Helio Pm5400 Users Manual

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2015-02-09

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USER MANUAL

HELIO2
HELIUM-Oxygen Blender

(DISS and NIST Connections)
Model No. PM5400 Series (shown)
PM5500 Series

SAVE THESE INSTRUCTIONS

CAUTION

Federal (USA) law restricts this device to sale
by or on the order of a physician.

300 Held Drive
Tel: (+001) 610-262-6090
Northampton, PA 18067 USA
Fax: (+001) 610-262-6080
www.precisionmedical.com

Contents

RECEIVING / INSPECTION.................................................................1
Intended Use...................................................................................1
READ ALL INSTRUCTIONS BEFORE USING....................................1
Explanation of Abbreviations.................................................2
SAFETY Information - Warnings and Cautions...................2
Specifications . .............................................................................4
Diagrams..........................................................................................6
COMPONENT Description.............................................................7
Alarm Test.......................................................................................8
Reverse Gas Flow Procedure................................................9
OPERATING INSTRUCTIONS.............................................................9
CLEANING.........................................................................................10
Maintenance.................................................................................10
Oxygen flowmeter conversions......................................... 11
Technical Description..............................................................12
Returns..........................................................................................12
Disposal Instructions..............................................................12
Troubleshooting.......................................................................13
LIMITED WARRANTY........................................................................14

RECEIVING / INSPECTION

Remove the Precision Medical, Inc. HELIO2 (Helium-Oxygen) Blender from the
packaging and inspect for damage. If there is any damage, DO NOT USE and
contact your Provider.

Intended Use

The Precision Medical, Inc. Helium and Oxygen Blender is designed to dispense
a continuous and precise blend of Medical Helium and Oxygen via outlet ports to
infant, pediatric and adult patients. The exact FIO2 blend of gases corresponds
to the dialed in Fractional Concentration of Oxygen (FIO2 ) setting indicated by
the control face. Oxygen concentrations can be dialed in from 20% to 100% for
heliox tank mixtures of 20% oxygen / 80% helium, and 30% to 100% for heliox
tank mixtures of 30% oxygen / 70% helium. The Helium and Oxygen Blender is
a restricted medical device intended for use by qualified and trained personnel
under the direction of a physician in institutional environments where delivery
and monitoring of helium/oxygen mixture is required.
The Blender is not intended as a life supporting device.
HELIO2
Blender

HELIUM-Oxygen

1

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
FIO2

Fractional Concentration of Inspired Helium-Oxygen
Fractional Concentration of Inspired Oxygen

Heliox
DISS
NIST
psi
lpm

Helium-Oxygen
Diameter Indexed Safety System
Non-Interchangeable Screw Thread
Pounds Per Square Inch
Liters Per Minute

SAFETY Information - Warnings and Cautions
DANGER
WARNING
CAUTION
CAUTION

Indicates an imminently hazardous situation which,
if not avoided, will result in death or serious injury.
Indicates a potentially hazardous situation which, if
not avoided, could result in death or serious injury.
Indicates a potentially hazardous situation which, if
not avoided, may result in minor or moderate injury.
Used without the safety alert symbol indicates a
potentially hazardous situation which, if not avoided,
may result in property damage.
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
2

HELIO2
Blender

HELIUM-Oxygen

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
Model
Primary Outlet
Flow Range

High Flow

Low Flow

PM5580: 80/20 heliox
PM5570: 70/30 heliox

PM5480: 80/20 heliox
PM5470: 70/30 heliox

15 - 120 lpm

3 - 30 lpm

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

Bleed Flow @
100% FIO2
Maximum
Combined
Flow (All Outlets)
Bypass Flow
(Loss of Helium or
Oxygen supply)
Bypass Alarm
Activation

13 lpm or less
at 50 psi (3.4 bar)

3 lpm or less
at 50 psi (3.4 bar)

≥ 120 lpm

≥ 30 lpm

> 85 lpm

> 45 lpm

50 psi
(3.45 bar)

60 psi
(4.14 bar)

50 psi
(3.45 bar)

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

Alarm Reset:

When pressure differential is 6 psi (0.4 bar)
or less.
≥ to 80 db at 1 ft (0.3 m)

Alarm Sound Level:
Oxygen Concentration PM5480
Adjustment Range:
PM5580

20 100%

PM5470
30 - 100%
PM5570

Gas Supply Pressure: 30 - 75 psi (2.1 - 5.2 bar) Heliox & Oxygen
Mixed Gas Stability:
Connection Types:

within 10 psi (0.69 bar) of each other

±1% Oxygen
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).

4

HELIO2
Blender

HELIUM-Oxygen

Specifications continued
Dimensions: (without fittings)
	
Depth:	
Width:	
	
Height:	
	
Weight:	
Shipping Weight:	
Operating Temperature Range:

4.9 in

	

(12.5 cm)

2.3 in

	

(5.7 cm)

4.1 in
2.9 lbs

	
	

(10.4 cm)
(1.3 kg)

3.5 lbs

	

(1.6 kg)

59°F to 104°F (15°C to 40°C)

Transport / Storage Requirements
Temperature Range:
Humidity:
FIO2 Accuracy:*

-10°F to 140°F (-23°C to 60°C)
Max 95% Noncondensing
± 3% of full scale @ 50 psi (3.4 bar)

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:
Oxygen:

Medical grade 80/20 or 70/30 is required.
Oxygen supply must meet all requirements of USP
Medical Oxygen.
Dew Point: Both inlets should remain 10°F (-12.2°C) or more
(ONLY for CE below the lowest temperature to which the air
requirements) 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.
* 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

C

G

D

6

HELIO2
Blender

HELIUM-Oxygen

COMPONENT Description

ITEM	
DESCRIPTION
Oxygen Concentration Dial
A

B
C

D

	A dial 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.
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	
Flow Range
2 - 100 lpm
High Flow	
Low Flow	
0 - 30 lpm
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.
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.

E

Oxygen Inlet Fitting
	A female DISS or NIST oxygen fitting with one way valve that
is used to connect an oxygen supply hose.

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
An audible alarm that sounds due to an excessive
pressure drop or deletion of either gas supply.
Rear Slide Mount with dove tail.

G
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
Internet; www.precisionmedical.com
•	 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.

10

HELIO2
Blender

HELIUM-Oxygen

Oxygen flowmeter conversions
Oxygen
Flowmeter
Setting

20%

30%

40%

50%

60%

70%

80%

90%

100%

1

1.8

1.6

1.4

1.3

1.2

1.18

1.15

1.02

1.0

2

3.6

3.2

2.8

2.6

2.4

2.4

2.3

2.0

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

9.6

8.4

7.8

7.2

7.1

6.9

6.1

6.0

7

12.6

11.2

9.8

9.1

8.4

8.3

8.1

7.1

7.0

8

14.4

12.8

11.2

10.4

9.6

9.4

9.2

8.2

8.0

9

16.2

14.4

12.6

11.7

10.8

10.6

10.4

9.2

9.0

10

18.0

16.0

14.0

13.0

12.0

11.8

11.5

10.2

10.0

Corrected Heliox Flow (LPM) at Various FIO2 Settings

11

19.8

17.6

15.4

14.3

13.2

13.0

12.7

11.2

11.0

12

21.6

19.2

16.8

15.6

14.4

14.2

13.8

12.2

12.0

13

23.4

20.8

18.2

16.9

15.6

15.3

15.0

13.3

13.0

14

25.2

22.4

19.6

18.2

16.8

16.5

16.1

14.3

14.0

15

27.0

24.0

21.0

19.5

18.0

17.7

17.3

15.3

15.0

16

28.8

25.6

22.4

20.8

19.2

18.9

18.4

16.3

16.0

17

30.6

27.2

23.8

22.1

20.4

20.1

19.6

17.3

17.0

18

32.4

28.8

25.2

23.4

21.6

21.2

20.7

18.4

18.0

19

34.2

30.4

26.6

24.7

22.8

22.4

21.9

19.4

19.0

20

36.0

32.0

28.0

26.0

24.0

23.6

23.0

20.4

20.0

21

37.8

33.6

29.4

27.3

25.2

24.8

24.2

21.4

21.0

22

39.6

35.2

30.8

28.6

26.4

26.0

25.3

22.4

22.0

23

41.4

36.8

32.2

29.9

27.6

27.1

26.5

23.5

23.0

24

43.2

38.4

33.6

31.2

28.8

28.3

27.6

24.5

24.0

25

45.0

40.0

35.0

32.5

30.0

29.5

28.8

25.5

25.0

26

46.8

41.6

36.4

33.8

31.2

30.7

29.9

26.5

26.0

27

48.6

43.2

37.8

35.1

32.4

31.9

31.1

27.5

27.0

28

50.4

44.8

39.2

36.4

33.6

33.0

32.2

28.6

28.0

29

52.2

46.4

40.6

37.7

34.8

34.2

33.4

29.6

29.0

30

54.0

48.0

42.0

39.0

36.0

35.4

34.5

30.6

30.0

31

55.8

49.6

43.4

40.3

37.2

36.6

35.7

31.6

31.0

32

57.6

51.2

44.8

41.6

38.4

37.8

36.8

32.6

32.0

33

59.4

52.8

46.2

42.9

39.6

38.9

38.0

33.7

33.0

34

61.2

54.4

47.6

44.2

40.8

40.1

39.1

34.7

34.0

35

63.0

56.0

49.0

45.5

42.0

41.3

40.3

35.7

35.0

36

64.8

57.6

50.4

46.8

43.2

42.5

41.4

36.7

36.0

37

66.6

59.2

51.8

48.1

44.4

43.7

42.6

37.7

37.0

38

68.4

60.8

53.2

49.4

45.6

44.8

43.7

38.8

38.0

39

70.2

62.4

54.6

50.7

46.8

46.0

44.9

39.8

39.0

40

72.0

64.0

56.0

52.0

48.0

47.2

46.0

40.8

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;
www.precisionmedical.com.

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
Internet; www.precisionmedical.com.

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

12

HELIO2
Blender

HELIUM-Oxygen

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;
www.precisionmedical.com or consult your Provider.

Problem
Oxygen
concentration
discrepancy
between Blender
setting and
alarmed Oxygen
Monitor / Analyzer
(greater than 3%)

Probable Cause
1. •HIGH flow model,
flow requirement
below 15 lpm.
•LOW flow model,
flow requirement
below 3 lpm.
2. Alarmed Oxygen
Monitor / Analyzer
inaccurate

Remedy
1. Use auxiliary outlet &
engage bleed

2. Recalibrate alarmed
Oxygen Monitor /
Analyzer or Verify
with second alarmed
Oxygen Monitor /
Analyzer
3. Remove obstruction

3. Low flow bleed
obstructed
4. Check gas sources
4. Gas supply
with calibrated alarmed
contaminated or
Oxygen Monitor /
heliox concentration
Analyzer to confirm
incorrect
oxygen is 100% and
verify heliox tank content
5. Downstream device 5. Isolate Blender. Check
oxygen concentration at
causing back flow
Blender Outlets
or restricted flow
6. Assure heliox and
6. Supply pressure
oxygen inlets pressures
imbalanced
are within 10 psi

No flow at
Blender outlets

1. Gas sources turned
“OFF”
2. Gas sources not
connected

Alarm sounding

1. Difference between
1. Correct pressure
oxygen and heliox
difference until heliox
inlet pressures
and oxygen pressures
greater than specified
are within specification

HELIO2
Blender

HELIUM-Oxygen

13

1. Turn gas sources “ON”
2. Connect gas sources

LIMITED WARRANTY
AND
LIMITATION OF LIABILITY

Precision Medical, Inc. warrants that the HeliO2 Blender, (the Product), 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 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 nonconformities 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.

14

HELIO2
Blender

HELIUM-Oxygen

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)

Model(s):	

PM5470EN, PM5480EN, PM5570EN, PM5580EN

MDD Class:	

IIb

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	

1995

ISO 14971	

2007 2nd Ed

ISO 15001	

2004

ISO 7000	
Notified Body:	

2004
TÜV Rheinland Products Safety GmbH

EC Certificate No.:	 HD60019110 0001

www.precisionmedical.com

ISO 13485 Certified



505963 Rev3 (E) 04/05/10 Printed in USA



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