Respironics UltraFill User Manual

1065704

1070161 R05

LZ 3/19/2013

USER MANUAL

MANU EL DE L’UTILIS ATEUR

MANUA L DEL USUARIO

UltraFill User Manual

Table of Contents

Introduction .............................................................................................3

How the System Works .........................................................................7

Troubleshooting Guide ....................................................................... 19

Cleaning and Maintenance ................................................................. 22

Transporting the UltraFill System ..................................................... 22

Specications ......................................................................................... 23

EMC Information .................................................................................. 25

Limited Warranty ................................................................................. 27

Bonsai is a registered trademark of CHAD Therapeutics.

Symbol Key

Follow Instructions For Use Keep Away From Open Flames

Keep Well Ventilated Keep Away From Electrical Appliances

No Smoking Keep Away From Oil Or Grease

AC Power Keep Unit Upright

Type B Applied Part Class II Device

CAUTION: US federal law restricts this device to sale by or on the order of a physician.

Drip Proof Equipment

System warning System fault

Follow instructions for maintaining stability of the equipment.

Denitions

The following denitions and acronyms are used in this manual:

• lpm liters per minute

• dBA decibels

• CGA Compressed Gas Association

• OPI Oxygen Percent Indicator

• OCD Oxygen Conserving Device

• CF Continuous Flow

UltraFill User Manual

IntroductIon

Intended Use

The intended use of the UltraFill System is to provide supplemental oxygen to patients and to supply pressurized

oxygen to ll cylinders for the patients' personal ambulatory use. The device is not intended to be life supporting or

life sustaining.

Device Description

The UltraFill System is comprised of an oxygen lling station, a compatible oxygen concentrator, one or more oxygen

cylinder(s) and an oxygen conserving device or regulator.

While the UltraFill is lling a cylinder, a 5-liter concentrator will provide patient ow up to a maximum of 3 lpm and ll the cylinder continuously. The UltraFill cannot be used with a 5-liter concentrator when the required patient ow is greater than 3 lpm. When the required patient ow is greater than 3 lpm, the Millennium M10 concentrator will provide ow up to a maximum of 7 lpm.

Warnings & Cautions

CAUTION: US federal law restricts this device to sale by or on the order of a physician.

Warnings

• If while using the system you experience any discomfort or signs of any unusual physical symptoms, contact your

physician immediately.

• Oxygen can promote rapid burning when exposed to an open flame. Do not allow any smoking objects or open flames near this unit.

• Do not use any oil, grease, or petroleum-based products on or near this unit.

• Do not smoke while the device is in use.

• Protect the device against the spillage of fluids on or around it. Do not place drinks on it. Do not allow fluids to come in contact with the device. If fluids do come in contact with the device, contact your service representative.

• Do not set any objects on, or allow to be draped over, the UltraFill Station as they might block air flow into the

device. Place the unit in a ventilated location with the sides and rear two feet away from any object.

• Do not allow minors or children to operate the UltraFill System. Do not allow unsupervised children to play on or near the device.

• To prevent an accidental tip over, do not attempt to move the UltraFill when it is connected to a cylinder.

• Do not use the UltraFill System if either the plug or power cord is damaged. Do not use an extension cord with the UltraFill System.

• Do not connect the UltraFill System to an electrical outlet controlled by a wall switch or ground fault interruptor. Make sure there is no other high power device such as a TV, stereo, computer, radio transmitter, space heater, hair dryer, refrigerator, microwave oven, electrical range, or other large appliance connected to this outlet.

• Electrical shock hazard: Do not remove the cabinet of the UltraFill Station. The removal of the cabinet should only be performed by Respironics, Inc. or a trained representative.

• Disconnect the power cord from the electrical outlet before cleaning the housing of the UltraFill Station.

• This equipment complies with IEC 60601-1-2 for electromagnetic compatibility for medical electrical equipment

and/or systems. This standard is designed to provide reasonable protection against harmful interference in a

typical medical installation. However, because of the proliferation of radio-frequency transmitting equipment and other sources of electrical noise in health care and other environments, it is possible that high levels of such

interference due to close proximity or strength of a source might disrupt the performance of this device. Medical

electrical equipment needs special precautions regarding EMC, and all equipment must be installed and put into

service according to the EMC information specified in this manual.

• Take precautions to prevent electrostatic discharge (ESD). Precautionary procedures include methods to prevent buildup of electrostatic discharge (e.g., air conditioning, humidification, conductive floor coverings, and nonsynthetic clothing), discharging one’s body to the frame of the equipment or system or to earth or a large metal object, and bonding oneself by means of a wrist strap to the equipment or system, or to earth.

• All cylinders must be inspected before attempting to fill. Otherwise, injury or damage may occur.

• Do not fill cylinders that have not been tested in the past 5 years. Otherwise, serious personal injury may result.

Contact your dealer for replacement.

• Never use tools of any kind to disconnect the cylinder from the UltraFill Station. Otherwise, severe injury and/or

damage may occur.

• Do not drop oxygen cylinders. Use two hands when handling/transporting oxygen cylinders. Otherwise, injury or

damage may occur.

• Do not use a liquid leak detector to test for leaks.

• Do not direct the flow of oxygen at any person or flammable material when adjusting the flow.

• When the pointer on the cylinder contents gauge enters the red zone, it is recommended to refill the cylinder.

• No oxygen is delivered between cylinder settings. To obtain desired flow, the indicating pointer must align with a

specific number on the dial.

• To avoid injury to the patient, always confirm prescribed setting before administering to the patient.

UltraFill User Manual

Cautions

• Do not use cleaning solutions.

• Do not immerse the cylinders in any kind of liquid.

Additional warnings, cautions and notes are located throughout this manual.

Compatibility with Oxygen Devices

The UltraFill Home Oxygen Filling Station is compatible with the following devices:

Concentrators

Respironics EverFlo Stationary Oxygen Concentrator

Respironics EverFlo Q Stationary Oxygen Concentrator

Respironics Millennium M600 and M605 Series Concentrator

Respironics Millennium M10 Concentrator

Cylinders

Respironics UltraFill 2000 PSI (135 bar) Oxygen Cylinders:

• M4 • MD15

• M6 • ME24

• M9

Respironics UltraFill 3000 PSI (200 bar) Oxygen Cylinders:

• MB08 • MD22

• MC13 • ME36

Oxygen Conserving Devices and Regulators

• CHAD Therapeutics Bonsai®

• CHAD Therapeutics 4800 Regulator

• CHAD Therapeutics 3100 Regulator

• CHAD Therapeutics 3100 Pediatric Regulator

Note: UltraFill 2000 psi (135 bar) and 3000 psi (200 bar) cylinders are equipped to connect to any CGA-870 compatible

conserving devices and regulators. It is important to ensure the conserving device or regulator has been designed, manufactured, and tested for use at the pressure rating of the cylinder. The CHAD Therapeutics 3100 Regulator and Bonsai Conserving Device offered by Respironics have been designed, manufactured and tested for use on both 2000 psi (135 bar) and 3000 psi (200 bar) cylinders.

Accessories

• Cylinder Carry Bag (Small: M9/MC13; Medium: M4/M6/MB08; Large: MD15/MD22)

• Cylinder Carry Cart (For Cylinder Sizes: MD15/MD22/ME24/ME36)

• Cylinders

» 2000 PSI (135 bar): M4, M6, M9, MD15, ME24 » 3000 PSI (200 bar): MB08, MC13, MD22, ME36

• CHAD Therapeutics Bonsai

• CHAD Therapeutics 4800 Regulator

• CHAD Therapeutics 3100 Regulator

• CHAD Therapeutics 3100 Pediatric Regulator

How to Contact Respironics

To have your device serviced, contact your home care provider. If you need to contact Respironics directly, call the Respironics Customer Service department at 1-800-345-6443 (US and Canada only) or 1-724-387-4000. You can also use the following address:

Respironics, Inc. 1001 Murry Ridge Lane Murrysville, PA 15668 USA

UltraFill User Manual

How tHe SyStem workS

The UltraFill Home Oxygen Filling Station lls Respironics oxygen cylinders with gaseous oxygen supplied from an

oxygen concentrator.

The UltraFill Station is attached to the concentrator via a pneumatic tube. The oxygen concentrator takes room air and feeds oxygen enriched air to the UltraFill. The UltraFill compresses oxygen into a cylinder at a very high pressure.

This cylinder can then be used for ambulatory oxygen. While the cylinder is lling you can continue to breathe from a 5-liter concentrator at ow rates up to 3 LPM and a 10-liter concentrator at ow rates up to 7 LPM.

The UltraFill Station is only used for lling a cylinder. You cannot breathe oxygen gas directly from it. This device is not

intended to be life supporting or life sustaining.

To ensure the correct use of this device, please read the information in this manual carefully before trying to operate this device. After reading this manual, keep it in a safe place where you can refer to it any time a question arises.

Getting Started

Begin by becoming familiar with your UltraFill and the Control Panel.

Front View

Rear View

Top View

Control

Panel

Cylinder Rest

Oxygen Cylinder Connector

Cylinder Connection Cover

Cylinder Release Button

Handle

Pocket for Tubing Storage

Tubing Connection

Control Panel

Cylinder Release Button

Oxygen Cylinder Connector

Hour Meter

Cylinder Rest

Handle

Cord

Connection

Control Panel

Description Color Function

Power Button Power Off –

None Power On – Green

When the switch is turned so that the “I” symbol is down, the

device is operational.

System Warning

Yellow When lit, this indicates the device has detected a possible fault.

The audible alarm may or may not be sounding.

System Fault Red When lit, this indicates the device has detected a fault that may

require service by the provider. The audible alarm will sound. The device may stop lling and might not begin lling again until

the problem is corrected.

Power

Button

Power On –

Green Light

Fill Level Indicators

Start/Stop Fill Button

System Warning

– Yellow Light

System Fault –

Red Light

Cylinder Release Button

UltraFill User Manual

Description Color Function

Fill Level Indicator

Blue When at least one segment is lit, it indicates that the cylinder is

connected properly to the device.

When one segment is blinking, the cylinder is currently lling. Each solid lit segment represents 25% of the cylinder ll

volume.

When all four segments are steadily lit, the cylinder is full and

can be disconnected from the device.

Start/Stop Fill Button

Black When pressed, the device will start or stop the cylinder ll

process.

Cylinder Release Button

Blue When pressed, the cylinder will be disconnected from the

device.

Using the UltraFill System

Initial Setup

1. Place the UltraFill system in an appropriate area (see the Specification section of this manual).

2. Place the UltraFill in a room with adequate ventilation. The sides and rear of the device must be at least 24 inches away from any object.

3. Plug the UltraFill in to a standard 120V outlet. Do not connect the UltraFill System to an electrical outlet controlled by a wall switch or ground fault interruptor. Make sure that no other high power device such as a

TV, stereo, computer, refrigerator, microwave oven, electrical range, or other large appliance is connected to this

outlet.

Connecting an Oxygen Concentrator

Warning: to prevent an accidental tip over, do not attempt to move the UltraFill when it is connected to a cylinder.

Note: the oxygen concentrator used with the UltraFill System may look different from the illustration.

1. Ensure that one end of the tubing is connected to the transfill outlet connection.

2. Connect the other end of the tubing to the concentrator outlet connection.

005 23

Concentrator Tubing Connection

Transfill Tubing Connection

UltraFill User Manual

Examining the Cylinder

Before using and/or lling the cylinder:

1. Examine the outside of the cylinder for the following:

» dents or dings » oil or grease » any other signs that the cylinders may be unsafe for use

2. Check the cylinder for fire or thermal damage.

3. Examine the cylinder fill connector for:

» debris, oil or grease » noticeable signs of damage » signs of excessive heat or fire damage » signs of corrosion inside the valve

If any of the above conditions exist, call your homecare provider to replace the cylinder.

Connecting the Cylinder

Before connecting the cylinder:

1. Make sure the UltraFill is plugged in and the concentrator is turned on.

Note: allow the concentrator to warm up for 5 minutes prior to lling a cylinder.

2. Press the power button to turn on the UltraFill. The green, yellow and red level indicator lights will flash and the system will beep. Then the yellow and red level indicators will turn off and the green level indicator light will be solid.

3. Check to see that the OCD or regulator is set to “OFF”.

Note: if lling the cylinder without an OCD or regulator attached, please close the cylinder valve to ensure the cylinder lls

properly.

o

Flow Dial

To connect the cylinder:

1. Remove the protective caps from the oxygen cylinder connector and cylinder fill connector.

2. Line up and place the cylinder fill connector inside the oxygen cylinder connector.

3. Lightly push the cylinder in to the oxygen cylinder connector.

UltraFill User Manual

Filling a Cylinder

Once the cylinder is properly connected, you can start the ll process.

1. Press the stop/start button.

2. As the oxygen cylinder fills, the level indicators on the UltraFill will illuminate. The first level indicator blinks while

the oxygen cylinder is filling, then turns solid when the device is 25% full. As the oxygen cylinder continues to fill, each level indicator will blink, then illuminate.

3. When the cylinder is full, all level indicators will be solid. The UltraFill will automatically turn off and the cylinder can be disconnected.

Note: the cylinder can be removed before it is completely full. Simply follow the steps outlined in the section called

“Disconnecting Cylinder”.

Note: if the yellow LED is lit continuously and the red LED is ashing with a constant audible alarm, the O2 purity in the

cylinder has dropped below 90%. Remove and empty the cylinder (see the sections of this manual called “Disconnecting a Cylinder and “Emptying a Cylinder”). Refer to the “Troubleshooting Guide” in this manual for more information. If the problem persists, contact your homecare provider.

Cylinder Size Volume (L) Typical Fill Times

2000 psi (135 bar) M4 103 45 min M6 148 1 hr 5 min M9 246 1 hr 50 min MD15 413 3 hr 5 min ME24 679 5 hr 3000 psi (200 bar) MB08 232 1 hr 45 min MC13 354 2 hr 35 min MD22 604 4 hr 25 min ME36 992 7 hr 20 min

Disconnecting a Cylinder

1. Press the cylinder release button on the control panel. The cylinder will disconnect and the fill level indicators will turn off.

2. Remove the cylinder from the oxygen cylinder connector.

To ll additional cylinders, repeat the previous steps. If you are nished lling cylinders, replace the oxygen ll

connector covers on the UltraFill and cylinders.

1 2

UltraFill User Manual

Emptying a Cylinder

If the O2 purity in the cylinder has dropped below 90%, the cylinder will need to be emptied.

To empty your O2 cylinder, adjust your conserving device or regulator to the highest continuous ow setting and

wait for it to empty. After the cylinder has been emptied, it can be relled again (Please see the section on Filling a

Cylinder).

Flow Dial set to

Continuous Flow (CF)

Cannula Port

Cylinder Gauge

Breathing from the Cylinder

To use the cylinder, follow the steps below.

1. Prior to use, inspect the cylinder for any visible damage. If there is damage, do not use the cylinder.

2. Make sure the cylinder is filled with oxygen. If not, refill it using the UltraFill. See the section titled Filling the Cylinder for instructions on how to check the oxygen level and refill the cylinder.

3. If the conserving device or regulator has not already been attached, please place it on the cylinder (see

illustration below) and open the cylinder post-valve.

» Find the CGA-870 connection on the OCD/regulator and match it to the connection on the cylinder (3a). » Find the CGA-870 connection on the cylinder and attach the OCD/regulator (3b). » Turn and tighten the knob on the right to secure the OCD/regulator position on the cylinder (3c).

4. Connect a standard single lumen nasal cannula to the cannula barb. Make sure the cannula tubing is no longer than 7 ft (2.1 m).

5. Confirm that the conserving device or regulator is set to the appropriate position as prescribed by your physician.

6. Adjust the cannula around your face so it fits correctly and comfortably. Breathe normally.

7. When the cylinder is not in use, turn the OCD or regulator control to the OFF position.

UltraFill User Manual

Cylinder Use Times

The pulse dose will vary on each individual’s breathing patterns. The use time will vary depending on the patient’s prescription, breath rate and type of conserving device being used. All use times are calculated using a setting of 2 and at a breath rate of 20-breaths per minute for pulse dose.

Respironics will offer both an oxygen conserving device (CHAD Therapeutics Bonsai) and two regulators (CHAD

Therapeutics 4800 and 3100) with our system package. The use times are calculated below:

Duration (at Bonsai Settings)

Volume (L)

1 2 3 4 5 6 7 2 lpm

Cylinder Type

M4 103 6 hr

26 min

3 hr 51 min

2 hr 45 min

2 hr 9 min

1 hr 53 min

1 hr 43 min

1 hr 27 min

52 min

M6 148 9 hr

15 min

5 hr 33 min

3 hr 57 min

3 hr 5 min

2 hr 43 min

2 hr 28 min

2 hr 6 min

1 hr 14 min

M9 246 15 hr

23 min

9 hr 14 min

6 hr 34 min

5 hr 8 min

4 hr 31 min

4 hr 6 min

3 hr 29 min

2 hr 3 min

MD15 413 25 hr

48 min

15 hr 29 min

11 hr 1 min

8 hr 36 min

7 hr 34 min

6 hr 53 min

5 hr 51 min

3 hr 27 min

ME24 679 42 hr

26 min

25 hr 28 min

18 hr 6 min

14 hr 9 min

12 hr 27 min

11 hr 19 min

9 hr 37 min

5 hr 40 min

MB08 232 14 hr

30 min

8 hr 42 min

6 hr 11 min

4 hr 50 min

4 hr 15 min

3 hr 52 min

3 hr 17 min

1 hr 56 min

MC13 354 22 hr

8 min

13 hr 17 min

9 hr 26 min

7 hr 23 min

6 hr 29 min

5 hr 54 min

5 hr 1 min

2 hr 57 min

MD22 604 37 hr

45 min

22 hr 39 min

16 hr 6 min

12 hr 35 min

11 hr 4 min

10 hr 4 min

8 hr 33 min

5 hr 2 min

ME36 992 62 hr 37 hr

12 min

26 hr 27 min

20 hr 40 min

18 hr 11 min

16 hr 32 min

14 hr 3 min

8 hr 16 min

Duration (CF Settings)

Regulator Volume

(L)

.5 1 2 3 4 5 6 8 10 12 15

Cylinder Type

M4 103 3 hr

26 min

1 hr 43 min

51 min 34 min 26 min 21 min 17 min 13 min 10 min 9 min 7 min

M6 148 4 hr

56 min

2 hr

28 min

1 hr 14 min

49 min 37 min 30 min 25 min 19 min 15 min 12 min 10 min

M9 246 8 hr

12 min

4 hr

6 min

2 hr 3 min

1 hr 22 min

1 hr 2 min

49 min 41 min 31 min 25 min 21 min 16 min

MD15 413 13 hr

46 min

6 hr

53 min

3 hr

26 min

2 hr

18 min

1 hr 43 min

1 hr 23 min

1 hr 9 min

52 min 41 min 34 min 28 min

ME24 679 22 hr

38 min

11 hr 19 min

5 hr 39 min

3 hr

46 min

2 hr

50 min

2 hr

16 min

1 hr 53 min

1 hr 25 min

1 hr

8 min

57 min 45 min

MB08 232 7 hr

44 min

3 hr 52 min

1 hr

56 min

1 hr 17 min

58 min 46 min 39 min 29 min 23 min 19 min 16 min

MC13 354 11 hr

48 min

5 hr 54 min

2 hr 57 min

1 hr

58 min

1 hr 29 min

1 hr 11 min

59 min 44 min 35 min 30 min 24 min

MD22 604 20 hr

8 min

10 hr

4 min

5 hr 2 min

3 hr 21 min

2 hr 31 min

2 hr 1 min

1 hr 41 min

1 hr

16 min

1 hr 50 min 40 min

ME36 992 33 hr

4 min

16 hr

32 min

8 hr 16 min

5 hr 31 min

4 hr

8 min

3 hr

18 min

2 hr 45 min

2 hr 4 min

1 hr 39 min

1 hr 23 min

1 hr

6 min

UltraFill User Manual

troubleSHootIng guIde

UltraFill Station

Problem Possible Cause Your Action

Power switch is on but no

LED’s are illuminated.

Device is not plugged in or there is a power failure.

Check the power outlet and verify that the device is plugged in.

Cylinder is connected

but no blue LED’s are

illuminated.

Cylinder is not fully connected.

Press cylinder disconnect button and remove cylinder. Verify there is no obstruction to cylinder

ll connection. Retry connecting cylinder with rm

downward force.

DO NOT LUBRICATE CYLINDER FITTING WITH

OIL OR GREASE. If the condition persists contact your home care provider.

Cylinder is connected,

at least one blue LED is

illuminated, but ll will not

start.

Cylinder is not fully connected. Internal part failure.

Press the cylinder disconnect button and remove the cylinder. Verify there is no obstruction to the cylinder

ll connection. Retry connecting the cylinder with rm downward force. DO NOT LUBRICATE THE CYLINDER FITTING

WITH OIL OR GREASE.

If the problem persists, contact your home care

provider.

Yellow LED is blinking

with or without periodic beep.

Incorrect oxygen pressure from the concentrator. Cylinder valve may be open (only applicable if the OCD/Regulator is not attached).

Verify that the oxygen concentrator and UltraFill are connected properly. Check for kinked or obstructed tubing. If the OCD/regulator is not attached to the

cylinder, verify that the cylinder valve is closed. If the problem persists, contact your home care

provider.

Yellow LED is illuminated. The UltraFill device has

detected low oxygen purity.

Press the start/stop button.

Check the ow meter on the concentrator and verify the ow is ≤ 3 LPM (5L concentrator) or ≤ 7 LPM (10L concentrator).

Wait 5 minutes and press the start/stop button.

If the problem persists, contact your home care

provider.

Problem Possible Cause Your Action

Yellow LED is illuminated,

Red LED is blinking and the audible alarm is sounding continuously.

Average O2 purity in the

cylinder is below 90%.

Press the stop button. Disconnect the cylinder from the device and empty it. Do not use the cylinder.

Check the ow meter on the concentrator and verify the ow is ≤ 3 LPM (5L concentrator) or ≤ 7 LPM (10L concentrator). Wait 5 minutes.

Attach a new cylinder and press the start button.

If the problem persists, contact your home care

provider.

Red LED is illuminated and the audible alarm is sounding continuously.

The device has detected a system malfunction.

Verify the cylinder is centered. If not, adjust it until it is

sitting correctly on the Cylinder Rest.

Otherwise, turn off the device and wait 5 minutes.

Restart the device.

If the problem persists, contact your home care

provider.

One blue LED is ashing

but the cylinder pressure is not increasing.

Internal part failure. Cylinder valve may be open. (Only applicable if the OCD/Regulator is not attached).

Press the cylinder disconnect button and remove the cylinder. Verify there is no obstruction to the cylinder

ll connection. DO NOT LUBRICATE THE CYLINDER FITTING

WITH OIL OR GREASE.

If the OCD/regulator is not attached to the cylinder,

check to make sure the cylinder valve is closed. Reconnect the cylinder. Press the start button.

If the problem persists, contact your home care

provider.

UltraFill User Manual

Cylinder with Conserving Device or Regulator

If your cylinder fails to operate properly, refer to the chart below for possible solutions. If your problem is not listed below, contact your home care provider. Do not attempt any maintenance procedures other than those listed below.

Problem Probable Cause

The cylinder won't pulse when I use it. Check to see if the cannula is adjusted properly around your nose

and has not slipped to one side.

Close your mouth and breathe only through your nose. If the

portable device still does not pulse, then try each of the following:

- Check for a pinched or broken cannula, which could interrupt airow.

- Make sure the connection between the cannula and cylinder is

secure.

- If you have moisture in the cannula, replace it with a dry one.

- Check to see if there is oxygen in the cylinder.

- Check that the conserving device is set to the number prescribed

by your physician.

If some other adjustment is necessary, contact your home care

provider.

There's no ow from my cylinder. Check the oxygen level gauge to see if the cylinder is empty. If so,

rell it.

Make sure the setting on the conserving device or regulator is set to

the number prescribed by your physician.

If these solutions do not solve the problem, contact your home care

provider.

The device pulses when I exhale. Check for a pinched or broken cannula which could interrupt ow.

If some other adjustment is necessary, contact your home care

provider.

My use times are different from those shown in this manual.

It is normal to have a small variation from the gures provided in

this manual. However, if your times are very different from those shown in this manual, there may be a leak. If you are in pulse dose,

you may be using a different conserving device with a different conserving ratio. Contact your home care provider.

cleanIng and maIntenance

Cleaning

Warning: Disconnect the power cord from the electrical outlet before cleaning the housing of the UltraFill Station.

Warning: Do not use any oil, grease, or petroleum-based products on or near this unit.

The outer housing of the UltraFill Station may be cleaned with a mild household detergent and a damp cloth or

sponge. Avoid using large quantities of water to clean the unit and do not use any petroleum-based solvents or

cleaning agents.

Wipe the device completely dry after you have nished cleaning it.

The Philips Respironics UltraFill Oxygen Cylinders should be kept clean and free from moisture and dust. Clean the

cylinders as needed by wiping with a dry, lint-free cloth. Do not clean with a solvent based cleaning solution. Avoid getting uids or debris such as sand or dirt inside the oxygen cylinder.

Maintenance

The UltraFill device requires no periodic maintenance during or in between patient use. There is a bacteria lter located inside the UltraFill, which can be changed at the provider’s discretion.

The UltraFill cylinders utilize an Aluminum alloy. They should undergo hydrostatic testing every 5 years. Cylinders that have not been tested for over 5 years should not be used.

The “Cylinder Specication” section of this manual outlines the use and storage environmental conditions. Care

should be taken to ensure this is followed.

tranSportIng tHe ultraFIll SyStem

Warning: to prevent an accidental tip over, do not attempt to move the UltraFill when it is connected to a cylinder.

During operation, the device is should be upright with the all four wheels contacting the oor.

Use the handles on either side of the UltraFill device to lift it (see illustration). The device can be transported in any orientation. Verify the protective cap is covering the oxygen cylinder connector before transport.

UltraFill User Manual

SpecIFIcatIonS

Environmental

Operating Transport and Storage

Temperature: 54° F to 90° F

(12° C to 32° C)

-4° F to 140° F (-20° C to 60° C)

Relative Humidity: 20 to 90% non-condensing 15 to 95% non-condensing

Physical

Height: 25.5 in (64.8 cm)

Weight: 45 lbs (20.4 kg)

Electrical

Nominal Voltage: 120 VAC 60 Hz

Power: 110 W

Amperes: 1.0 A at 120 V

Standards Compliance

This device is designed to conform to the following standards:

• IEC 60601-1, 2nd edition, Medical Electrical Equipment – Part 1: General Requirements for Safety (plus

national deviations)

• IEC 60601-1-2: 2001: Medical electrical equipment – Part 1-2: General requirements for safety- Collateral standard: Electromagnetic compatibility – Requirements and tests

IEC 60601-1 Classication

• Degree of Protection Against Electric Shock: Class II

• Type B Applied Part

• Protection against ingress of liquids: IPX1

• Continuous Operation

Cylinder Specications

Operating Transport & Storage

Temperature: 41° F to 104°F

(5° C to 40°C)

-4° F to 130°F (-20° C to 54°C)

Relative Humidity: 0% to 90%, non-condensing 0% to 90%, non-condensing

Cylinder Size Volume

(L)

Typical Fill Times

Empty Weight

Dimensions Operating Range Tank Pressure

2000 psi (135 bar)

200 to 2000 PSIG (14 to 138 bar)

M4 103 45 min 2.9 lb

(1.3 kg)

3.2"D x 12.75"L (81mm x 324mm)

M6 148 1 hr 5 min 3.2 lb

(1.4 kg)

3.2"D x 15.55"L (81mm x 395mm)

M9 246 1 hr 50 min 4.7 lb

(2.1 kg)

4.4"D x 14.35"L (112mm x 365mm)

MD15 413 3 hr 5 min 6 lb

(2.7 kg)

4.4"D x 19.95"L (112mm x 507mm)

ME24 679 5 hr 8.6 lb

(3.9 kg)

4.4"D x 28.95"L (112mm x 735mm)

3000 psi (200 bar)

200 to 3000 PSIG (14 to 207 bar)

MB08 232 1 hr 45 min 3.2 lb

(1.4 kg)

3.2"D x 15.55"L (81mm x 395mm)

MC13 354 2 hr 35 min 5 lb

(2.3 kg)

4.4"D x 14.35"L (112mm x 365mm)

MD22 604 4 hr 25 min 6.7 lb

(3 kg)

4.4"D x 20.05"L (112mm x 509mm)

ME36 992 7 hr 20 min 9. lb

(4.45 kg)

4.4"D x 29.05"L (112mm x 738mm)

Disposal

When it becomes necessary, dispose of the device in accordance with local regulations.

UltraFill User Manual

emc InFormatIon

guIdance and manuFacturer’S declaratIon – electromagnetIc emISSIonS: This device is

intended for use in the electromagnetic environment specied below. The user of this device should make sure it is used in such an

environment.

emISSIonS teSt complIance electromagnetIc envIronment – guIdance

RF emissions CISPR 11

Group 1 The device uses RF 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 CISPR 11

Class B The device is suitable for 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.

Harmonic emissions

IEC 61000-3-2

NA No test requirements for devices that operate at 115 VAC 60 Hz.

Voltage uctuations/Flicker emissions IEC 61000-3-3

guIdance and manuFacturer’S declaratIon – electromagnetIc ImmunIty: This device is intended for use in

the electromagnetic environment specied below. The user of this device should make sure it is used in such an environment.

ImmunIty teSt Iec 60601

teSt level

complIance level electromagnetIc envIronment

– guIdance

Electrostatic Discharge (ESD)

IEC 61000-4-2

±6 kV contact ±8 kV air

Floors should be wood, concrete or ceramic tile. If oors are covered with synthetic material, the relative humidity should be at least 30%.

Electrical Fast Transient/Burst

IEC 61000-4-4

±2 kV for power supply lines ±2 kV for power supply mains Mains power quality should be that of a typical

home or hospital environment.

Surge

IEC 61000-4-5

±1 kV Line to Line ±1 kV line to line Mains power quality should be that of a typical

home or hospital environment.

Voltage dips, short

interruptions and voltage variations on power supply input lines

IEC 61000-4-11

<5% U

(>95% dip in UT) for 0.5 cycle

40% U

(60% dip in UT) for 5 cycles 70% UT (30% dip in UT) for 25 cycles

<5% UT (>95% dip in UT) for 5 sec

<5% U

(>95% dip in UT) for 0.5 cycle

40% U

(60% dip in UT) for 5 cycles 70% UT (30% dip in UT) for 25 cycles

<5% UT (>95% dip in UT) for 5 sec

Mains power quality should be that of a typical

home or hospital environment. If the user of

the device requires continued operation during power mains interruptions, it is recommended

that the device be powered from an uninterruptible power supply.

Power frequency (60 Hz) magnetic eld IEC 61000-4-8

3 A/m 3 A/m Power frequency magnetic elds should be at

levels characteristic of a typical location in a typical hospital or home environment.

Note: UT is the a.c. mains voltage prior to application of the test level.

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Respironics UltraFill User Manual

Specifications and Main Features

Frequently Asked Questions

User Manual