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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