Helio PM5500 User Manual

USER MANUAL  
HELIO2  
HELIUM-OxygEn BLEndEr  
(DISS and NIST Connections)  
Model No. PM5400 Series  
PM5500 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  
Tel: (+001) 610-262-6090  
Northampton, PA 18067 USA  
Fax: (+001) 610-262-6080  
REAd ALL INSTRUCTIONS BEFORE USING  
This manual instructs a Professional to install and operate the HELIO2 Blender.  
This is provided for your safety and to prevent damage to the HELIO2 Blender.  
If you do not understand this manual, DO NOT USE the HELIO2 Blender and  
contact your Provider.  
dANGER  
This product is not intended as a life-sustaining or life-supporting device.  
ExPLANATION OF ABBREVIATIONS  
FIHe-O2  
Fractional Concentration of Inspired Helium-Oxygen  
Fractional Concentration of Inspired Oxygen  
Helium-Oxygen  
FIO2  
Heliox  
DISS  
NIST  
psi  
Diameter Indexed Safety System  
Non-Interchangeable Screw Thread  
Pounds Per Square Inch  
lpm  
Liters Per Minute  
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)  
Prescription Required  
HELIO2  
BLENDEr  
HELIUM-OxygEn  
2
WARNING  
Only trained, qualified medical personnel under the direct supervision of a  
licensed physician should operate the HELIO2 Blender.  
Use this HELIO2 Blender only for its Intended Use as described in this  
manual.  
• Confirm prescribed dose before administering to patient. Monitor on a  
frequent basis. Continuous Monitoring with an alarmed Oxygen Monitor  
/ Analyzer is recommended.  
The HELIO2 Blender shall be serviced by a qualified service technician.  
Always follow ANSI and CGA standards for Medical Gas Products,  
Flowmeters and Oxygen Handling.  
The clinician must verify the Heliox tank concentration prior to utilizing  
the Blender.  
An alarmed Oxygen Monitor / Analyzer 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 beyond the endpoint settings will damage the Blender.  
CAUTION  
Turn off gas supplies when HELIO2 Blender is not in use.  
• Store the HELIO2 Blender in a clean, dry area when not in use.  
• The HELIO2 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 HELIO2 Blender into any liquid.  
• DO NOT gas sterilize with (EtO) Ethylene Oxide.  
• 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.  
• Inlet pressure of Device used in conjunction with the HELIO2 Blender must  
match inlet pressure of FIO2 Blender.  
HELIO2  
BLENDEr  
HELIUM-OxygEn  
3
SPECIFICATIONS  
High Flow  
Low Flow  
Model  
PM5580: 80/20 heliox PM5480: 80/20 heliox  
PM5570: 70/30 heliox PM5470: 70/30 heliox  
15 - 120 lpm  
3 - 30 lpm  
Primary Outlet  
Flow Range  
With both supply pressures at 50 psi (3.4 bar) with  
BLEED Closed  
2 - 100 lpm  
0 - 30 lpm  
Auxiliary Outlet  
Flow Range  
With both supply pressures at 50 psi (3.4 bar) with  
BLEED Open  
13 lpm or less  
3 lpm or less  
Bleed Flow @  
at 50 psi (3.4 bar)  
at 50 psi (3.4 bar)  
100% FIO2  
Maximum  
Combined  
120 lpm  
30 lpm  
Flow (All Outlets)  
Bypass Flow  
(Loss of Helium or  
Oxygen supply)  
> 85 lpm  
> 45 lpm  
Bypass Alarm  
Activation  
50 psi  
(3.45 bar)  
60 psi  
(4.14 bar) (3.45 bar)  
50 psi  
60 psi  
(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:  
Alarm Sound Level:  
to 80 db at 1 ft (0.3 m)  
Oxygen Concentration  
Adjustment Range:  
PM5480  
PM5580  
20 -  
100%  
PM5470  
PM5570  
30 - 100%  
30 - 75 psi (2.1 - 5.2 bar) Heliox & Oxygen  
within 10 psi (0.69 bar) of each other  
Gas Supply Pressure:  
Mixed Gas Stability:  
±1% Oxygen  
Connection Types:  
DISS Type - Heliox & Oxygen Inlets & Outlets  
and / or NIST Type - Heliox & Oxygen Inlets  
Note: All flow-rate values are as measured from an Oxygen flowmeter (uncorrected).  
HELIO2  
BLENDEr  
HELIUM-OxygEn  
4
SPECIFICATIONS continued  
dimensions: (without fittings)  
(12.5 cm)  
(5.7 cm)  
(10.4 cm)  
(1.3 kg)  
Depth:  
4.9 in  
2.3 in  
4.1 in  
2.9 lbs  
3.5 lbs  
Width:  
Height:  
Weight:  
(1.6 kg)  
Shipping Weight:  
59°F to 104°F (15°C to 40°C)  
Operating Temperature Range:  
Transport / Storage Requirements  
-10°F to 140°F (-23°C to 60°C)  
Temperature Range:  
Humidity:  
Max 95% Noncondensing  
± 3% of full scale @ 50 psi (3.4 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  
.
High Flow: 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  
.
The Helium-Oxygen Blender has been cleaned for Oxygen Service prior to delivery.  
The Helium-Oxygen Blender reverse gas flow complies with clause 6 of ISO 11195.  
The alarmed Oxygen Monitor / Analyzer should comply with ISO 7767 to  
meet CE requirement.  
dryness and Composition for inlet gases:  
Heliox:  
Medical grade 80/20 or 70/30 is required.  
Oxygen:  
Oxygen supply must meet all requirements of USP  
Medical Oxygen.  
dew Point: Both inlets should remain 10°F (-12.2°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.  
(ONLY for CE  
requirements)  
* Accuracy of FIO2 will be affected if bleed flow is not engaged at low flows. (At or below 3 lpm for Low Flow and 15 lpm for High Flow)  
.
* When Heliox tank pressure and oxygen outlet pressures are unbalanced, bleed may need to be engaged at a higher liter flow  
to maintain accuracy.  
Specifications are subject to change without prior notice.  
HELIO2  
BLENDEr  
HELIUM-OxygEn  
5
dIAGRAMS  
CAUTION  
Missing or illegible labels must be replaced, contact  
Precision Medical, Inc.  
PM5400 and PM5500 Models  
B
A
E
F
H
G
D
C
HELIO2  
BLENDEr  
HELIUM-OxygEn  
6
COMPONENT dESCRIPTION  
ITEM  
DESCRIPTION  
Oxygen Concentration dial  
A
Adial used for selecting oxygen concentrations between 20%  
-100% or 30% -100%. The FIO2 scale is used for reference  
only. The actual FIO2 must be verified with an Alarmed  
Oxygen Monitor / Analyzer.  
This dial does not rotate 360°. The dial starts at 20% or  
30% and ends at 100%.  
Primary Outlet Port  
A male DISS oxygen fitting with check valve that delivers flow  
when engaged to any controlling device, such as a flowmeter.  
B
C
Auxiliary Outlet Port  
Amale 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  
Auxiliary Bleed Collar  
d
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.  
To activate the bleed, slide and rotate the knurled collar back  
until it contacts the cover. To deactivate the bleed, pull and  
rotate collar away from cover until bleed flow valve is closed.  
Oxygen Inlet Fitting  
Afemale DISS or NIST oxygen fitting with one way valve that  
is used to connect an oxygen supply hose.  
E
F
Heliox Inlet Fitting  
A male DISS or NIST heliox fitting with one way valve that  
is used to connect a heliox supply hose.  
Alarm  
G
An audible alarm that sounds due to an excessive  
pressure drop or deletion of either gas supply.  
Rear Slide Mount with dove tail.  
H
HELIO2  
BLENDEr  
HELIUM-OxygEn  
7
PRE-USE TESTING  
WARNING  
Read this User Manual before installing or operating the HELIO2 Blender.  
• Confirm the concentration of heliox with an alarmed Oxygen Monitor /  
Analyzer.  
• Confirm contents of heliox cylinder prior to use.  
CAUTION  
Inspect the HELIO2 Blender for visual damage before use, DO NOT  
USE if damaged.  
NOTE: The tests listed below should be performed prior to placing the  
HELIO2 Blender in service.  
Pre-Use Testing consists of:  
Alarm Test  
• Reverse Gas Flow Procedure  
1. Secure the HELIO2 Blender to a wall or pole bracket in an upright position.  
2. Connect the heliox and oxygen supply lines to the appropriate inlet fittings  
on the bottom of the HELIO2 Blender.  
3. Attach a flowmeter, or other metering device to one of the outlet ports and  
verify FIO2 range for accuracy with an alarmed Oxygen Monitor / Analyzer.  
Primary Outlets Flow capacity:  
• High Flow Blender (PM 5500 Model) 15 lpm to 120 lpm  
• Low Flow Blender (PM 5400 Model) 3 lpm to 30 lpm  
Auxiliary Outlet Use:  
The auxiliary flow outlet maintains the same flow capacity and FIO2 accuracy  
as the Primary Outlets with Bleed Valve not engaged. When the bleed flow is  
activated, some of the heliox mixture will vent to atmosphere to maintain FIO2  
concentration accuracy at the low flow settings.  
High Flow Blender (PM 5500 Model) 15 lpm or less  
• Low Flow Blender (PM 5400 Model) 3 lpm or less  
4. Attach a supply line to the outlet port of the flowmeter.  
ALARM TEST  
1. Connect the HELIO2 Blender to respective heliox and oxygen sources,  
pressurize the Blender and turn “ON” the flowmeter.  
2. Set Oxygen Concentration Dial to 50% FIO2.  
3. Disconnect or turn “OFF” the heliox supply line to the HELIO2 Blender. The  
Blender should alarm with a loud whistle noise. The whistle indicates the  
alarm is operating correctly.  
4. Reconnect and activate the heliox supply line to the Blender, the alarm  
should stop whistling.  
5. Disconnect or turn “OFF” the oxygen supply line to the HELIO2 Blender.  
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.  
HELIO2  
7. If alarm fails to function properly, DO NOT USE.  
BLENDEr  
HELIUM-OxygEn  
8
REVERSE GAS FLOW PROCEdURE  
(CE Requirements ONLY)  
1. Assure bleed flow valve is not engaged. Disconnect the oxygen hose  
from the gas source. Remove all outlet connections from the HELIO2  
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 heliox 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 leakage is  
>100 ml/min. Reference HELIO2 Blender Service Manual (P/N 506124).  
4. Repeat steps 1-3 to check for leakage past the heliox inlet check  
valve.  
OPERATING INSTRUCTIONS  
CAUTION  
Inspect the HELIO2 Blender for visual damage before use,  
DO NOT USE if damaged.  
1. Secure Blender to wall or pole mount bracket.  
2. Connect heliox and oxygen supply lines from HELIO2 Blender to  
heliox cylinder and oxygen supply.  
3. Connect oxygen flowmeter to Blender outlet.  
4. Adjust the Oxygen Concentration Dial to the prescribed  
concentration. The balance of the concentration will be helium  
exiting the flowmeter.  
NOTE: The Oxygen Concentration Dial does not rotate 360°. dO  
NOT force dial beyond the oxygen concentration endpoints  
as this will damage the Blender.  
5. Confirm the flow of heliox mixture to the patient.  
6. Actual heliox concentration to the patient may vary due to  
entrainment of room air via the patient interface device.  
CAUTION  
Refer to “Oxygen Flowmeter Conversion Chart” for corrected  
heliox flows.  
• An oxygen flowmeter should be used on the outlets of the HELIO2  
Blender along with the corresponding flow conversion chart.  
• Actual flow from an oxygen flowmeter utilized to deliver heliox  
are higher than read on the flowmeter.  
HELIO2  
BLENDEr  
HELIUM-OxygEn  
9
7. Confirm the concentration of heliox with an Oxygen Monitor /  
Analyzer. If necessary activate the bleed flow valve to maintain  
FIO2 accuracy.  
8. To activate the bleed, turn and rotate the knurled collar back until it  
contacts the cover.  
9. To deactivate the bleed, pull and rotate the collar away from the  
cover until bleed flow valve is closed.  
10. Turn “OFF” the heliox and oxygen supply or disconnect when the  
HELIO2 Blender is not in use.  
CLEANING  
CAUTION  
dO NOT steam autoclave.  
dO NOT immerse the HELIO2 Blender into any liquid.  
dO NOT use any strong solvent or abrasive cleaners.  
dO NOT gas sterilize with (EtO) Ethylene Oxide.  
dO NOT clean with aromatic hydrocarbons.  
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 HELIO2 Blender must be performed  
by a trained service technician:  
The alarm should be tested prior to being placed into clinical  
service and periodically there after.  
• Every year conduct the Operational Verification Procedure (OVP).  
* A detailed description of the OVP tests can be found in the  
Blender Service Manual (P/N 506124), and available on the  
Every 2 years the HELIO2 Blender should be serviced.  
PM5400 (P/N 506125)  
PM5500 (P/N 506212)  
Refer to the HELIO2 Blender Service Manual (P/N 506124) for  
complete details regarding further maintenance and testing.  
HELIO2  
BLENDEr  
HELIUM-OxygEn  
10  
OxYGEN FLOWMETER CONVERSIONS  
Oxygen  
Flowmeter  
Corrected Heliox Flow (LPM) at Various FIO2 Settings  
Setting  
20%  
1.8  
30%  
1.6  
40%  
1.4  
50%  
1.3  
60%  
1.2  
70%  
1.18  
2.4  
80%  
1.15  
2.3  
90%  
1.02  
2.0  
100%  
1.0  
1
2
3.6  
3.2  
2.8  
2.6  
2.4  
2.0  
3
5.4  
4.8  
4.2  
3.9  
3.6  
3.5  
3.5  
3.1  
3.0  
4
7.2  
6.4  
5.6  
5.2  
4.8  
4.7  
4.6  
4.1  
4.0  
5
9.0  
8.0  
7.0  
6.5  
6.0  
5.9  
5.8  
5.1  
5.0  
6
10.8  
12.6  
14.4  
16.2  
18.0  
19.8  
21.6  
23.4  
25.2  
27.0  
28.8  
30.6  
32.4  
34.2  
36.0  
37.8  
39.6  
41.4  
43.2  
45.0  
46.8  
48.6  
50.4  
52.2  
54.0  
55.8  
57.6  
59.4  
61.2  
63.0  
64.8  
66.6  
68.4  
70.2  
72.0  
9.6  
8.4  
7.8  
7.2  
7.1  
6.9  
6.1  
6.0  
7
11.2  
12.8  
14.4  
16.0  
17.6  
19.2  
20.8  
22.4  
24.0  
25.6  
27.2  
28.8  
30.4  
32.0  
33.6  
35.2  
36.8  
38.4  
40.0  
41.6  
43.2  
44.8  
46.4  
48.0  
49.6  
51.2  
52.8  
54.4  
56.0  
57.6  
59.2  
60.8  
62.4  
64.0  
9.8  
9.1  
8.4  
8.3  
8.1  
7.1  
7.0  
8
11.2  
12.6  
14.0  
15.4  
16.8  
18.2  
19.6  
21.0  
22.4  
23.8  
25.2  
26.6  
28.0  
29.4  
30.8  
32.2  
33.6  
35.0  
36.4  
37.8  
39.2  
40.6  
42.0  
43.4  
44.8  
46.2  
47.6  
49.0  
50.4  
51.8  
53.2  
54.6  
56.0  
10.4  
11.7  
13.0  
14.3  
15.6  
16.9  
18.2  
19.5  
20.8  
22.1  
23.4  
24.7  
26.0  
27.3  
28.6  
29.9  
31.2  
32.5  
33.8  
35.1  
36.4  
37.7  
39.0  
40.3  
41.6  
42.9  
44.2  
45.5  
46.8  
48.1  
49.4  
50.7  
52.0  
9.6  
9.4  
9.2  
8.2  
8.0  
9
10.8  
12.0  
13.2  
14.4  
15.6  
16.8  
18.0  
19.2  
20.4  
21.6  
22.8  
24.0  
25.2  
26.4  
27.6  
28.8  
30.0  
31.2  
32.4  
33.6  
34.8  
36.0  
37.2  
38.4  
39.6  
40.8  
42.0  
43.2  
44.4  
45.6  
46.8  
48.0  
10.6  
11.8  
13.0  
14.2  
15.3  
16.5  
17.7  
18.9  
20.1  
21.2  
22.4  
23.6  
24.8  
26.0  
27.1  
28.3  
29.5  
30.7  
31.9  
33.0  
34.2  
35.4  
36.6  
37.8  
38.9  
40.1  
41.3  
42.5  
43.7  
44.8  
46.0  
47.2  
10.4  
11.5  
12.7  
13.8  
15.0  
16.1  
17.3  
18.4  
19.6  
20.7  
21.9  
23.0  
24.2  
25.3  
26.5  
27.6  
28.8  
29.9  
31.1  
32.2  
33.4  
34.5  
35.7  
36.8  
38.0  
39.1  
40.3  
41.4  
42.6  
43.7  
44.9  
46.0  
9.2  
9.0  
10  
11  
12  
13  
14  
15  
16  
17  
18  
19  
20  
21  
22  
23  
24  
25  
26  
27  
28  
29  
30  
31  
32  
33  
34  
35  
36  
37  
38  
39  
40  
10.2  
11.2  
12.2  
13.3  
14.3  
15.3  
16.3  
17.3  
18.4  
19.4  
20.4  
21.4  
22.4  
23.5  
24.5  
25.5  
26.5  
27.5  
28.6  
29.6  
30.6  
31.6  
32.6  
33.7  
34.7  
35.7  
36.7  
37.7  
38.8  
39.8  
40.8  
10.0  
11.0  
12.0  
13.0  
14.0  
15.0  
16.0  
17.0  
18.0  
19.0  
20.0  
21.0  
22.0  
23.0  
24.0  
25.0  
26.0  
27.0  
28.0  
29.0  
30.0  
31.0  
32.0  
33.0  
34.0  
35.0  
36.0  
37.0  
38.0  
39.0  
40.0  
HELIO2  
BLENDEr  
HELIUM-OxygEn  
11  
TECHNICAL dESCRIPTION  
For a complete Technical Description of the HELIO2 Blender and  
list of Replacement Parts, reference the HELIO2 Blender Service  
Manual (P/N 506124) 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  
HELIO2  
BLENDEr  
HELIUM-OxygEn  
12  
TROUBLESHOOTING  
If the HELIO2 Blender fails to function, consult the Troubleshooting  
Guide below.  
If problem cannot be solved by using Troubleshooting Guide, refer to the  
HELIO2 Blender Service Manual (P/N 506124) available on the Internet;  
Problem  
Probable Cause  
Remedy  
1. •HIgH flow model,  
flow requirement  
below 15 lpm.  
1. Use auxiliary outlet &  
engage bleed  
Oxygen  
concentration  
discrepancy  
between Blender  
setting and  
alarmed Oxygen  
Monitor / Analyzer  
(greater than 3%)  
LOW flow model,  
flow requirement  
below 3 lpm.  
2. Recalibrate alarmed  
Oxygen Monitor /  
Analyzer or Verify  
with second alarmed  
Oxygen Monitor /  
Analyzer  
2. Alarmed Oxygen  
Monitor / Analyzer  
inaccurate  
3. Remove obstruction  
3. Low flow bleed  
obstructed  
4. Check gas sources  
with calibrated alarmed  
Oxygen Monitor /  
4. Gas supply  
contaminated or  
heliox concentration  
incorrect  
Analyzer to confirm  
oxygen is 100% and  
verify heliox tank content  
5. Isolate Blender. Check  
oxygen concentration at  
Blender Outlets  
6. Assure heliox and  
oxygen inlets pressures  
are within 10 psi  
5. Downstream device  
causing back flow  
or restricted flow  
6. Supply pressure  
imbalanced  
1. Gas sources turned 1. Turn gas sources “ON”  
“OFF”  
No flow at  
Blender outlets  
2. Gas sources not  
connected  
2. Connect gas sources  
1. Difference between  
oxygen and heliox  
inlet pressures  
1. Correct pressure  
Alarm sounding  
difference until heliox  
and oxygen pressures  
are within specification  
greater than specified  
HELIO2  
BLENDEr  
HELIUM-OxygEn  
13  
LIMITEd WARRANTY  
ANd  
LIMITATION OF LIABILITY  
PrecisionMedical,Inc.warrantsthattheHeliO2Blender,(theProduct),will  
be free of defects in workmanship and/or material for the following period:  
Two (2) years from shipment  
Should any failure to conform to this warranty appear within the applicable  
period, Precision Medical, Inc. shall, upon written notification thereof and  
substantiation that the goods have been stored, installed, maintained and  
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 WARRANTYIS ExCLUSIVEAND IS IN LIEU OFANYWARRANTY  
OF MERCHANTABILITY, FITNESS FORAPARTICULAR PURPOSE OR  
OTHERWARRANTYOFQUALITY,WHETHERExPRESSORIMPLIED.  
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.  
HELIO2  
BLENDEr  
HELIUM-OxygEn  
14  
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 (European Office)  
Molenstraat 15  
2513 BH, The Hague  
The Netherlands  
Phone: +31 (0) 70.345.8570  
Fax: +31 (0) 70.346.7299  
Product:  
Gas Mixers for Medical Use (Blender)  
PM5470EN, PM5480EN, PM5570EN, PM5580EN  
IIb  
Model(s):  
MDD Class:  
Classification criteria:  
Clause 3.2 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  
Edition  
EN 980  
2008  
EN 1041  
2008  
ISO 11198  
ISO 14971  
ISO 15001  
1995  
2007 2nd Ed  
2004  
ISO 7000  
2004  
Notified Body:  
TÜV Rheinland Products Safety GmbH  
EC Certificate No.: HD60019110 0001  
ISO 13485 Certified  
505963 Rev3 (E) 04/05/10 Printed in USA  

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