Companion 5 Technical Manual
Contents
1. Interference may occur in the vicinity of equipment marked with the following symbol NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflec tion from structures objects and people Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the Companion 5 is used exceeds the applicable RF compliance level above the Companion 5 should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as re orienting or relocating the Companion 5 Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m DRAFT PN 14940837 B 9 Oxygen Concentrator Recommended separation distances between portable and mobile RF communications equipment and the Companion 5 The Companion 5 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the Companion 5 can help prevent electromagnetic interference by main2. 3 Bear concentrator Lassen Verify that the concentrator is in a well ventilated location and that air flow into the device Low Oxygen is not impeded Concentration below 87 ae Tubing Kinked Leak Check all internal tubing for leaks Verify that there are no leaks and that all connections are secure ee ee any tubing or parts if necessary concentration H TET Valve Malfunction Verify the operation of the 4 way solenoid valve Replace if necessary the operation of the 4 way solenoid valve Replace if necessary 6 Compressor Malfunction erify that the compressor is operating properly Replace if necessary Sieve Bed Failure the sieve beds assembly Verify that the concentrator is in a well ventilated location and that air flow into the device 1 Poor Concentrator Location is not impeded Verify that the cooling fan is connected properly to the circuit board and check the continu ity of the connection Replace the cooling fan if it is not functioning eg Tubing Kinked Leak Check all internal tubing for leaks Verify that there are no leaks and that all connections are Outlet Pressure secure Replace any tubing or parts if necessary Out of Accept 2 eae Out of Adjustment Adjust the regulator able Range 4 3 4 9 psi Regulator Malfunction Replace the regulator Sieve Bed Failure Replace the sieve beds assembly Overheating 2 Cooling Fan Malfunction DRAFT PN 14940837 B 26 Oxygen Concentrator
3. 4 Verify that the green LED turns on and stays lit continuously during operation Power Failure Alarm Test 1 Connect the electrical cord to a power source 2 Turn the power switch in the ON position and let the unit run for a few minutes 3 Keeping the switch in the ON I position disconnect the electrical cord from its outlet power 4 Verify that the audible alarm begins to sound continuously If the audible alarm does not sound refer to the Troubleshooting section of the manual for No Power Failure Audible Alarm 5 Turn the power switch in the OFF O position The alarm should stop 6 Plug the electrical cord back into an electrical outlet 7 Turn the power switch in the ON I position The green light should remain lit continuously Product Regulator Check and Setting The product regulator is factory set at 4 6 psig 31 7 kPa and should not require adjustment To check for proper adjustment of the product regulator take the following steps 1 Set the unit s I O power switch to the I position 2 Turn the flow meter adjustment knob counter clockwise until it reaches maximum flow 3 Allow the unit to run for ten minutes 4 Install test pressure gauge to the outlet of the Companion 5 unit 5 The outlet pressure should be 4 3 4 9 psig 29 6 33 8 kPa If the outlet pressure is not within this range the product regulator needs to be adjusted Adjusting
4. Audible Alarm The CAIRE Companion 5 contains an audible buzzer that is sur face mounted on the PCB Its purpose is to alert users of alarm conditions The microprocessor detects alarms by reading the input from the OCSI sensor and the mains power switch When there is an alarm condition the microprocessor sends a signal to activate the audible alarm LED Lights There are two 2 or three 3 OCSI LED lights that are surface mounted on the PCB They are visible from the front of the concentrator and their purpose is to alert the user of operating conditions or alarms The top LED indicator is green It remains on at all times when the power switch is in the ON I position and the electrical cord is plugged in A continuous green light indicates normal operation The next LED indicator will be red This light will indicate mal functions with the device When the microprocessor detects an alarm condition from the power switch or the flow rate sensor it will send a signal for the red LED to illuminate The red LED will indicate a system malfunction loss of power or flow rate is out of specifications The bottom LED indicator will be yellow OCSI Models only This light will only indicate low oxygen concentration This LED will illuminate when the microprocessor detects an alarm condition from the OCSI sensor The LED will be solid if the oxygen concen tration is 70 85 and it will flash if the concentration is less than
5. Power frequency Power frequency magnetic fields should be 50 60 Hz mag at levels characteristic of a typical location netic field IEC in a typical commercial or hospital environ 61000 4 8 ment NOTE U is the a c mains voltage prior to application of the test level DRAFT PN 14940837 B 8 Oxygen Concentrator Guidance and manufacturer s declaration electromagnetic immunity The Companion 5 is intended for use in the electromagnetic environment specified below The customer or the user of the Companion 5 should assure that it is used in such an environment Immunity test IEC 60601 test level Compliance level Electromagnetic environment guidance Portable and mobile RF communications equipment should be used no closer to any part of the Companion 5 including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance Conducted RF 3 Vas d 1 2VP IEC 61000 4 6 150 kHz to 80 MHz d 12FP 80 MHz to 800 MHz Radiated RF 3 V m d 23VP 800 MHz to 2 5 GHz IEC 61000 4 3 80 MHz to 2 5 GHz where P is the maximum output power rat ing of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in metres m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range
6. 70 The warning alarms section will describe these alarm conditions in detail and provide basic troubleshooting steps PN 14940837 B 13 Oxygen Concentrator OCSI Sensor OCSI units only The OCSI sensor detects the oxygen concentration of the air being delivered to the patient The sensor consists of an intake and outlet port on each end of a flow path that is encased in an air tight cover The microprocessor determines concentration from the OCSI sensor output and activates alarms when appropriate The limits for alarm conditions are programmed into the software of the microprocessor and are described in the Warning Alarms section of this manual 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 means that the alarms associated with the OCSI will not activate until this predetermined amount of time has passed DRAFT Serial Number Identification The serial number of the CAIRE Companion 5 is located on the back label of the outer case The serial number is in the middle of the label just below the bar code A sample label is shown below ro ET 3204 SN CBB69XXXXXXXX Refi15067005 pg EA cine CBB69XXXXXXXX Fsoeen Figure 7 Serial Number Label End of Life At the end of the service life of the CAIRE Companion 5 it should be disposed of in accordance wit
7. Flow Meter Bottle Support Stand Bottle optional BACK Air Inlet Exhaust Vent DRAFT PN 14940837 B 4 Oxygen Concentrator Companion 5 Oxygen Concentrator Specifications Dimensions H x W X D 21 5 x 12 5 x 13 5 inches 54 6cm x 31 8cm x 34 3cm Weight Companion 5 Flow Settings Continuous Flow measured in Liters Per Minute LPM 36 0 pounds 0 5 to 5 0 LPM Continuous Flow Accuracy Oxygen Concentration 10 or 200ml min whichever is greater 90 5 5 3 for all flow settings Oxygen Output Pressure 4 6 psig 31 7 kPa nominal LED Status Indicators Green Light Normal Operation Red Indicates flow rate error loss of power ambient pressure reading out of range or general system malfunction Yellow Light Poor Oxygen Concentration below 85 OCSI models only Nominal Sound Level 2 0 LPM Continuous Flow 40 dB A Operating Environment Temperature Humidity 41 F to 104 F 5 to 40 C 10 to 95 Non condensing 82 4 F 28 C Maximum Dew point Storage Environment Temperature Humidity Altitude Operating Range 40 F to 158 F 40 to 70 C Up to 95 Non condensing 1253 to 9878 ft 382 to 3010 m Nominal Power 350 Watts Maximum 250 watts at 2 0 LPM F Ratin 230VAC unit T4AL 250V ed 120VAC unit TBAL 250V Continuous Flow Indication Expressed in liters per minute LPM Audible Alarm Indicators See ALARM CONDITIO
8. Symptom Possible Cause Corrective Action Constant 1 Power tailure Verify that the electrical cord is plugged into an outlet and that there is power being sup Audible Buzzer plied to the outlet Replace the electrical cord if necessary With Red Light Alarm Code 2 Blown Fuse Replace fuse on circuit board AL P02 Verify that the electrical cord is plugged into an outlet and that there is power being sup No Power Being Supplied plied to the outlet Also check the household circuit breaker Will Not Turn Verif itch j i in Gireui y that the power switch is plugged into to the main circuit board Replace the power On When Power Power Switch Malfunction switch if necessary Switch is ON z 7 Er p O 3 Electrical Cord Malfunction Verify that the electrical cord is plugged into to the main circuit board Replace the electrical cord if necessary Replace fuse on circuit board Verify that the electrical cord is plugged into an outlet and that there is power being sup No Power Being Supplied plied to the outlet LED Lights Will P svar f PENT Net illuminate a Circuit Boardivialiunetion nea all connections to the circuit board are intact Replace the main circuit board if 3 Blown Fuse Fuse Replace fuse on circuit board Audible Alarm Verify that all connections to the circuit board are intact Replace the main circuit board if Circuit Board Malfunction Does Not Sound necessary DRAFT PN 14940837 B 2
9. Use the following checklist as a guide to assist in setup and training a patient on the use of the Companion 5 and its accessories Patient Name Companion 5 Serial Training Topic Pre Delivery Check List Indications for Use Contraindications Basic Concept Training Advise to read the Users Manual Safety Guidelines and Operational Safety Warnings Cautions Locating the Companion 5 Indicators Alerts and Alarms Companion 5 Maintenance Clean and Care for the Cannula per manufacturer s instructions Clean the Cabinet as needed Schedule PM every 2 years Trained By DRAFT PN 14940837 B 19 Oxygen Concentrator Biannual Maintenance Provider Introduction Properly maintaining the Companion 5 will ensure longer life and higher performance Minimum biannual maintenance is required CAUTION The Companion 5 contains electrostatic sensitive components Do not open or handle except at a static free workstation Do not remove cover with out electrostatic discharge ESD protection Maintenance Check List Perform the following maintenance procedures at least every two years or more often as needed The frequency of the periodic maintenance should be based on the environment in which the Companion 5 is used e Inspect AC Power cord and plug for damage e Read and record hour meter e Check flow rate concentration and alarm functions e Replace air intake filter and bacteria filter Maintenance Schedule Bi
10. a specific oxygen flow rate setting to meet patients individual needs Recommended oxygen flow rates should be adjusted only under the advice of a physician WARNING Federal law restricts this device to sell by or on the order of a physician Contraindications WARNING The Companion 5 is not intended for life sup AN porting or life sustaining applications nor does it provide any patient monitoring capabilities WARNING In certain circumstances the use of non prescribed AD oxygen can be hazardous This device should only be used when prescribed by a physician WARNING Not for use in the presence of flammable anes As with any electrically powered device the user may experience periods of non operation as a result of electrical power interruption or the need to have the Companion 5 serviced by a qualified technician A The Companion 5 is not appropriate for any patient who would experience adverse health consequences as a result of such temporary inter ruption DRAFT Introduction Welcome to the CAIRE Companion 5 oxygen concentrator 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 this section While setting up and training a patient be sure to point out the advantages of the Companion 5 For example e Easy to use controls e Quiet operation e Se
11. and settings of the concentrator The microprocessor is directly respon sible for the following functions of the concentrator e Cycling timing of the 4 way solenoid valve e Driving the LCD display e Controlling the audible alarm e Controlling the operational and warning LED lights e Reading input from the OCSI sensor OCSI models only The microprocessor is programmed with the alarm thresholds and trigger points as well as the timing of the 4 way solenoid valve to cycle between sieve beds A diagram of the input and output of the microprocessor is shown below in Figure 5 Each input and output is described further in the following sections 02 Concentration Signal Connection to PC Figure 5 Microprocessor Operation Block Diagram DRAFT 4 Way Solenoid Valve The solenoid valve is connected to the circuit board s microproces sor by a 4 pin connector The microprocessor is responsible for sending the signal to open and close the valves This cycles the air through alternating sieve beds for the PSA process The timing for alternating the sieve beds is programmed into the microprocessor LCD Display The 6 digit digital LCD display is mounted on the PCB and is vis ible on the front of the concentrator Its purpose is to continually count and display the hours that the 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
12. e The Companion 5 contains electrostatic sensi tive components Do not open or handle except at a static free workstation Do not AN remove cover without ESD protection e Avoid possible eye injury by wearing protec tive eye wear or shielding the eyes from pos sible flying debris DRAFT 1 Lay the unit on its side and use a long stem Phillips to remove the 6 screws from the back case VTE ie 2 Separate the front case from the back case 3 Using a flat head screwdriver loosen the clamps holding the braided tubing to the 4 way solenoid 4 Disconnect the braided tubing from the 4 way solenoid PN 14940837 B 30 Companion53 Ve 5 Cut zip tie from the tubing attached to the regulator and 8 The two cases should now separate completely for service to remove this tube the internal components e Sieve bed is now exposed Recommend plugging or capping the valve to avoid sieve bed moisture contamination Outlet Pressure Test Turn the power switch to the ON position 2 Set the flow meter to 5 LPM 3 Allow the concentrator to run for a minimum of ten 10 minutes 4 Connect an external test pressure gauge to the outlet barb 5 Verify that the flow meter ball drops to a reading of 0 LPM 6 Observe the reading on the pressure gauge Acceptable read 6 Disconnect both the 4 way solenoid and power cord electri ings should range between 4 3 4 9 psig cal wires from the main circuit
13. other equipment and that if adjacent or stacked use is necessary the Companion 5 should be observed to verify normal operation in the configuration in which it will be used Guidance and Manufacturer s Declaration electromagnetic emissions The Companion 5 is intended for use in the electromagnetic environment specified below The customer or the user of the Companion 5 should assure that it is used in such an environment Emissions Test Compliance Electromagnetic environment guidance The Companion 5 uses RF energy only for its internal function Therefore RF emissions Em i Group 1 its RF emissions are very low and are not likely to cause any interference in EN 55011 nearby electronic equipment RF emissions Class B EN 55011 Harmonic emissions IEC 61000 3 2 The Companion 5 is suitable for use in all establishments including domestic Class A establishments and those directly connected to the public low voltage Voltage fluctuations flicker emissions IEC 61000 3 3 power supply network that supplies buildings used for domestic purposes Complies DRAFT PN 14940837 B 7 Oxygen Concentrator Guidance and manufacturer s declaration electromagnetic immunity The Companion 5 is intended for use in the electromagnetic environment specified below The customer or the user of the Companion 5 should assure that it is used in such an environment Immunity test IEC 60601 test level Co
14. previous proce dure 4 Disconnect the clear tubing from the regulator 5 Turn the regulator counter clockwise to disconnect it from the sieve bed base Figure 17 Showing Connections to Pressure Regulator 6 To replace reverse steps 1 5 DRAFT Check Valve 1 Press the power switch in the OFF position and unplug the electrical cord 2 Remove the outer case 3 Disconnect the clear tubing from each side of the flapper valve that will be replaced 4 Remove the flapper valve from the concentrator 5 To replace reverse steps 1 4 PN 14940837 B 34 Oxygen Concentrator Compressor 1 Press the power switch in the OFF position and unplug the electrical cord 2 Remove the outer case Sieve bed is now exposed Recommend that the tubing be capped to limit exposure of sieve bed to moisture Do not touch capacitor wire contacts because of risk of electrical shock 4 Pull upward to remove capacitor 5 Remove the four 4 screws from the compressor cover using a Phillips screwdriver DRAFT sor 7 Lift the compressor from the bottom of the case to remove it from the concentrator 8 To replace reverse steps 1 7 PN 14940837 B 35 Oxygen Concentrator Printed Circuit Board PCB 1 Press the power switch in the OFF position and unplug the electrical cord 2 Remove the outer case 3 Disconnect all wires from the PCB noting location of wires conne
15. that can be experienced by the CAIRE Companion 5 Alarm Audible Colored Possible Cause Your Action Code Alarm LED None Off Green Solid The Companion 5 is None working properly AL PO1 Continuous Red Solid System Malfunction Turn the power switch in the OFF position immediately Disconnect the AC Power from the wall outlet Wait 5 minutes Connect the AC Power back into the wall outlet and turn the concentrator back on again If the alarm continues service is required Connect to a backup oxygen supply and contact your healthcare provider immediately AL PO2 Continuous Red Solid The concentrator Verify that the concentrator s electrical cord is plugged into an outlet has lost power but and that the outlet has power Try a different outlet If the problem the power switch is continues connect to a back up oxygen supply and contact your still in the ON I healthcare provider position AL P20 Beeping Red Low Product Flow 1 Ensure that the cannula is not kinked or blocked If used with a Flashing Rate humidifier bottle ensure that it is filled properly and not creating a AL P40 Beeping Red High Product Flow blockage ae Flashing Rate 2 Ensure that the Companion 5 has proper ventilation Make sure there are at least 12 inches between the back and sides of the Companion and any obstructions furniture curtain etc 3 If the problem persists switch to an alternate source of oxygen and contact healthcare provid
16. the Product Regulator for Normal Operation 1 Disconnect the humidifier bottle if used and the tubing from oxygen outlet 2 Remove the outer case 3 Connect the electrical cord to a power source 4 Set the unit s I 0 power switch to the I position and allow DRAFT unit to run at least ten minutes to build up pressure 5 Turn the flow meter adjustment knob counter clockwise until it reaches maximum flow 6 Install pressure gauge to the outlet of the Companion 5 7 Turn the adjustment screw using a 3 32 Allen wrench until the outlet pressure is 4 6 psig 31 7 kPa 8 Remove the test pressure gauge and replace the outer case 9 Perform flow rate test to ensure flow rates are still within specifications 4 Way Solenoid Valve 1 Press the power switch in the OFF position and unplug the electrical cord 2 Remove the outer case 3 Disconnect the solenoid s wires from the PCB 4 Remove the 4 screws that mount the solenoid assembly to the sieve bed using a 5 32 Allen wrench 5 Pull outward to remove the 4 way solenoid assembly 6 Remove clamp on silicone hose PN 14940837 B 33 Oxygen Concentrator 7 Remove silicone hose from 4 way solenoid valve 8 To replace reverse steps 1 7 Pressure Regulator Replacement 1 Press the power switch in the OFF position and unplug the electrical cord 2 Remove the outer case 3 Remove the 4 way solenoid valve per the
17. the cabinet and power supplies To disinfect the Companion 5 use Lysol Brand II disinfectant or equivalent Proceed as directed by the manufacturer Disconnect and remove ALL power supply con nectors before cleaning the exterior cabinet DO NOT use denatured alcohol or apply liquid spray or aerosol cleaners Shipping and Transporting the Companion 5 When shipping the Companion 5 use original packaging if pos sible If original packaging material is not available then place the Companion 5 in a plastic bag and surround the concentrator with a minimum of two inches of soft foam packing material or bubble wrap Place the Companion 5 in an appropriate cardboard box for shipping DO NOT expose the Companion 5 to water Electrical shock or damage to the unit may result Storing the Companion 5 Heat and humidity may degrade performance or severely damage the Companion 5 Store the device in a cool dry protected area away from high temperatures moisture and humidity Discarding Local environmental laws may prohibit disposal of electrical and or electronic equipment such as the Companion 5 Contact the local city or town offices for instructions on proper disposal of electrical or electronic equipment Alternately CAIRE Inc may be contacted for disposal information PN 14940837 B 23 Oxygen Concentrator Provider Service and Maintenance Record Whenever maintenance or service is performed on an Compan
18. the electrical operation of the o concentrator Contains a programmable micropro Circuit Board h A es PCB cessor that controls valve timing alarm indications and OCSI functions if applicable Table 2 Internal Components of Concentrator DRAFT Pressure Swing Adsorption The CAIRE Companion 5 utilizes the Pressure Swing Adsorption PSA Process to concentrate oxygen gas from ambient air In the PSA process a compressor draws ambient air into the machine through an intake filter The compressor then forces the filtered air into a solenoid valve which directs the air into one of two tanks that are full of a molecular sieve material referred to as sieve beds As the pressure in sieve bed 1 increases nitrogen molecules are removed from the ambient air and are stored in the sieve material The gas that exits sieve bed 1 is highly concentrated oxygen The majority of this gas flows through an orifice to sieve bed 2 and is used to purge the stored nitrogen gas from its sieve material The remainder of the oxygen gas is directed through a flapper valve to the product holding tank Here it is stored for delivery to the patient Sieve bed 1 continues to pressurize until the sieve material is completely saturated with nitrogen At this time the printed circuit board PCB switches the state of the solenoid valve dumping pressurized air in sieve bed 1 back into the atmosphere via the purge muffler Simultaneously the valve now direc
19. 7 Oxygen Concentrator Alarm Conditions and Alarm Codes Use the table below to decode Companion 5 alarm conditions If other alarm codes are displayed by the Companion 5 contact Chart Technical Support for assistance The following table is intended as a guide for the provider not the user Warning Alarms The CAIRE Companion 5 contains both visual and audible alarms to alert the user when there is a malfunction with the unit The audible buzzer and the LED lights work in conjunction to display operating and alarm conditions of the concentrator The audible buzzer has the ability to both pulse beep and to sound continu ously 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 power switch is in the ON I position 2 Red LED Indicates flow rate error loss of power ambient pressure reading out of range or general system malfunc tion The concentrator requires service if this light is on with the exception of flow rate alarm 3 Yellow LED Indicates poor oxygen concentration below 85 flashing or 70 solid See the following table for more information The concentrator requires service if this light is on Figure 6 LED Display Non OCSI left OCSI right DRAFT PN 14940837 B 28 Oxygen Concentrator The table below shows all of the alarm conditions
20. II CAIRE A Chart Industries Company AirSep SeQual Companion 5 Oxygen Concentrator PROVIDER TECHNICAL MANUAL DRAFT Table of Contents General Information nennnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnunnnnnnnn 3 Warning and Caution Statements rrmaeravvrrrrrrrvrrrnrrrrrnn 3 Introduction to the Companion 5 Oxygen Concentrator 4 Companion 5 Oxygen Concentrator Specifications 5 Provider Support Policy rrrrnvrnnnnnvnnnnnvnnnnnvnnnnnvnennnnnnnnnnnnnnnnr 6 Electromagnetic Compatibility rrrnvrnnnnvrnnnnvvnnnnvnnnnnnvnnnnnenr 7 Guidance and Manufacturer s Declaration electromagnetic EIMISSIONS E I EE T E E 7 Guidance and manufacturer s declaration electromagnetic Ten SEE ERE EET 8 Guidance and manufacturer s declaration electromagnetic IMMUN Se eset nei en iiaeie dete eee ts 9 Recommended separation distances between portable and mobile RF communications equip ment and the Companion S rrrnrnrnvnrnrrnnrnrrrrnrernnnnnnn 10 Theory of Operation rrnnnrnnnnnnvnnnvnnnnvnnnnvnnnennnnnnnnnnnnnnnnnnn 11 INNO G UCHOM RE EE EE 11 Pressure Swing Adsorption marrrrrrrrrrrrrvrrnrrrnnrrrrnnnrnnnnnr 11 POW DEE scvetes teu deaneealocantmustindtoses nasen 12 Electrical Operation rnorororrrvvrnrrsrrnrrrvnnnrnnnnnnrnnnrrnnnnr 12 MICroprotessoP ivatjerarkaent hdeskidgened anden 13 4 Way Solenoid Valve rrrnnrnnnnrnronrnrnrnnrnrrrnnnrrnnnnrnrnnernnn 13 ECD DIE 0 EE 13 Au
21. N AND ALARM CODES Back Up Alarm Power HEPA Compressor Intake Filter Device Classification IEC Class II Type BF Applied Part IPX1 To ensure there is no power to the Companion 5 oxygen concentrator please unplug cord DRAFT PN 14940837 B 5 Oxygen Concentrator Independent Safety Testing IEC 60601 1 1988 A1 1991 A2 1995 Corrigendum 6 95 sateiy EN 60601 1 1990 A1 1993 A2 1995 A12 1993 A13 1996 Corrigenda 7 94 FCC 15B Sec 107 amp 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 Electromagnetic Compatibility The CAIRE Companion 5 is designed to comply with the following standards e EN 60601 1 2 Electromagnetic Compatibility e IEC 60601 1 General Requirement for Basic Safety of Electrical Medical Equipment e ISO 8359 Oxygen Concentrators For Medical Use e ISO 13485 Medical Device Quality System e 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 whi
22. ace reverse steps 1 5 DRAFT PN 14940837 B 38 Oxygen Concentrator Parts Price List Contact Customer Service or visit www cairemedical com to obtain your parts list DRAFT PN 14940837 B 39 Oxygen Concentrator Optional Accessories Visit us at www CAIREmedical com for more information about optional accessories There are many different types of oxygen tubing cannula and humidifiers The following items are recom mended by CAIRE Inc for use with the Companion 5 Salter Labs Humidifier Part Number HU003 1 or equiva lent If your physician has prescribed an optional humidifier fol low the manufacturer s instructions for use Attach the humidifier to the oxygen outlet port of the Companion 5 Use of optional humidifiers not recommended for the Companion 5 may impair performance of the device and may void the warranty CAIRE Humidifier Adapter Part Number 3509 SEQ If your physician has prescribed an optional humidifier you may need to use the CAIRE Humidifier Adapter Follow the instructions for use Attach the Humidifier Adapter to the oxygen outlet port of the Companion 5 and then to the humidifier Attach the cannula or oxygen tubing to the humidifier outlet Salter Labs Oxygen Supply Tubing Part Number Series 2000 or equivalent The internal diameter should be no less than 3 16 0 48 cm Connect the oxygen tubing to the outlet port of the humidifier or directly to the oxygen outlet port
23. annual Maintenance Check list Perform the following maintenance procedures at least once every two years or more often as needed The frequency of the periodic maintenance should be based on the environment in which the Companion 5 is used e Replace air inlet filter e Replace bacteria filter Oxygen Concentration Check CAIRE recommends the oxygen concentration be checked peri odically as required by the provider For non OCSI units CAIRE recommends a 6 month interval between concentration checks DRAFT PN 14940837 B 20 Oxygen Concentrator Ma i ntena nce Proced ures 4 Disconnect the HEPA filter from the outlet barb tubing 5 Disconnect the HEPA filter from flow meter tubing The following section lists procedures that are necessary to maintain the Companion 5 Service should only be performed by a qualified technician To perform periodic maintenance the only tools that should be necessary are e 1 Phillips screwdriver e Wire cutting pliers e Small cable ties e ESD Mat or approved ESD system e Flat head screwdriver Disconnect all power supplies going to the unit prior to performing the following steps HEPA Filter 1 Press the power switch in the OFF position and unplug the electrical cord 2 Lay the unit on its side and use a long stem Phillips to remove the 6 screws from the back case Figure 15 Bacteria Filter 6 Remove the filter 7 To replace reverse steps 1 7 e Dir
24. board If the outlet pressure reading is not between 4 3 4 9 psig refer to the Troubleshooting section of this manual and the steps for Poor Outlet Pressure 7 Turn the power switch in the OFF position 8 Remove the pressure gauge from the outlet barb 7 Cut zip tie securing all wires together DRAFT PN 14940837 B 31 Oxygen Concentrator Flow Rate Test 1 Turn the power switch in the ON position 2 Allow the concentrator to run continuously for a minimum of 10 minutes 3 Connect a flow meter to the outlet barb 4 Turn the flow knob to the position of 0 5 LPM 5 Verify that the flow displayed by the flow meter is within the tolerances shown in table below 6 Flow Rate must be 10 or 200ml min whichever is greater See table below Table 8 Flow Rate Tolerances LPM Flow LPM Flow LPM 10 080 120 O 7 Repeat steps 4 and 5 with each incremental flow setting If any flow rates are out of tolerance refer to the Troubleshooting section of this manual and the steps for Low or Fluctuating Flow Rates DRAFT PN 14940837 B 32 Oxygen Concentrator Start up Verification Test 1 Connect the electrical cord to a power supply 2 Turn the power switch in the ON position 3 Initially all LED lights will illuminate and the audible alarm will beep After a few seconds the yellow and red LED lights should turn off and the audible alarm will stop
25. centrator and their functions Reference Table 2 and Figure 3 on the following page for clarification while reading the Theory of Operation Section of the manual Item Function Provides HEPA level filtration for intake to compres Intake Filter sor c Pump that routes air into and through the concen ompressor trator Cooling Fan Cools the compressor area 4 Way Routes air flow through one sieve bed and vents the purged air to the atmosphere from the other Solenoid bed Responsible for alternating flow between the Valve beds Sieve Beds Chemically adsorbs nitrogen molecules from the 2 air Orifice Routes a larger portion of air exiting one sieve bed back through the other bed for purging Routes a smaller portion of air exiting one sieve Flapper Valve bed into the product holding tank Prevents back flow from product tank to sieve bed Product Holds concentrated oxygen prior to its regulation Holding Tank and delivery to the patient Pressure Reduces the outlet pressure to be compatible with Regulator the flow meter and accessories Detects oxygen concentration of flow exiting the OCSI Sensor concentrator OCSI models only Sends a signal to activate alarm if concentration is too low Flaw Conttol Integral needle valve that controls volumetric flow Valve LPM to the patient Is read against the printed scale HEPA Filter HEPA level filtration of outlet flow Printed Responsible for all of
26. ch 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 DRAFT PN 14940837 B 6 Oxygen Concentrator Electromagnetic Compatibility Medical Electrical Equipment needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in this manual Portable and mobile RF communications equipment can affect Medical Electrical Equipment The use of Accessories transducers and cables other than those specified with the exception of transducers and cables sold by the Manufacturer of this device as replacement parts for internal components may result in increased Emissions or decreased Immunity of the Companion 5 The Companion 5 should not be used adjacent to or stacked with
27. cted to PCB Figure 18 Diagram Showing all PCB connections amp Mounting 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 DRAFT PN 14940837 B 36 Sieve Bed Assembly Cooling Fan 1 Press the power switch in the OFF position and unplug the electrical cord It is recommended to always replace sieve beds in pairs to ensure the both beds are in optimum working condition 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 Do not open the sieve beds or handle the molecu lar sieve 1 Press the power switch in the OFF position and unplug the electrical cord 2 Remove the outer case 3 Unscrew the purge muffler by turning it counter clockwise to remove it Loosen with a wrench if needed 5 Pull outward to slide the compressor cover out from the body of the concentrator 6 Slide the cooling fan out of the fan shelf 4 Pull outward on the top of the sieve bed assembly to remove it from the grommet at the top of the case 5 Lift upward to remove the sieve beds and product holding chamber from the base of the concentrator 7 To replace reverse steps 1 6 6 To replace reverse steps 1 5 DRAFT PN 14940837 B 37 Oxygen Concentrato
28. cting the AC Power Plug the electrical cord of the CAIRE Companion 5 into an AC outlet WARNING INSPECT THE ELECTRICAL CORD FOR DAMAGE BE To ensure that there is no power to the Companion 5 unplug from AC power FORE USE IF THE CORD IS DAMAGED DO NOT PLUG IT INTO AN Note Turn the Companion 5 to the Off 0 position to avoid alarming before ELECTRICAL OUTLET OR ATTEMPT TO OPERATE THE CONCENTRA disconnecting the AC Power cord TOR Using Around the House Your patient may use 50 tubing when operating the Companion 5 in the house When a humidifier is used the tubing between it and the patient must not exceed 7 CAUTION When using a humidifier adapter of any kind the Companion 5 unit must remain stationary meaning that the unit must NOT be moved or Press the power switch in the ON I position transported in any manner to avoid damage to the Companion 5 Locating the Companion 5 for Proper Use and Ventilation Ask your patient where they would like to set up the device Whenever possible the Companion 5 should be in the same room as the patient for convenience and assurance that the patient can adequately hear and respond to Companion 5 alerts and alarms While unpacking and setting up the device tell your patient about these important cautions and warnings When the Companion 5 is plugged in properly and turned on a green indicator on the LED Display will light up After initiall
29. d Turn the flow control knob to 5LPM Connect a calibrated oxygen analyzer to the outlet barb Verify that this display reads between 87 95 5 W D OL e If the oxygen concentration is not between 87 95 5 refer to the troubleshooting sec tion of this manual for Low Oxygen Con centration e If the concentrator is alarming and the oxygen concentration measured is greater than 85 replace the main PCB Figure 11 Filter Cover 4 Pull outward to remove filter cover Figure 11 Filter Cover DRAFT PN 14940837 B 22 Oxygen Concentrator Record Hours of Operation To help maintain the Companion 5 you may obtain the total hours of operation Hour Meter A digital hour meter is mounted on the PCB and is displayed on the concentrator s front panel Its purpose is to continually count and display the hours that the concentrator has been in operation The hour meter cannot be re set and displays time to the nearest tenth of an hour DRAFT Cleaning the Companion 5 Clean inside the unit as needed using a small vacuum cleaner or brush to remove any accumulation of dust or debris prior to at taching the covers Use mild detergent solution to clean the cabinet Turn OFF the Companion 5 and disconnect from AC power before any clean ing or disinfection activity DO NOT spray the cabinet Use a damp not soaking wet cloth or sponge Spray the cloth or sponge with a mild detergent solution to clean
30. dible Alarm en 13 LED BYA Sgrena 13 OCSI Sensor OCSI units Only ssie 14 Serial Number Identification ervvrrrrrvrrnervrrnrrorrnrrnnne 14 End OATS see 14 User Controls And System Status Indicators 000 15 Indications for USC ssrrarnvrnrnnvvrnnnnvennnnernnnnvnnnnnvnesnnvensnnnnernn 16 ContraindicatiOns errnnnnvvnnrnnnnvevnvnnnnnvennvnnnnnennernvnnnenerrnnnner 16 Introduction ircen 16 Pre Delivery Check LiStisceicisseraienis seines 16 Using Around the House erreren 17 Locating the Companion 5 for Proper Use and Ventilation17 Power On and Warm UD sinnerman 17 Adjust Flow Control Rate corensis 18 Maintenance Patient rrrnnvvnnrnnnnnvvnnrnnnnnvvnnrnnnnnvnnennnnnnvnnnr 19 Clean and Care for Tubing and CMM es Ledet ikt 19 Clean the C binet anuarmuvenimadar min guvieiteniaes 19 Patient Training Checklist senretene 19 DRAFT Biannual Maintenance Provider rnnnnnnnnnvvvrnnnnnnnnnnnnnnnnn 20 Iftrodueton sss aeaaaee NE EEEE AARRE 20 Maintenance Check Listini 20 Maintenance Schedule avrrnnnnnnnnnnnnnnnnnnnnnnnnnnnnnennnnnnnnnnn 20 Biannual Maintenance Check list rrrrrrrrrrrrrrrrrrsvrrrnnnr 20 Oxygen Concentration Check rrnrrnrrvrrnrrrrnnrrrrrrrrrrnnnennn 20 Maintenance Procedures vvrrnnnnnnrnnnsnnnnnnnnnnnnnnnnnnennnnnnnnnnn 21 Oxygen Concentration Test nnmnssnnravrrrrrrnnrrrnrnrrrrnnnennn 22 Record Hours of Operation assrrsrrrrvrrrrrnrrrr
31. e unwanted contaminants are removed The oxygen is then delivered to the patient through the outlet barb Figure 3 Schematic Diagram of Pneumatic Operation DRAFT Electrical Operation All electrical components of the CAIRE Companion 5 are all con trolled by a PCB The electrical cord supplies mains AC power 120 VAC 60 Hz North American or 230 VAC 50 Hz European to the main circuit board when the power switch is in the ON I position The PCB distributes the mains power to all of the electri cal components The AC mains power is distributed and routed di rectly to the compressor and the cooling fan The compressor and cooling fan both operate at 120 VAC 60 Hz North American or 230 VAC 50 Hz European The remaining power travels to a DC power convertor regulator Figure 4 is a block diagram show ing the flow and distribution of mains power into the concentra tor AC to DC Converter To Microprocessor ls Cooling Fan Compressor 120 VAC 960 Hz N America 120 VAC LAG America ce AE OE 230 VAC 50 Hz Europe 230 VAC 50 Hz Europe sowats 500 Watts Figure 4 Diagram of Mains Electrical Distribution PN 14940837 B 12 Oxygen Concentrator Microprocessor The microprocessor is the only processing element of the CAIRE Companion 5 It contains embedded software which is pro grammed with all of the parameters for alarm conditions
32. ection of flow on the filter is indicated by the text IN Bacteria filter is flow direc tional e In the picture above IN should be facing down or opposite of the flow control valve MT i DO NOT use any petroleum based or other lubri T cants A spontaneous and violent ignition may occur if oil grease or other petroleum substances come into contact with oxygen under pressure Keep these substances away from the oxygen con centrator tubing and connections and any other oxygen source IHI 3 Separate the front case from the back case DRAFT PN 14940837 B 21 Oxygen Concentrator Always cut the heads of cable ties to avoid damag 5 Pull outward on the intake filter to remove from its compart Note ment ing the tubing 6 To replace reverse steps 1 5 Intake Filter 1 Press the power switch in the OFF position and unplug the Oxygen Concentration Test electrical cord CAIRE recommends testing the oxygen concentration at least once 2 Lay the concentrator gently on its side to access the bottom every six months for non OCSI units of the unit 3 Remove screw with Phillips Screw Driver from the filter cover See picture below 1 Plug the AC Power Cord into an electrical outlet and turn the power switch in the ON I position 2 Allow the concentrator to run continuously for a minimum of 10 minutes Disconnect the tubing and or cannula from the outlet barb if one is attache
33. er for assistance AL P04 Beeping Yellow Failed O2 Alarm 1 Ensure the air intake filter is not is not clogged or restricted Clean Flashing Condition 02 and replace the filter if necessary Levels Less Than 2 Ensure the Companion 5 is in a well ventilated area Make sure 70 there are at least 12 inches between the back and sides of the AL PO8 Continuous Yellow Solid Poor 02 Alarm Companion 5 and any obstructions furniture curtain etc Condition 02 3 If the condition persists switch to an alternate source of oxygen Levels Between and contact your healthcare provider immediately 70 and 85 Note The alarm codes will be additive if more than one code is active For example if the unit is undergoing a high product flow rate alarm and a poor 02 alarm condition the alarm code will be P40 P08 P48 The concentrator will continue normal operation even though an alarm condition is in effect The power failure alarm will have the ability to sound for a period after power has been disrupted to the device The audible alarm is powered by a super capacitor that is charged by the PCB while the concentrator is in operation It takes the audible alarm approxi mately 30 minutes to fully charge The capacitor has a set of contacts that is activated when the power switch is in the ON position and no AC power is being supplied The alarm is stopped by re supplying power to the concentrator All other alarms will continue until the alar
34. function Verify that the compressor is operating properly Replace the compressor if necessary 1 Oxygen Tubing Kinked Leak Check the nasal cannula and any extension tubing being used for kinks blockages or leaks ing Verify that all tubing connections are secure Replace any tubing if necessary feed Bottie Restriction Check the humidifier bottle and tubing for blockages or restrictions Verify that the concentrator is in a well ventilated location and that air flow into the device 3 Poor Concentrator Location i is not impeded Low Qr Fluctuat Intake Filter Restriction Inspect the intake filter for a blockage Replace if found to be clogged ed Flow Bacteria Filter Restriction Inspect the Bacteria filter for a blockage Replace if found to be clogged a Tubing Kinked Leak Check all internal tubing for leaks Verify that there are no leaks and that all connections are i secure Replace any tubing or parts if necessary 7 m Meter Malfunction Verify the functionality and accuracy of the flow meter Replace if necessary g Regulator Malfunction elas the outlet pressure If it is out of the acceptable range adjust or replace the regula 9 Compressor Malfunction Fer that the compressor is operating properly Replace if necessary 1 Intake Filter Restriction Inspect the intake filter for a blockage Replace if found to be clogged Bacteria Filter Restriction Inspect the Bacteria filter for a blockage Replace if found to be clogged
35. h local regulations PN 14940837 B 14 Oxygen Concentrator User Controls And System Status Indicators Definition Read user manual before operation See user manual for instructions No Smoking Icon Do not smoke near unit Warnings ALERT Yellow Indicator Class II equipment Oxygen Output Type BF Applied Part degree of protection against electric shock This symbol is to remind the equipment owners to return it to a recycling facility at the end of its life per Waste Electrical and Electronic Equipment WEEE Directive Authorized representative in the European Community Definition Certified for both the U S and Canadian markets to the applicable U S and Canadian standards This device complies with the requirements of Directive 93 42 EEC concerning medical devices It therefore bears the CE marking as shown Drip Proof Equipment IPX1 The Companion 5 provides protection against the harmful effects of the ingress of liquids IPX1 per IEC 60529 Name and address of manufacturer Buzzer An audible alarm or buzzer is used to alert you to the operating condition of the device either a warning or failure DRAFT PN 14940837 B 15 Oxygen Concentrator Indications for Use The Companion 5 is indicated for the administration of supple mental oxygen The device is not intended for life support nor does it provide any patient monitoring capabilities A physician must prescribe
36. hould drop to the bottom of the flowmeter If the ball does not drop completely to the bottom there is a leak present between the top of the flowmeter and the outlet of the unit If concentrator is not meeting specifications make sure that the unit is leak free by testing all tubing connections and fit tings with leak testing solution Protect circuit board s from solution and start leak test at the compressor following air flow to oxygen outlet Repair all leaks by tightening connec tions and fittings If unit is alarming refer to the Alarm Indicator Chart for probable solutions DRAFT PN 14940837 B 25 Oxygen Concentrator Troubleshooting Table oe Tubing Kinked Leak Check the nasal cannula and any extension tubing being used for kinks blockages or leaks Verify that all tubing connections are secure Replace and tubing if necessary B um pe Check the humidifier bottle and tubing for blockages or restrictions 3 Flow Meter Closed off Inspect the flow meter and verify that the ball is not at the bottom of the meter If it is turn No Oxygen Flow the knob to increase the flow Replace the flow meter if necessary ride Tubing Kinked Leak Check all internal tubing for leaks Verify that there are no leaks and that all connections are secure Replace any tubing or parts if necessary 5 Bacteria Filter Restriction Inspect the bacteria filter for a blockage Replace if found to be clogged 6 Compressor Mal
37. ion 5 unit an entry should be made in the service log for that concen trator 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 Procedures in this manual Companion 5 Serial Number Hour meter Dale Reading Initials Service Performed System Checkout Concentration Flow Alarms Comments DRAFT PN 14940837 B 24 Oxygen Concentrator Troubleshooting Service and Repair Procedures CAUTION The Companion 5 contains electrostatic sensitive components Do not open or handle except at a static free workstation Do not remove cover with out ESD protection General Troubleshooting Before reviewing the troubleshooting chart the following steps may be useful to isolate any malfunctions UT Turn on the concentrator If the unit does not turn on refer to the troubleshooting chart Allow the unit to warm up for approximately 10 minutes and check oxygen concentration Perform the flow rate test Verify flows are within acceptable range per Table 8 Make sure the unit is cycling properly by observing the flow meter ball is stable flow meter ball does not move up and down more than liter Place your thumb over outlet of unit The flowmeter ball s
38. lf monitoring alarm system After completing each training procedure ask your patient if he or she has any questions Proper training of your patients will result in fewer service calls improved compliance and increased patient satisfaction Pre Delivery Check List Verify that the Companion 5 is provided to the patient with the following items Users Manual Cannula Power Insert the AC power cord into an electrical outlet to check for proper operation Before delivering the device check and log the status of the fol lowing using the LCD Display Hours on the hour meter Software Revision The LCD Display will show this upon startup You may adjust the liter flow settings to your patient s prescription when you deliver and set up the device Connecting the AC Power The Companion 5 operates from external power 1 Plug the power cord into an AC outlet 2 The Companion 5 is now ready for use If the Companion 5 is not receiving power when it is turned on the unit will alarm and display a solid red light Ensure adequate clearance around the AC Cord PN 14940837 B 16 Oxygen Concentrator CAUTION e DO NOT connect the Companion 5 to an Note After completing this training procedure ask your patient if he she has extension cord or electrical outlet controlled any questions by a switch A e Always check to see that the Air Inlet and the Exhaust Vent are not blocked Power On and Warm Up Disconne
39. m condition has been corrected Service to the concentrator by authorized personnel is rec ommended anytime an alarm condition is experienced Procedures for servicing and testing the unit are outlined in the Troubleshoot ing section of this manual DRAFT PN 14940837 B 29 Oxygen Concentrator Repair and Testing Procedures The following test and repair procedures have been developed to allow for both performance verification of the CAIRE Companion 5 as well as proper removal and replacement of defective parts If a unit fails any given test refer to the Troubleshooting section of the manual Please carefully read and understand the following safety adviso ries before performing repair procedures e Verify that the power switch is in the OFF position and the electrical cord is unplugged before performing any repairs unless other wise noted e Make sure your hands are free of oils and greases CAUTION o l Do not allow liquid leak detector to come in con tact with electrical parts e All replacement parts must be factory ap proved They should be marked Cleaned for Oxygen Service and should be stored in sealed plastic bags e Use only replacement parts authorized by CAIRE Inc e Service of the CAIRE Companion 5 should be performed by authorized personnel only Outer Case e Keep hands out of moving parts e Disconnect power before removing the unit cover e ESD Safety procedure must be in place
40. mpliance level Electromagnetic environment guid ance Electromagnetic 6 kV contact 6 kV contact Floors should be wood concrete or ceramic environment tile If floors are covered with synthetic guidance material the relative humidity should be at 8 kV air 8 kV air least 30 IEC 61000 4 2 Electrical fast tran 2 kV for power supply 2 kV for power supply Mains power quality should be that of a sient burst lines lines typical commercial or hospital environment IEC 61000 4 4 1 kV for input output N A lines Surge 1 kV line s to line s 1 kV line s to line s Mains power quality should be that of a typical commercial or hospital environment IEC 61000 4 5 2 kV line s to earth 2 kV line s to earth Voltage dips short lt 5 U lt 5 U Mains power quality should be that of a interruptions and gt 95 dip in U gt 95 dip in U typical commercial or hospital environment voltage variations j If the user of the Companion 5 requires on power supply for 0 5 cycle for 0 5 cycle continued operation during power mains input lines IEC interruptions it is recommended that the 61000 4 11 40 U 40 U Companion 5 be powered from an uninter ruptible power supply or a battery 60 dip in U 60 dip in U for 5 cycles for 5 cycles 70 U 70 U 30 dip in U 30 dip in U for 25 cycles for 25 cycles lt 5 U lt 5 U gt 95 dip in U gt 95 dip in U for 5 sec for 5 sec
41. nrrnrrrnnrnnen 23 Hour Meter neneiia a Aei 23 Cleaning the Companion 5 rrrrsvvnrrvvrnrrerrnrrsnnnrrrrnnnrrnnn 23 Shipping and Transporting the E E A E AA AE E 23 Storing the Companion 5 rrrnnrrrvrvrrnnrrnrrrrrnrrrvrrrrnrrrrrrnnn 23 DIScarding sauna a a ees 23 Provider Service and Maintenance Record 0006 24 Troubleshooting Service and Repair Procedures 25 Troubleshooting Table nmerrrrrrrrrrravvrnrnersrrvrnnnrrrrrrnnnennr 26 Alarm Conditions and Alarm Codes rxanrrranannnnnnnnnnnnener 28 Warning AlafMmS uuaettanaserudanvaastennedeeedain 28 Outer CaS iiccecciecdadestecsansnacesksaphleistddandin sks EEEa E E 30 Outlet Pressure TeSt sonnenneu 31 Flow Ratt WS ti eisena pa ao Aa 32 Start up Verification Test smmrsrnervrrrvrrrrrrrrrnrrrnnrrnnrn nn 33 Power Failure Alarm Test rrrrrrrrrrrvrrrrrrrrrnnrrrrrsrsrrrrnrnnnn 33 Product Regulator Check and Setting 0 ccceeseeeees 33 Adjusting the Product Regulator for Normal Operation rsrrrrrvrrrrrvvvrernn 33 Pressure Regulator Replacement rnrrvnnnnrnnvnrrrrnnnrnnnnnr 33 Flapper Check Valve Lim muermmmmmmmmmm 34 COMPIESSON sunarsee antasbansirdneteeopdd dnne E elegant 34 Printed Circuit Board PCB ursssnvvvrrrrrrrrrrrrerrrrrrrrrvvreenr 35 A Way Solenoid Valve rsrnnnnnrrnrnanrnrrrrrrrrrrnnnnrnnnnnrrnnnnnnn 35 Sieve Bed Assembly snuron aa 36 COOLING Faiga aeoea ienn e Aea 36 Power S
42. nue its products or change the prices ma terials equipment quality descriptions specifications and or processes to its products at any time without prior notice and with no further obligation or consequence All rights not expressly stated herein are reserved by us as applicable DRAFT PN 14940837 B 41
43. of the Com panion 5 if you do not use a humidifier Connect the other end of the tube to the nasal cannula if oxygen supply tubing is not already attached to the cannula Tubing not specified for use with this Companion 5 may impair the performance of the device Salter Labs Oxygen Cannula Part Number 1600 Series or equivalent Your physician will have prescribed a cannula to deliver oxygen In most cases they are already attached to the oxygen tubing If not follow the instructions included with the cannula to attach it to the oxygen tubing Use of an oxygen can nula not specified for use with this Companion 5 may impair the performance of the device DRAFT PN 14940837 B 40 Oxygen Concentrator CAIRE Inc Customer Service Contact Information If you need any additional assistance contact CAIRE Inc tal By mail CAIRE Inc 2200 Airport Industrial Drive Suite 500 Ball Ground GA 30107 USA By telephone 800 482 2473 By E mail techservice usa chart ind com www CAIREmedical com Authorized European Union Representative Medical Product Services GmbH Borngasse 20 35619 Braunfels Germany E mail techservice europeQchart ind com www CAIREmedical com Companion 50 are registered trademarks of CAIRE Inc PRO2 Check Elite is a trademark of Salter Labs Inc Lysol is a registered trademark of Reckitt Benckiser UK CE 0029 Copyright 2014 Chart Industries CAIRE Inc reserves the right to disconti
44. r Power Switch Power Cord 1 Press the power switch in the OFF position and unplug the 1 Press the power switch in the OFF position and unplug the electrical cord electrical cord 2 Remove the outer case 2 Remove the outer case 3 Disconnect the wires from the back of the power switch 3 Disconnect the electrical cord s wires from the PCB 4 Push the switch out through the front of the case 4 Release the 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 Leak Testing 1 Press the power switch in the OFF position and unplug the electrical cord 2 Remove the outer case 3 Apply a stream of liquid leak detector Snoop or a mild so lution of soap and water all fittings and tubing connections Excessive bubbling indicates a leak 4 Replace any tubing that leaks or that appears cracked and worn 5 Replace the outer case 5 To replace reverse steps 1 5 Flow Meter 1 Press the power switch in the OFF position and unplug the electrical cord 2 Remove the outer case 3 Remove the two 2 clear tubes that are connected to the flow meter barbs These barbs are surrounded by the PCB 4 Loosen the nuts from the threaded fitting on the back of the flow meter using pliers 5 Pull outward on the flow meter from the outside of the con centrator to remove it 6 To repl
45. s ae es mile To adjust flow rate Turn counter clockwise to increase flow Turn clockwise to decrease flow The middle of the ball indicates flow rate There are two sets of lines front and back In the example below the flow meter would read 4LPM 5 4 3 Correct SCRIBED LEVEL OF OXYGEN DO NOT CHANGE THE FLOW WARNING IT IS VERY IMPORTANT TO SELECT ONLY THE PRE SELECTION UNLESS YOU HAVE BEEN DIRECTED TO DO SO BYA LICENSED CLINICIAN THE OXYGEN CONCENTRATOR MAY BE USED DUR ING SLEEP UNDER THE RECOMMENDATION OF A QUALIFIED CLINICIAN DRAFT PN 14940837 B 18 Oxygen Concentrator Maintenance Patient Clean and Care for Tubing and Cannula Provide your patient instructions on cleaning disinfection and or replacement information for the tubing and cannula Clean the Cabinet To clean the cabinet do the following 1 Turn OFF the Companion 5 and disconnect from AC power before any cleaning or disinfection activity 2 Use mild detergent and water solution 3 Use a damp not soaking wet cloth or sponge 4 Spray or wet the cloth or sponge with the mild detergent solution DO NOT spray the cabinet 5 Wipe down the cabinet 6 To disinfect the Companion 5 use Lysol Brand II disinfec tant or equivalent Spray or wet a cloth or sponge with the disinfectant DO NOT spray the cabinet or the LED LCD display Proceed as directed by the manufacturer Patient Training Checklist
46. taining a minimum distance between portable and mobile RF communications equipment transmitters and the Companion 5 as recommended below according to the maximum output power of the communications equipment Rated maximum Separation distance according to frequency of transmitter output power of m transmitter 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz d 1 2 P d 1 2 JP d 23 VP For transmitters rated at a maximum output power not listed above the recommended separation distance d in metres m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer NOTE 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people DRAFT PN 14940837 B 10 Oxygen Concentrator Theory of Operation Introduction The Companion 5 is a stationary medical device used to extract oxygen from the atmosphere concentrate it to 87 95 5 and present the oxygen to the patient The device will operate in Continuous Flow Mode In Continuous Flow Mode the oxygen is provided at a constant flow rate between 0 5 and 5 0 LPM Con tinuously Variable Table 2 below lists the major internal components of the con
47. ts the com pressed air into sieve bed 2 which has been completely purged of nitrogen gas and is ready for nitrogen adsorption oxygen concen tration This cycle continuously repeats pressurizing and depressur izing the sieve beds feeding concentrated oxygen to the product holding tank PN 14940837 B 11 Oxygen Concentrator Flow Delivery Oxygen exiting the product holding tank flows through a pressure regulator that reduces the high pressure oxygen to a lower more manageable pressure before it is delivered to the patient This ensures that the oxygen flowing from the device will work ap propriately with accessories and provide a safe pressure for patient delivery The Companion 5 oxygen concentrator may be equipped with an Oxygen Concentration Status Indicator OCSI In that case oxygen gas exiting the pressure regulator flows through a check valve and then through the OCSI sensor This is the same area of the concentrator where the flow is measured The PCB monitors the concentration and the flow measured by these sensors and it will activate a warning light and audible alarm if the concentra tion drops below predetermined levels described in the Warning Alarms section of the manual After exiting the concentration and flow rate sensors oxygen flows through the flow control valve FCV at the LPM flow rate selected by the patient and indicated on the flow meter The oxygen gas then flows through the bacteria filter wher
48. witch rrnrrrrrrrrrnrnrnrrrrrrrsvarvvrrrrrrersnnsrrrrrssrrrrnnnnnn 37 Fom Mee 37 POWEr C rdiuaasasegsmsinnaehendsleshavassedankansiede 37 teak TESNO prises senenn ian e E aaa 37 P rts Price LiStiscs fcecceiscss vendidededestdselceewestetersunstectleteveeessegens 38 Optional ACCOSSOMAS esaii aaa aka 39 CAIRE Inc Customer Service Contact Information 40 Oxygen Concentrator General Information This technical manual will familiarize you with Provider specific information regarding the Companion 5 oxygen concentrator Instructions in this manual are intended to help ensure that e Providers are familiar with Companion 5 system components and system principles of operation e Providers are given proper guidance in the use of the Com panion 5 and its accessories that can be conveyed to patients e Providers are made aware of the care diagnostics mainte nance and repair of the Companion 5 Warning and Caution Statements Safety instructions are defined as follows Important safety information for hazards that might cause serious injury CAUTION l l l Important information for preventing damage to the Companion 5 Places emphasis on an operating characteristic or important consideration DRAFT PN 14940837 B 3 Oxygen Concentrator Introduction to the Companion 5 Oxygen Concentrator Companion 5 FRONT Power Switch Outer Case Oxygen Outlet Barb LED Display LCD Display Humidifier
49. y powering ON the device please allow up to ten 10 minutes for the device to reach its performance specifications Note All LED lights will illuminate upon start up After the concentrator com pletes the warm up cycle only the green light will remain on WARNING LOCATE THE COMPANION 5 IN A WELL VENTILATED SPACE THAT PROVIDES ADEQUATE AIRFLOW WARNING ENSURE THAT FURNITURE DRAPERIES OR CLOTHING For OCSI Models The 02 Light will illuminate for four 4 seconds WILL NOT IMPEDE AIR CIRCULATION upon start up After this initial start up this light is disabled for WARNING AVOID PLACING THE UNIT OVER A FLOOR HEAT REGISTER OR PPFOximately ten 10 minutes while the concentration rises to AGAINST A BASEBOARD HEATING SYSTEM specifications WARNING DO NOT USE IN THE PRESENCE OF FLAMMABLE ANESTHETICS SOLVENTS AEROSOLS OR FLAMMABLE CLEANING AGENTS WARNING AVOID HIGH POLLUTANT ENVIRONMENTS CAUTION Some patients are highly mobile and may use the device under varying circumstances Make The warm up period could be up to 10 minutes After this time only the green LED remains lit to indicate normal operation T sure your patient or patient caregiver completely understands the basic precautions to safely locate the device DRAFT PN 14940837 B 17 Oxygen Concentrator Adjust Flow Control Rate Turn the flow control knob to the oxygen flow rate LPM prescribed by your physician eee _ bk e
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