Precision Trading Respiratory Product PM5200 User Manual

USER MANUAL  
AiR-OxygEN BLENdER  
(diSS and NiST Connections)  
Model No. PM5200 Series  
PM5300 Series  
(shown)  
SAVE THESE iNSTRUCTiONS  
Federal (USA) law restricts this device to sale  
by or on the order of a physician.  
CAUTiON  
300 Held Drive  
Northampton, PA 18067 USA  
Tel: (+001) 610-262-6090  
Fax: (+001) 610-262-6080  
Download from Www.Somanuals.com. All Manuals Search And Download.  
RECEiViNg / iNSPECTiON  
Remove the Precision medical, Inc. Air-Oxygen Blender from  
the packaging and inspect for damage. If there is any damage,  
DO NOT USE and contact your Provider.  
iNTENdEd USE  
Precision medical, Inc. Air-Oxygen Blender dispenses a  
continuous and precise blend of medical air and USP oxygen  
via outlet ports to infant, pediatric and adult patients. The exact  
FractionalConcentrationofInspiredOxygen(FiO2)blendofgases  
corresponds to the dialed in FiO2 setting indicated by the control  
knob (dial).  
REAd ALL iNSTRUCTiONS BEFORE USiNg  
This manual instructs a Professional to install and operate the  
Air-Oxygen Blender. This is provided for your safety and to prevent  
damage to the Air-Oxygen Blender. If you do not understand this  
manual, DO NOT USE the Air-Oxygen Blender and contact your  
Provider.  
dANgER  
This product is not intended as a life-sustaining or life-  
supporting device.  
ExPLANATiON OF ABBREViATiONS  
FiO2  
DISS  
NIST  
psi  
Fractional Concentration of Inspired Oxygen  
Diameter Indexed Safety System  
Non-Interchangeable Screw Thread  
Pounds Per Square Inch  
lpm  
Liters Per minute  
Blender  
Air-Oxygen  
2
Download from Www.Somanuals.com. All Manuals Search And Download.  
SAFETy iNFORMATiON - WARNiNgS ANd CAUTiONS  
Indicates an imminently hazardous situation  
which, if not avoided, will result in death or  
serious injury.  
dANgER  
Indicates a potentially hazardous situation  
which, if not avoided, could result in death or  
serious injury.  
WARNiNg  
Indicates a potentially hazardous situation  
which, if not avoided, may result in minor or  
moderate injury.  
CAUTiON  
Used without the safety alert symbol indicates  
a potentially hazardous situation which, if not  
avoided, may result in property damage.  
CAUTiON  
CONSULT ACCOmPANYING DOCUmENTS  
Symbol for “USE NO OIL”  
Symbol indicates the device complies with the  
requirements of Directive 93/42/EEC concerning  
medical devices and all applicable International  
Standards. (On CE marked devices ONLy)  
WARNiNg  
• Only trained, qualified medical personnel under the  
direct supervision of a licensed physician should operate  
the Air-Oxygen Blender .  
• Use this Air-Oxygen Blender only for its Intended Use as  
described in this manual.  
• Confirm prescribed dose before administering to patient.  
monitor on a frequent basis.  
• The Air-Oxygen Blender shall be serviced by a qualified  
service technician.  
• Always follow ANSI and CGA standards for medical Gas  
Products, Flowmeters and Oxygen Handling.  
Blender  
Air-Oxygen  
3
Download from Www.Somanuals.com. All Manuals Search And Download.  
WARNiNg  
• An Oxygen Analyzer/monitor must be used to verify  
oxygen concentration.  
• Accuracy of oxygen concentration will be affected if bleed  
is not activated at flow settings below 15 lpm for the High  
Flow Blender, and 3 lpm for the Low Flow Blender.  
• dO NOT obstruct the alarm.  
• dO NOT use Blender when alarm is sounding.  
• dO NOT use oil in or around the Blender.  
• dO NOT occlude or obstruct the bleed port on the  
auxiliary outlet of the Blender.  
• dO NOT use near any type of flame or flammable/  
explosive substances, vapors or atmosphere.  
Oxygen Concentration dial does not rotate 360 degrees.  
Rotating the dial less than 21% or over 100% oxygen will  
damage the Blender.  
CAUTiON  
Turn off gas supplies when Air-Oxygen Blender is not in use.  
• Store the Air-Oxygen Blender in a clean, dry area when  
not in use.  
• The Air-Oxygen Blender contains magnetic, ferrous  
material that may affect the results of an mRI.  
• Ensure all connections are tight and leak free.  
• Avoid excessive pressure surges greater than 100 psi  
(6.9 bar) when pressuring the Blender inlets.  
• dO NOT steam autoclave.  
• dO NOT immerse Air-Oxygen Blender into any liquid.  
• dO NOT gas sterilize with (ETO) Ethylene Trioxide.  
• dO NOT use if dirt or contaminants are present on or  
around the Blender or connecting devices.  
• dO NOT smoke in an area where oxygen is being  
administered.  
• dO NOT clean with aromatic hydrocarbons.  
Blender  
Air-Oxygen  
4
Download from Www.Somanuals.com. All Manuals Search And Download.  
SPECiFiCATiONS  
Model  
PM5200 High Flow PM5300 Low Flow  
15 - 120 lpm 3 - 30 lpm  
Primary Outlet  
Flow Range  
With both supply pressures at 50 psi (3.4 bar)  
with NO BLEED  
2 - 100 lpm  
0 - 30 lpm  
Auxiliary Outlet  
Flow Range  
With both supply pressures at 50 psi (3.4 bar)  
with BLEED  
13 lpm or less  
3 lpm or less  
Bleed Flow  
at 50 psi (3.4 bar)  
at 50 psi (3.4 bar)  
Maximum  
Combined  
Flow (All Outlets)  
120 lpm  
30 lpm  
Bypass Flow  
(Loss of Air or  
Oxygen supply)  
> 85 lpm  
> 45 lpm  
Bypass Alarm  
Activation  
50 psi  
60 psi  
50 psi  
60 psi  
(3.45 bar) (4.14 bar) (3.45 bar) (4.14 bar)  
13-25 psi 16-24 psi 18-22 psi 16-24 psi  
0.9-1.7 bar 1.1-1.65 bar 1.2-1.5 bar 1.1-1.65 bar  
When pressure differential is  
6 psi (0.4 bar) or less.  
Alarm Reset:  
to 80 db at 1 ft (0.3 m)  
Alarm Sound Level:  
Oxygen Concentration  
Adjustment Range:  
21 - 100%  
30 - 75 psi (2.1 - 5.2 bar)  
Air and Oxygen within 10 psi (0.67 bar)  
of each other  
gas Supply Pressure:  
1% Oxygen  
Mixed gas Stability:  
DISS Type - Air & Oxygen Inlets & Outlets  
and / or  
Connection Types:  
NIST Type - Air & Oxygen Inlets  
Blender  
Air-Oxygen  
5
Download from Www.Somanuals.com. All Manuals Search And Download.  
SPECiFiCATiONS continued  
dimensions: (without fittings)  
(12.5 cm)  
(5.7 cm)  
(10.4 cm)  
(1.3 kg)  
Depth:  
Width:  
Height:  
4.9 in  
2.3 in  
4.1 in  
2.9 lbs  
3.5 lbs  
Weight:  
(1.6 kg)  
Shipping Weight:  
Operating Temperature Range:  
59°F to 104°F (15°C to 40°C)  
Transport / Storage Requirements  
-10°F to 140°F (-23°C to 60°C)  
Temperature Range:  
max 95% Noncondensing  
Humidity:  
3% of full scale @ 50 psi (3.4 bar)  
4% of full scale @ 60 psi (4.14 bar)  
FiO2 Accuracy:*  
Pressure drop:  
Low Flow:  
2 psi (0.14 bar) at inlet pressures from 30-90 psi  
(2.1- 6.2 bar) and at 10 lpm flow rate at 60% FiO2  
3 psi (0.21 bar) at inlet pressures from 30-90 psi  
(2.1- 6.2 bar) and at 30 lpm flow rate at 60% FiO2  
.
High Flow:  
.
The Air-Oxygen Blender has been degreased for Oxygen Service prior to delivery.  
The Air-Oxygen Blender reverse gas flow complies with clause 6 of ISO 11195.  
The Oxygen Analyzer should comply with ISO 7767 to meet CE requirement.  
dryness and Composition for inlet gases:  
medical Air supply should meet the requirements of  
ANSI Z86.1 - 1973 commodity specification for Air, type  
1 grade D or better.  
Air:  
Oxygen supply must meet all requirements of USP  
medical Oxygen Grade N.  
Oxygen:  
Both inlets should remain 10°F (5.5°C) or more  
below the lowest temperature to which the air  
distribution system equipment is exposed. At a  
temperature of 25°F (-3.9°C) and a pressure of  
90 psi (6.33 kg/cm2) this equates to 2000 mg/m3.  
dew Point:  
(ONLY for CE  
requirements)  
* Accuracy of oxygen concentration will be affected if bleed is not activated at flow settings below 15 lpm for the high flow  
Blender, and 3 lpm for the low flow Blender.  
Specifications are subject to change without prior notice.  
Blender  
Air-Oxygen  
6
Download from Www.Somanuals.com. All Manuals Search And Download.  
diAgRAMS  
CAUTiON  
missing or illegible labels must be replaced, contact  
Precision medical, Inc.  
depending on model, your fittings may differ from these diagrams.  
Pm5200 model  
Pm5300 model  
B
E
A
F
B
G
I
D
C
H
Blender  
Air-Oxygen  
7
Download from Www.Somanuals.com. All Manuals Search And Download.  
COMPONENT dESCRiPTiON  
ITEM  
DESCRIPTION  
A
Oxygen Concentration dial  
A dial used for selecting oxygen concentrations between  
21%-100%. The FiO2 scale is used for reference only.  
This dial does not rotate 360°. The dial starts at 21%  
and ends at 100%.  
B
C
Primary Outlet Port  
A male DISS oxygen fitting with check valve that delivers  
flow when engaged to any controlling device, such as  
a flowmeter.  
Auxiliary Outlet Port  
A male DISS oxygen fitting with check valve that delivers  
flow when engaged to any controlling device, such as a  
flowmeter. This outlet is equipped with a bleed valve that  
allows the user to control if the bleed is ON or OFF. With  
the bleed in the ON position, this outlet delivers accurate  
oxygen concentrations in the following flows:  
Model  
High Flow  
Low Flow  
Flow Range  
2 – 100 lpm  
0 – 30 lpm  
d
Auxiliary Bleed Collar  
The collar is used to engage and disengage the bleed.  
The bleed is necessary to maintain accurate FiO2  
Concentration below 15 lpm for the High Flow and 3  
lpm for the Low Flow. This collar is designed to prevent  
accidental disengagement of the bleed. To activate  
the bleed, turn the knurled collar until the bleed pin is  
engaged. Slide collar back until it contacts the cover.  
To deactivate the bleed, pull collar away from cover  
while rotating until the collar slot engages the pin, turn  
additional 1/4 turn to lock in place.  
E
Oxygen inlet Fitting  
A female DISS or NIST oxygen fitting with one way valve  
that is used to connect an oxygen supply hose.  
Blender  
Air-Oxygen  
8
Download from Www.Somanuals.com. All Manuals Search And Download.  
COMPONENT dESCRiPTiON  
ITEM  
DESCRIPTION  
F
Air inlet Fitting  
A male DISS or NIST air fitting with one way valve  
that is used to connect an air supply hose.  
g
Alarm  
An audible alarm that sounds due to an excessive  
pressure drop or deletion of either gas supply.  
H
i
Manifold Outlet (Optional)  
manifold with 3 primary outlets.  
Rear Slide Mount with dove tail.  
iNSTALLATiON  
WARNiNg  
• Read this User manual before installing or operating the  
Air-Oxygen Blender.  
• Confirm the concentration of air/oxygen with an Oxygen  
Analyzer/monitor.  
1. Secure the Air-Oxygen Blender to a wall or pole bracket in an  
upright position.  
2. It is recommended to install a condensation trap in the air  
supply line.  
3. Connect the air and oxygen supply lines to the appropriate  
inlet fittings on the bottom of the Blender.  
4. Attach a flowmeter, or other metering device to one of the  
outlet ports.  
Primary Outlets Flow capacity:  
• High Flow Blender (Pm 5200 model) 15 lpm to 120 lpm  
• Low Flow Blender (Pm 5300 model) 3 lpm to 30 lpm  
Auxiliary Outlet:  
This will bleed off some of the air/oxygen mixture to  
maintain concentration accuracy at the Low Flow setting.  
High Flow Blender (Pm 5200 model) 15 lpm or less  
• Low Flow Blender (Pm 5300 model) 3 lpm or less  
5. Attach a supply line to the outlet port of the flowmeter.  
Blender  
Air-Oxygen  
9
Download from Www.Somanuals.com. All Manuals Search And Download.  
ALARM TEST  
1. The Air-Oxygen Blender is installed and the flowmeter is turned  
on. Disconnect or turn off the air supply line to the Air-Oxygen  
Blender.  
2. The Blender should alarm with a loud whistle noise. The whistle  
indicates the alarm is operating correctly.  
3. Reconnect and activate the air supply line to the Blender, the  
alarm should stop whistling.  
4. Disconnect or turn off the oxygen supply line to the Blender.  
5. The Blender should alarm with a loud whistle noise. The whistle  
indicates the alarm is operating correctly.  
6. Reconnect and activate the oxygen supply line to the  
Blender, the alarm should stop whistling.  
7. If alarm fails to function properly, DO NOT USE.  
REVERSE gAS FLOW PROCEdURE  
(CE Requirements ONLY)  
1. Disconnect the oxygen hose from the gas source. Remove all  
outlet connections from the Blender to ensure that there is no  
outlet flow.  
2. Place the free end of the oxygen supply hose under water. While  
gradually increasing the air supply pressure from 30-75 psi (2.07-  
5.17 bar) check for leakage past the oxygen inlet check valve.  
3. Replace the Duckbill Check Valve in the oxygen inlet if  
bubbles indicate leakage. Reference Air-Oxygen Blender  
Service manual (P/N 504827.)  
4. Repeat steps 1-3 to check for leakage past the air inlet check  
valve.  
OPERATiNg iNSTRUCTiONS  
CAUTiON  
Inspect the Air-Oxygen Blender for visual damage before  
use, DO NOT USE if damaged.  
1. Turn “ON” the Air and Oxygen supply.  
2. Adjust the Oxygen Concentration Dial to the prescribed  
concentration.  
NOTE: The Oxygen Concentration Dial does not rotate  
360°. dO NOT force dial less than 21% or over 100%  
oxygen, this will damage the Blender.  
Blender  
Air-Oxygen  
10  
Download from Www.Somanuals.com. All Manuals Search And Download.  
3. To activate the bleed, turn the knurled collar until the bleed  
pin is engaged. Then slide the collar back until it contacts the  
cover.  
4. Confirm the concentration of air/oxygen with an Oxygen  
Analyzer/monitor.  
5. Confirm the flow of air and/or oxygen mixture to the patient.  
6. Turn “OFF” the Air and Oxygen supply when deactivating the  
Auxiliary bleed, and no device is attached to the outlet port.  
7. To deactivate the bleed, pull the collar out away from the cover  
while rotating the collar until the slot engages the pin. Then  
1
slide the collar past the pin and turn an additional /4 turn to  
lock in place.  
NOTE: This Procedure is completed with ease when all gas  
supplies to the Blender are turned “OFF”.  
8. Turn “OFF” the Air and Oxygen supply or disconnect when  
the Blender is not in use.  
9. Operational Verification listed below should be done before  
the Blender is placed in service.  
Verification consists of:  
• Alarm Test  
Verify FiO2 Concentration witha Oxygen Analyzer/monitor  
• Reverse Gas Flow Procedure  
PERFORMANCE CHECk  
A detailed description of the tests listed below can be found in the  
Blender Service manual (P/N 504827), available on the Internet;  
• Reverse Gas Flow Procedure  
• Operational Verification Procedure (OVP)  
CLEANiNg  
CAUTiON  
• dO NOT steam autoclave.  
• dO NOT immerse the Air-Oxygen Blender into any liquid.  
• dO NOT use any strong solvent or abrasive cleaners.  
• dO NOT gas sterilize with (ETO) Ethylene Trioxide.  
• dO NOT clean with aromatic hydrocarbons.  
Blender  
Air-Oxygen  
11  
Download from Www.Somanuals.com. All Manuals Search And Download.  
1. Disconnect all gas connections and equipment before  
cleaning.  
2. Clean exterior surfaces with a cloth dampened with mild  
detergent and water.  
3. Wipe dry with a clean cloth.  
MAiNTENANCE  
The following maintenance on the Air-Oxygen Blender must be  
performed by a trained service technician:  
• Every month verify proper functioning of alarm.  
Every year conduct the Operational Verification Procedure (OVP).  
• Every 2 years the Air-Oxygen Blender should be serviced.  
PM5200 (P/N 505407) PM5300 (P/N 504932)  
• RefertotheAir-OxygenBlenderServicemanual(P/N504827)  
for complete details regarding further maintenance and  
testing.  
TECHNiCAL dESCRiPTiON  
For a complete Technical Description of the Air-Oxygen Blender  
and list of Replacement Parts, reference the Air-Oxygen Blender  
Service manual (P/N 504827) available on the Internet;  
RETURNS  
Returned products require a Returned Goods Authorization  
(RGA) number, contact Precision medical, Inc. All returns must  
be packaged in sealed containers to prevent damage. Precision  
medical, Inc. will not be responsible for goods damaged in transit.  
Refer to Precision medical, Inc. Return Policy available on the  
diSPOSAL iNSTRUCTiONS  
This device and its packaging contain no hazardous materials.  
No special precautions need to be taken when disposing the  
device and/or its packaging.  
Please Recycle  
Blender  
Air-Oxygen  
12  
Download from Www.Somanuals.com. All Manuals Search And Download.  
TROUBLESHOOTiNg  
If the Air-Oxygen Blender fails to function, consult the  
Troubleshooting Guide below.  
If problem cannot be solved by using Troubleshooting Guide  
refer to the Air-Oxygen Blender Service manual (P/N 504827)  
your Provider.  
Problem  
Probable Cause  
Remedy  
Oxygen  
concentration  
discrepancy  
1. High Flow model,  
flow requirement  
below 15 lpm.  
1. Use auxiliary outlet  
& engage bleed  
between Blender Low Flow model,  
setting and  
Analyzer/monitor  
flow requirement  
below 3 lpm.  
(greater than 3%) 2. Analyzer/monitor  
2. Recalibrate  
inaccurate  
Analyzer/monitor or  
Verify with second  
Analyzer/monitor  
3. Remove obstruction  
3. Low flow bleed  
obstructed  
4. Gas supply  
contaminated  
4. Check gas sources  
with calibrated  
Oxygen Analyzer/  
monitor to confirm  
Oxygen is 100% and  
Air is 21%  
5. Downstream device  
causing back flow  
or restricted flow  
5. Isolate Blender.  
Check oxygen  
concentration at  
Blender Outlets  
No flow at  
Blender outlets  
1. Gas sources turned 1. Turn gas sources  
“OFF”  
“ON”  
2. Gas sources not  
connected  
2. Connect gas  
sources  
Alarm sounding  
1. Difference between 1. Correct pressure  
Oxygen and air inlet  
pressures greater  
than specified  
difference until  
Air and Oxygen  
pressures are within  
specification  
Blender  
Air-Oxygen  
13  
Download from Www.Somanuals.com. All Manuals Search And Download.  
LiMiTEd WARRANTy  
ANd  
LiMiTATiON OF LiABiLiTy  
Precision medical, Inc. warrants that the Blender, (the Product), will be  
free of defects in workmanship and/or material for the following period:  
Two (2) years from shipment  
Shouldanyfailuretoconformtothiswarrantyappearwithintheapplicable  
period, Precision medical, Inc. shall, upon written notification thereof and  
substantiationthatthegoodshavebeenstored,installed,maintainedand  
operated in accordance with Precision medical, Inc.’s instructions and  
standard industry practice, and that no modifications, substitutions, or  
alterations have been made to the goods, correct such defect by suitable  
repair or replacement at its own expense.  
ORAL STATEmENTS DO NOT CONSTITUTE WARRANTIES.  
The representatives of Precision medical, Inc. or any retailers are not  
authorized to make oral warranties about the merchandise described in  
this contract, and any such statements shall not be relied upon and are  
not part of the contract for sale. Thus, this writing is a final, complete and  
exclusive statement of the terms of that contract.  
THIS WARRANTY IS ExCLUSIVE AND IS IN LIEU OF ANY WARRANTY  
OF mERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE OR  
OTHER WARRANTY OF QUALITY, WHETHER ExPRESS OR ImPLIED.  
Precision medical, Inc. shall not under any circumstances be liable for  
special, incidental or consequential damages including but not limited to  
lost profits, lost sales, or injury to person or property. Correction of non-  
conformities as provided above shall constitute fulfillment of all liabilities  
of Precision medical, Inc. whether based on contract, negligence, strict  
tort or otherwise. Precision medical, Inc. reserves the right to discontinue  
manufacture of any product or change product materials, designs, or  
specifications without notice.  
Precision medical, Inc. reserves the right to correct clerical or  
typographical errors without penalty.  
Blender  
Air-Oxygen  
14  
Download from Www.Somanuals.com. All Manuals Search And Download.  
dECLARATiON OF CONFORMiTy  
manufacturer:  
Precision medical, Inc.  
300 Held Drive, Northampton, PA 18067, USA  
CONTACT: Quality manager  
Phone: 610-262-6090  
Authorized European Representative: Emergo Europe  
molenstraat 15  
2513 BH, The Hague  
The Netherlands  
Product:  
Gas mixers for medical Use  
Pm5200EN, Pm5200mEN, Pm5300EN, Pm5300mEN  
IIb  
model(s):  
mDD Class:  
Classification criteria:  
Clause 3.1 Rule 11 of Annex Ix of mDD  
As delivered, the object of the declaration described above is in conformity with the  
requirements of mDD 93/42/EEC Annex II.3 and the following documents:  
Document  
ISO 14971  
Title  
Edition  
medical Devices - Application of Risk management 2000+A1:2003  
to medical Devices  
EN 980  
Graphical Symbols for Use in the Labeling of medical  
Devices  
2003  
1998  
EN 1041  
Information supplied by the manufacturer with medical  
Devices  
ISO 11195  
ISO 15001  
Gas mixers for medical use - stand alone gas mixers  
1995  
2004  
Anesthetic and respiratory equipment -- Compatibility  
with oxygen  
Notified Body:  
TÜV Rheinland Products Safety GmbH  
EC Certificate No.: HD600119110 0001  
ISO 13485 Certified  
504745 Rev8 (E) 03/18/08 (?m) Printed in USA  
Download from Www.Somanuals.com. All Manuals Search And Download.  

Peavey Microphone ACM 2 User Manual
Peavey Stereo Amplifier WMA 150 User Manual
Pelco Security Camera C2469M A ML User Manual
Philips Handheld TV RD 0525C User Manual
Philips Work Light 281337 User Manual
Pioneer Car Stereo System DEH 23UB User Manual
Pioneer Flat Panel Television PDP 5000EX User Manual
Pioneer Marine Radio MVH P8200 User Manual
Planar Car Video System PL2410W User Manual
PYLE Audio Car Stereo System PIFMDK6 User Manual