baxter EASYSPRAY User manual

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INSTRUCTIONS FOR USE
EASYSPRAY
PRESSURE REGULATOR
G4505_EasySpray_IFU_US_3OK 24.05.2005 15:06 Uhr Seite 1
IMPRIMATUR QO: C. Alam, 25 05 05

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EASYSPRAY
PRESSURE REGULATOR
Pressure gauge
sensing line
connector
pressure line
connector
Sterile filter luer-lock connectors
IV-pole clamp
Gas supply line
connector with filter
On/Off switch battery compartment
Pressure
control knob
Low-battery
indicator
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TABLE OF CONTENTS
1. Description 4
2. Warnings and Precautions 5
3. Storage 5
4. Operation 5
5. Cleaning / Maintenance 7
6. Terms of Guarantee 8
7. Return of Devices 9
8. Waste Disposal of Product 9
9. Technical Data 9
10. Manufacturer and Distributor 9
11. Electromagnetic Compatibility Information 10
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INSTRUCTIONS FOR USE
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1. DESCRIPTION
The EASYSPRAY Pressure Regulator controls and releases pressurized gas provided by a
propellant gas source. The EASYSPRAY device is to be used only with spray sets specified
for use with this pressure regulator.
Only qualified operating room personnel should operate the device, having first read this
manual carefully.
1.1 CONTENTS OF CARTON
1 EASYSPRAY Pressure Regulator
1 Instruction manual
1.2 ACCESSORIES
In addition to the EASYSPRAY device, a spray set device is required for the spray
application of surgical sealants. Only spray sets designated for use with the
EASYSPRAY device should be used. The spray sets consist of a sterile spray tip attached
to dual-lumen tubing for gas delivery and activation of the pressure-sensitive
on/off mechanism.
Contact your Baxter representative to obtain suitable spray sets.
1.3 SYMBOLS
4
Symbol Explanation
Classification of Device: Equipment provides a degree of
protection against electrical shock
Attention, See Instructions Manual
‘On’ position
‘Off’ position
Low Battery Indicator
DO NOT connect to an oxygen source
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2. WARNINGS AND PRECAUTIONS
• CAUTION: Pressurized gas supply must be between 3.5 and 7 bar.
• CAUTION: DO NOT connect to an oxygen source. Failure to follow these instructions
can lead to explosion, which could result in serious injury or death.
• Prior to operation make sure that the pressure range of the device is adjusted to the
range specified in the appropriate spray set instructions for use (See 4.1 FIRST-TIME
USE).
• CAUTION: Any application of pressurized gas may be associated with a potential risk
of air embolism, tissue rupture or gas entrapment with compression, which may be
life threatening. Be sure to take appropriate measures to address these risks by
observing the recommended minimum spraying distance and maximum pressure provided
in the appropriate spray set instructions for use.
• CAUTION: Spraying into enclosed body cavities requires appropriate safety measures
to make sure that the above mentioned risks will be avoided.
ATTENTION:
• DO NOT throw or drop the device!
• Do not use the device in the case of visible damage caused by improper handling. Return
damaged devices to Baxter for repair.
3. STORAGE
• Storage and Transport Conditions: Temperature -10º to 45ºC, 60% relative air
humidity.
• Protect from heat, dust, humidity, frost and direct sunlight.
If the device is not used on a regular basis, observe the following:
• Prior to each re-use, perform a functional test (See 4.1 FIRST-TIME USE).
• Connect the device to the pressurized gas supply and vent at the maximum pressure
by repeatedly closing the sensing line luer connector.
4. OPERATION
4.1 FIRST-TIME USE
After removing the device from the package, it is recommended to keep the carton for
potential maintenance or repair. Check the device visually for any mechanical damage
that could impair operation.
Open the battery compartment with the aid of a coin or screwdriver and insert a
standard 9 Volt battery. NOTE: Do not use rechargeable batteries.
Since operating rooms are equipped with various types of fittings for pressurized gas,
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the connection tube of the EASYSPRAY device is supplied without fittings. The
appropriate fitting must be mounted to the end of the supply line by technical service
personnel.
Prior to first time use, the protective caps have to be removed from the gas connections.
The recommended pressurized gas source is compressed air or nitrogen.
CAUTION: Pressurized gas supply must be between 3.5 and 7 bar.
4.2 PREPARING FOR OPERATION
The device should be visually inspected for any mechanical damage that could impair
the function at regular intervals.
If the low-battery indicator light is illuminated, change battery immediately.
If the device is no longer safe in function and/or operation, discontinue use and return
it to Baxter in accordance with Section 7 (RETURN OF DEVICES).
4.3 OPERATION
• The clamp on the back side of the EASYSPRAY device allows the device to be
mounted onto an IV-pole or a bed-rail. Firmly set screws to assure stable connection
to either the IV-pole or bed-rail.
• Connect the supply line to pressurized gas outlet in the OR (compressed air or
nitrogen).
CAUTION: Pressurized gas supply must be between 3.5 and 7 bar.
NOTE: Follow instructions for use for surgical sealant and spray device preparation.
• Connect the clear sterile filter of the spray set pressure line to the male luer connector
on the EASYSPRAY device. Connect the blue filter of the spray set sensing line to
the blue marked female luer connector on the EASYSPRAY device.
• Turn the switch on the front side of the EASYSPRAY device to the ON-position (I).
• Adjust the pressure on the EASYSPRAY device according to the specifications in the
spray set instructions for use by turning the regulator knob in the appropriate
direction.
• To activate the flow of gas, cover the sensing line outlet (the hole on the spray set clip)
as described in the spray set instructions for use.
• The quantity of product applied is controlled by the product application system but
not by the gas released.
• When spraying of sealant has been completed or the EASYSPRAY device is no
longer in use, turn the switch on the front side to the OFF-position (O).
CAUTION: For the recommended spraying distance, gas pressure and application
details read the spray set instructions for use carefully.
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5. CLEANING / MAINTENANCE
5.1 CLEANING
The EASYSPRAY housing can be cleaned with standard operating room disinfectants.
In order for the device to operate safely and in accordance with the intended use, the
device must be cleaned following use and maintained free of dirt and other debris.
5.2 PERIODIC TECHNICAL-SAFETY INSPECTIONS (OUTLINE)
The following technical safety inspection has to be performed periodically (at least once
a year) by the hospital technical service:
Pressurized Gas Supply Line:
1. Disconnect the device from the gas supply line connector.
2. Inspect the supply line for damage (breaks, leaks and wear)
3. Check the gas connector
Particle Filter:
1. Disconnect the device from the gas supply.
2. Dismount the filter housing (use wrench size SW 32mm if necessary).
3. Replace the filter element, inspect sealing rings for damage and replace if necessary.
(Filter and sealing ring set can be obtained from your Baxter representative.)
4. Mount the filter housing.
Labels:
Inspect all labels and stickers for legibility and completeness.
Mechanical Condition:
The external mechanical condition must allow safe operation and function of the
appliance. Carefully check for any damage to the Luer-Lock connections and ensure they
are tightly fastened.
Pressure Gauge:
Inspection of the pressure gauge:
1. Connect the EASYSPRAY device to the propellant gas supply.
2. Attach a calibration manometer (calibrator) with measuring range of at least
4 bar to the pressure line connector.
3. Switch the On/Off switch into the On position (I).
4. Close the sensing line connector.
5. Turn the pressure control knob to set a pressure of 1 bar on the calibrator.
6. The pressure displayed on the pressure gauge must be between 0.9 and 1.1 bar
7. Turn the pressure control knob to set a pressure of 2 bar on the calibrator.
8. The pressure displayed on the pressure gauge must be between 1.9 and 2.1 bar.
9. Turn the pressure control knob to set a pressure of 3 bar on the calibrator.
10.The pressure displayed on the pressure gauge must be between 2.9 and 3.1 bar.
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Overpressure Shut-Down:
Inspection of the overpressure shut-down mechanism:
1. Connect the EASYSPRAY device to the pressurized gas supply.
2. Switch the On/Off switch into the On position (I).
3. Use the pressure control knob to set a pressure of approx. 2.8 bar.
4. Attach a calibration manometer (calibrator) with measuring range of at least 4 bar
to the pressure line connector.
5. Dismount the pressure regulator knob with the aid of an Allen wrench (2.5 mm).
6. Remove the retaining washer.
7. Mount the pressure control knob.
8. Close/Cover the sensing line connector to start gas flow through the EASYSPRAY device
and set the output pressure to 2.8 bar.
9. Check the function of the EASYSPRAY device by starting it repeatedly, i.e., covering
and uncovering the sensing line connector.
10.Using the pressure regulator increase the output pressure by 0.1 bar.
11.Repeat points 9 and 10 until gas flow through the device is interrupted (shut-down
pressure has been reached).
12.The shut-down pressure must be between 3.1 bar and 3.7 bar (3.4 +/- 0.3 bar).
13. Switch the On/Off switch to Off (O).
14. Dismount the pressure control knob.
15. Reinstall the retaining washer.
16. Mount the pressure control knob.
Battery Inspection:
1. Open the battery compartment with the aid of a coin or screwdriver and remove the
battery from drawer.
2. Check the battery compartment and the drawer for contaminants.
3. Check the contact springs for corrosion.
4. Test the battery voltage (using a battery tester if necessary) or dispose of the battery
in accordance with the local regulations.
5. Re-insert the tested or new battery into the drawer and test the device for function.
6. TERMS OF GUARANTEE
The manufacturer guarantees that all defects in material and fabrication occurring
within 2 years after the date of sale are repaired free of charge.
This guarantee can only be claimed under the following conditions:
• Inform Baxter immediately of malfunction. Please provide the serial number of the device
when reporting.
• Observe all instructions regarding storage or return of the device.
• Present a legible copy of the invoice for the device in question, which clearly shows
the date of sale.
• Describe as exactly as possible the suspected defects or malfunctions by the user.
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ATTENTION: The guarantee will not be applicable, if directions for maintenance,
cleaning, and inspection in accordance with the instruction manual have not been followed.
The manufacturer and the supplier of the device deny liability, if:
• The device is not used in accordance with the instruction manual.
• The defect was not caused by the manufacturer or persons and service companies authorized
by the same.
7. RETURN OF DEVICES
Reasons for return:
1. Results of the first-time use tests are unsatisfactory/unsafe
2. Defective device
Please contact Baxter customer service to obtain a RETURN AUTHORIZATION (RA)
NUMBER prior to returning. Product returns will not be accepted without a Return Authorization
number.
When returning a device, clean it carefully and pack it in the original package. If the original
package is no longer available, the device has to be packaged in a manner corresponding
to the original package, i.e. individually and shockproof.
8. WASTE DISPOSAL OF PRODUCT
• Do not dispose product (device) as unsorted municipal waste.
• Collect product (device) separately.
• Use collection and return systems available to you.
9. TECHNICAL DATA
• Outer dimensions L 155 mm x W 240 mm x H 160 mm
• Gas supply line L 5 m x 6 mm
• Weight 1.8 kg
• Pressurized gas supply 3.5 – 7 bar
• Maximum pressure 3.0 +/- 0.2 bar
• Admissible pressurized gases Compressed air or nitrogen
• Operating conditions Temperature: 10º-40ºC, 30-75% relative
air humidity, avoid shocks and vibrations.
10. MANUFACTURER AND DISTRIBUTOR
Distributed in the USA by:
Baxter Healthcare Corporation
Westlake Village, CA 91362
1-800-423-2090
US: Rx Only
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11. ELECTROMAGNETIC COMPATIBILITY INFORMATION
according to IEC 60601-1-2:2001:
The EasySpray Pressure Regulator, as well as all medical electrical equipment, needs special precautions
regarding EMC (electromagnetic compatibility) and needs to be installed and put into service according
to the following information.
• Because the intensity of electromagnetic energy is greatest near the source of a transmitting
antenna, portable and mobile RF communications equipment can affect medical electrical equipment.
The EasySpray Pressure Regulator has been designed to withstand the effects of EMI (electromagnetic
interference) and meets the most current EMC standards that apply to the instrument. However, extremely
high levels of electromagnetic energy (above the levels of IEC 60601-1-2) may still produce interference.
To reduce the risk of EMI, follow these recommendations:
• Do not turn on or use hand-held personal communications devices, such as mobile two-way
radios or cellular phones, near the instrument. If these devices need to be used, follow the
“recommended separation distance” as shown in the following tables.
• In the case of unexplained EMI, consider the locations of nearby transmitters, such as radio or TV
stations. You may have to move the instrument or place shield material between the transmitter and
the instrument.
• Be aware that modifying the instrument or adding accessories or components, not specifically authorized
by Baxter, may make the instrument more susceptible to interference from radio waves.
WARNING: When servicing the instrument, use only replacement components, cables and accessories
authorized by Baxter and be sure to replace all shields, covers, screws, and gaskets in their exact locations
as described in the service manual. Failure to do so may result in increased emissions or decreased immunity
of the instrument.
WARNING: The EasySpray Pressure Regulator should not be used adjacent to, or stacked with, other
medical electrical equipment. However, if it is necessary to use the instrument close to other equipment,
the instrument should be observed to verify normal operation in the configuration in which it is intended
to be used.
Table 201 - Guidance and Manufacturer’s Declaration - Electromagnetic Emissions
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The EasySpray Pressure Regulator is intended for use in the electromagnetic environment
specified below. The user of the EasySpray Pressure Regulator should assure that it is used in such
an environment.
Emissions Test Compliance Electromagnetic Environment - Guidance
RF emissions The EasySpray Pressure Regulator uses RF
CISPR 11 Group 1 energy only for its internal function. Therefore,
its RF emissions are very low and are not likely
to cause any interference in nearby electronic
equipment.
RF emissions The EasySpray Pressure Regulator is suitable for
CISPR 11 Class B use in all establishments, including domestic
establishments and those directly connected to
the public low-voltage power supply network
that supplies buildings used for domestic
purposes.
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Table 202 - Guidance and Manufacturer’s Declaration - Electromagnetic Immunity
Table 204 - Guidance and Manufacturer’s Declaration - Electromagnetic Immunity
– For Equipment and Systems that are Not Life-Supporting
BAXTER and EASYSPRAY are trademarks of Baxter International Inc., its subsidiaries or
affiliates.
The EasySpray Pressure Regulator is intended for use in the electromagnetic environment
specified below. The user of the EasySpray Pressure Regulator should assure that it is used in such
an environment.
Immunity Test IEC 60601 Compliance Electromagnetic Environment
Test Level Level - Guidance
Electrostatic ±6 kV contact ±6 kV contact Floors should be wood, concrete or ceramic
Discharge (ESD) tile. If floors are covered with synthetic
material, the relative humidity should
IEC 61000-4-2 ±8 kV air ±8 kV air be at least 30%.
Power frequency Power frequency magnetic fields should
(50/60 Hz) 3 A/m 3A/m be at levels characteristic of a typical
magnetic field location in a typical commercial or hospital
IEC 61000-4-8 environment.
The EasySpray Pressure Regulator is intended for use in the electromagnetic environment
specified below. The user of the EasySpray Pressure Regulator should assure that it is used in such
an environment.
Immunity Test IEC 60601 Compliance Electromagnetic Environment
Test Level Level - Guidance
Field strengths from fixed RF transmitters,
as determined by an electromagnetic site
Radiated RF 3V/m 80 MHz 3V/m surveyashould be less than the compliance
IEC 61000-4-3 to 2.5 GHz level in each frequency range.
Interference may occur in the vicinity of
equipment marked with the following
symbol:
NOTE 1 At 80 MHz and 800 MHz, the higher frequency 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 assess 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 EasySpray Pressure
Regulator is used exceeds the applicable RF compliance level above, the EasySpray Pressure Regulator should
be observed to verify normal operation. If abnormal performance is observed, additional measures may be
necessary, such as re-orienting or relocating the EasySpray Pressure Regulator.
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Baxter Healthcare Corporation
Westlake Village, CA 91362
1-800-423-2090
US: Rx Only
6299610EH04
b
EASYSPRAY
PRESSURE REGULATOR
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