within the
printed oval (gure 1) when the unit is fully deated. 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 certied to national
or international measurement standards. Call Koven
Technology service if you have a sphyg in need or
calibration or for any calibration questions.
No sphygmomanometer that has the indicator needle
resting outside of this mark is acceptable for use.
WARRANTY
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 314-542-2101 or [email protected]. The warranty does not cover defects resulting
from accidents or misuse and is void if modications of parts are attempted without
permission.
If the warranty period has expired, please contact Koven Technology, Inc. for a charged
repair service.
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 gure
2). The Lot number is located on the outside package label
and is designated with the symbol.
CAUTION: Do not submerge the FAST Sphyg in any liquid.
gure 1
gure 2
Serial
Number
7
14000001

FASTSphyg by Koven
8
SAFETY STANDARDS
The FAST conforms to the following standards:
Manufacturing standard: IEC60601-1
1. 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 81060-1 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 specied 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 61000-3-3