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Oxygen Concentrator

 6

Independent Safety Testing

Safety

IEC 60601-1 :1988 + A1 :1991 + A2 :1995 + Corrigendum (6/95) 

EN 60601-1(1990) + A1(1993) + A2(1995) + A12(1993) + A13(1996) + Corrigenda (7/94) 

Electromagnetic 

Compatibility

FCC 15B (Sec. 107 & 109), EN55011, EN60601-1-2 :2001, EN61000-3-2, 

EN61000-3-3, IEC61000-4-2, IEC61000-4-3, IEC61000-4-4, IEC61000-4-5, 

IEC61000-4-6, IEC61000-4-8,  IEC61000-4-11, IEC 60601-1-2 :2001

The CAIRE Companion 5 is designed to comply with the following standards:

EN 60601-1-2—Electromagnetic Compatibility

IEC 60601-1—General Requirement for Basic Safety of Electrical Medical Equipment

ISO 8359—Oxygen Concentrators For Medical Use

ISO 13485—Medical Device Quality System

UL 60601-1 – General Requirement for Basic Safety of Electrical Medical Equipment

It is classified as Class 2 Medical Device by the United States Food and Drug Administration (FDA) and as a Class IIA device by
the European Medical Device Directive (MDD).

Provider Support Policy

Objective

:  As a manufacturer our organizational goal is to provide customer support and assistance to the highest level of excellence

.

Customers

 are Providers (which include Dealers, Distributors and Agents). 

Support

 includes, but is not limited to, troubleshooting and Return Material Authorizations (RMA). 

Business Hours

 are Monday – Friday, 8:30am – 5:00pm EST.  

CAIRE Inc. can only support customers who are recognized as Providers, Dealers, Distributors and/or Agents. 
These partnerships are qualified as having an existing account or are in the process of credit application completion. All patient or 

end-user inquiries including but not limited to RMA, warranty or serial number questions must be handled by their Provider.  

Provider Support Policy:

  CAIRE Inc. is unable to provide direct assistance, clinical advice or recommendations to a patient or 

end-user. Providers have sole responsibility in assisting their patients. 

Summary of Contents for Companion 5

Page 1: ...PROVIDER TECHNICAL MANUAL Companion 5 Oxygen Concentrator...

Page 2: ...Patient Training Checklist 18 Preventive Maintenance Provider 19 Introduction 19 Maintenance Check List 19 Table of Contents Maintenance Schedule 19 Handle Gross Particle Filter Optional 19 Bottom Gr...

Page 3: ...tic or important consideration Symbol Definition Symbol Definition Read user manual before operation See user manual for instructions I O On Off Switch No Smoking Icon Do not smoke near unit Use no oi...

Page 4: ...e Companion 5 Oxygen Concentrator FRONT Companion 5 LED Display Power Switch Flow Meter Oxygen Outlet Barb Humidi er Bottle Support Stand Bottle optional LCD Display Outer Case BACK Exhaust Vent Cooli...

Page 5: ...gen Concentration below 85 Nominal Sound Level 2 0 LPM Continuous Flow 50 dB A Operating Environment Temperature Humidity 41 F to 104 F 5 to 40 C 15 to 90 Non condensing 82 4 F 28 C Maximum Dew point...

Page 6: ...ug Administration FDA and as a Class IIA device by the European Medical Device Directive MDD Provider Support Policy Objective As a manufacturer our organizational goal is to provide customer support...

Page 7: ...served to verify normal operation in the con guration in which it will be used Guidance and Manufacturer s Declaration electromagnetic emissions The Companion 5 is intended for use in the electromagne...

Page 8: ...s 2 kV line s to earth 1 kV line s to line s 2 kV line s to earth Mains power quality should be that of a typical commercial or hospital environment Voltage dips short interruptions and voltage varia...

Page 9: ...s determined by an electromagnetic site survey a should be less than the compliance level in each frequency range b Interference may occur in the vicinity of equipment marked with the following symbol...

Page 10: ...tter W Separation distance according to frequency of transmitter m 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 1 2 2 3 10 3 8 3 8 7 3 100 12 12...

Page 11: ...ltration of outlet ow Printed Circuit Board PCB Responsible for all of the electrical operation of the concentrator Contains a programmable microprocessor that controls valve timing alarm indications...

Page 12: ...l After exiting the concentration and ow rate sensors oxygen ows through the ow control valve FCV at the LPM ow rate selected by the patient and indicated on the ow meter The oxygen gas then ows throu...

Page 13: ...he concentrator has been in operation and to display alarm conditions The LCD display cannot be re set and displays time to the nearest tenth of an hour Audible Alarm The CAIRE Companion 5 contains an...

Page 14: ...al The concentrator takes several minutes to build internal pressure and concentration This is known as the warm up period and the signal from the sensor is ignored by the PCB for ten 10 minutes This...

Page 15: ...Setting up and training your patient to use the Companion 5 has never been easier You can expect your patients and care providers to easily learn how to use the device by following the directions in...

Page 16: ...D SPACE THAT PROVIDES ADEQUATE AIRFLOW WARNING ENSURE THAT FURNITURE DRAPERIES OR CLOTHING WILL NOT IMPEDE AIR CIRCULATION WARNING AVOID PLACING THE UNIT OVER A FLOOR HEAT REGISTER OR AGAINST A BASEBO...

Page 17: ...tional Handle Gross Particle Filter if installed The patient should clean the handle gross particle lter weekly if installed Replace lter as needed 1 Remove dirty lter from inside unit handle 2 Wash d...

Page 18: ...e with the disinfectant DO NOT spray the cabinet or the LED LCD display Proceed as directed by the manufacturer Patient Training Checklist Use the following checklist as a guide to assist in setup and...

Page 19: ...Harsh environments may require air intake lter replacement more frequently than every 2 years Internal HEPA Disc Filter The internal HEPA Filter does not have a requirement for replacement It is desi...

Page 20: ...Phillips Screw Driver from the filter cover See picture below Filter Cover 5 Pull outward to remove filter cover Filter Cover 6 Pull outward on the intake filter to remove from its compartment 7 To r...

Page 21: ...d by manufacturer of cleaning the product but do not spray liquid directly on Companion 5 WARNING Turn off the Companion 5 and disconnect from AC power DO NOT use denatured alcohol or apply liquid spr...

Page 22: ...rator or recorded in accordance with your company s standard procedure Whenever the case of the Companion 5 is opened the flow rate concentration and alarm status should be verified per the Test Proce...

Page 23: ...Table 8 4 Make sure the unit is cycling properly by observing the ow meter ball is stable ow meter ball does not move up and down more than liter 5 Place your thumb over outlet of unit The owmeter ba...

Page 24: ...fy that there are no leaks and that all connections are secure Replace any tubing or parts if necessary 7 Flow Meter Malfunction Verify the functionality and accuracy of the ow meter Replace if necess...

Page 25: ...itch is plugged into to the main circuit board Replace the power switch if necessary 3 Electrical Cord Malfunction Verify that the electrical cord is plugged into to the main circuit board Replace the...

Page 26: ...rm intermittently There are 3 LED warning lights that are visible on the front of the Companion 5 1 Green LED Indicates normal operation Illuminates when power is supplied to the concentrator and the...

Page 27: ...well ventilated area Make sure there are at least 12 inches between the back and sides of the Companion 5 and any obstructions furniture curtain etc 3 If the condition persists switch to an alternate...

Page 28: ...display screen will change to the number of hours and the O2 warning light will turn off 5 Verify that the green LED turns on and stays lit continuously during operation Power Failure Alarm Test 1 Con...

Page 29: ...5 contains electrostatic sensitive components Do not open or handle except at a static free workstation Do not remove cover without ESD protection Avoid possible eye injury by wearing protec tive eye...

Page 30: ...tances away from the oxygen concentrator tubing and connections and any other oxygen source Note Always cut the heads of cable ties to avoid damaging the tubing Outlet Pressure Test 1 Open up the unit...

Page 31: ...to the I position and allow unit to run at least ten minutes to build up pressure 5 Turn the ow meter adjustment knob counter clockwise until it reaches 5 LPM 6 Install pressure gauge as directed in t...

Page 32: ...t check for leaks using Snoop Make sure to use a torque driver that is set to 20 in lbs Compressor 1 Press the power switch in the OFF position and unplug the electrical cord 2 Remove the outer case N...

Page 33: ...2 Remove the outer case 3 Disconnect the cooling fan s wires from the PCB 4 Remove the 4 screws from the compressor cover using a Phil lips head screwdriver 5 Pull outward to slide the compressor cove...

Page 34: ...Screws 4 Remove the four 4 mounting screws on the PCB using a Phillips head screwdriver 5 Pull the PCB outward to remove it from the concentrator 6 To replace reverse steps 1 5 Sieve Bed Assembly WARN...

Page 35: ...oduct chamber while holding camber from the base of the concentrator 4 Unplug valve and power cord wire connections from PCB 5 Remove power cord by removing the cable tie or pulling the power cord thr...

Page 36: ...he strain relief surrounding the power cord on the back cabinet using strain relief pliers 5 Pull the power cord out of the concentrator 6 To replace reverse steps 1 5 assuring the power cord is route...

Page 37: ...meter should be no less than 3 16 0 48 cm Connect the oxygen tubing to the outlet port of the humidi er or directly to the oxygen outlet port of the Com panion 5 if you do not use a humidi er Connect...

Page 38: ...s Germany E mail TechService global caireinc com www caireinc com Companion 5 are registered trademarks of CAIRE Inc PRO2 Check Elite is a trademark of Salter Labs Inc Lysol is a registered trademark...

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