background image

Immunity Test 

IEC60601 test level 

Compliance 

Electromagnetic 

Environment-Guidance 

 

 

 

 

 

 

 

 

 

Conducted RF 

IEC 61000-4-6 

 

 

Radiated RF 

IEC 61000-4-3 

 

 

 

 

 

 

 

 

 

3Vrms150 kHz to 80 

MHz outside ISM 

bands

 

3 V/m    80 MHz to 

2.5 GHz 

 

 

 

 

 

 

 

 

 

 

 

3Vrms 

 

 

 

3V/m 

Portable and mobile RF 

communications equipment should 

be used no closer to any part of this 

device, including cables, than there 

commended separation distance 

calculated from the equation 

applicable to the frequency of the 

transmitter.  

 

Recommended separation distance 

 

P

d

2

.

1

=

 150kHz to 80MHz 

 

 

 

P

d

2

.

1

=

 150kHz to 80MHz 

P

d

3

.

2

=

80 MHz to 2.5G MHz 

 

Where P is the maximum output 

power rating of the transmitter in 

watts (W) according to the transmitter 

manufacturer and d is the 

recommended separation distance in 

meters (m).

b

 

 

Field strengths from fixed RF 

transmitters, as determined by an 

electromagnetic site survey

 c

, should 

be less than the compliance level in 

each frequency range

d

 

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 

reflection from structures, objects and people. 

a The ISM (industrial, scientific and medical) bands  between 150  kHz and 80 MHz are 6,765 MHz to  6,795 

MHz;13,553 MHz to 13,567 MHz; 26,957 MHz to 27,283 MHz; and 40,66 MHz to 40,70 MHz. 

b The compliance levels in the ISM frequency bands  between 150 kHz and  80 MHz and in the frequency range 80 

MHz to 2,5 GHz are intended to decrease the likelihood that mobile/portable communications equipment could cause 

interference if it is inadvertently brought into patient areas. For this reason, an additional factor of 10/3 is used in 

calculating the recommended separation distance for transmitters in these frequency ranges. 

c 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 

 

21 

Summary of Contents for Celestia 18250

Page 1: ...Celestia CPAP with Heated Humidifier Instruction Manual Model No 18250 Please read the instruction manual before use ...

Page 2: ...uards 1 1 Introduction 3 2 Product Description 4 3 Installation 6 4 Operation 9 5 Cleaning Maintenance 13 6 Troubleshooting 15 7 Technical Specification 17 8 Note Caution and Warning Statements 18 APPENDIX A EMC Information 20 ...

Page 3: ...han 35 C 95 F to prevent the airflow temperature from exceeding 40 C 104 F and causing irritation to your airway 5 If this device overheats it will stop operating and show Error Message 002 on the display After cooling down to proper temperature the device can restart again 6 This machine should be used only with masks and connectors recommended by the manufacturer or by your physician or respirat...

Page 4: ...the product to a service center for examination and repair 5 Keep the cord away from heated surfaces 6 Never block the air openings of this product or place it on a soft surface such as a bed or couch where their openings may be blocked Keep the air opening free of lint hair and other similar particles 7 Never drop or insert any object into any opening or hose 8 Follow the national requirement to ...

Page 5: ...004 These limits are designed to provide reasonable protection against harmful interference in a typical medical installation This equipment generates uses and can radiate radio frequency energy and if not installed and used in accordance with the instructions may cause harmful interference to other devices in the vicinity However there is no guarantee that interference will not occur in a particu...

Page 6: ...0 k cleared mask for CPAP 6 Carrying bag optional 7 USB cable and Easy Compliance CD Optional Note 1 ONLY for Physician or Technician to download data Patient should not use this function Note 2 Only applicable for devices with USB port CAUTION Patient should not connect the device to the personal computer for data downloading This may cause the CPAP system failure Air Filter USB Connector Power S...

Page 7: ... knob graduated from 1 to 6 is used to adjust the heating temperature of the heater plate from 30 C to 60 C Power On Indicator Green LED When lit this indicates the humidifier is turned on and ready for operation Heater On Indicator Yellow LED When lit this indicates the heater is turned on Inlet Port with Silicon Connector Connect to the outlet port of the CPAP device Outlet port Connect the flex...

Page 8: ...ng Up 1 Place the device on a flat surface and at a lower level than your sleeping position 2 Connect the power cord to the device and plug into main electrical outlet Turn on the device by pressing the ON OFF switch on the left side of the device Once the device is turned on it is in ready to operate position STANDBY sign appears in LCD display NOTE The plug is also served to disconnect the devic...

Page 9: ...350 ml 6 Slide the chamber into place Make sure the silicon connector on the inlet connector fit securely over the CPAP device air outlet Note Make sure the water chamber is pushed to the end to press against the heater plate switch At the same time the heater on indicator will be lit to indicate the heater plate starts to warm Note The heater will be automatically turned off while the water chamb...

Page 10: ...al mask over 40 C 104 F WARNING This device SHOULD NOT be used in the vicinity of a flammable anesthetic mixture in combination with oxygen or air and nitrous oxide WARNING Recommended operating atmospheric condition is above sea level up to 8000 feet if goes higher than 8000 feet re calibration is then required CAUTION At low pressures some exhaled gas may remain in the mask and be re breathed CA...

Page 11: ... Press the MENU button to enter the setting mode when device is in standby mode The adjustment setting includes ramp time selection ramp starting pressure altitude compensation therapy pressure adjustment alarm ON OFF clock alarm setting compliance meter and total operating meter When each setting s value has been changed press MENU for confirmation and press MENU again for next setting selection ...

Page 12: ...lect is 9 cmH2O 3 Therapy Pressure Press MENU button to select P XX XcmH2O menu you can view the current pressure setting displayed in cmH2O unit Therapy pressure is adjustable only by the provider a respiratory therapist or physician NOTE The therapy pressure is to only be prescribed by a physician 4 Altitude Compensation Press MENU button to select Alt XXX menu press UP or DOWN button to set the...

Page 13: ... display will show the time on the left side Press UP or DOWN button to set the time to wake you up Once the clock alarm is activated press the start standby button to mute the audible alarm 9 Clock Press MENU button to select Clock XX XX menu press UP or DOWN button to set the current time 10 Turn off the Device Turn off the device by pressing the ON OFF switch on the left side of the device NOTE...

Page 14: ... to enter next selection NOTE For physicians please refer to a separated Physician s Additional Instruction page Menu Ramp Ramp Time P Therapy Pressure Alt Altitude Compensation TM Total Meter Down Up Confirm 0 5 10 15 45 min 4 4 5 5 5 5 18 cmH2O 1 2 3 XXXX X hr Menu Ramp P Ramp Starting Pressure 3 3 5 4 4 5 17 cmH2O CM Compliance Meter XXXX X hr Alarm on off Clock Alarm on off Clock hh mm 12 ...

Page 15: ...water chamber Users must fill water no more than the marking for maximum volume after the water chamber is removed from the device 5 Cleaning Maintenance 5 1 Device The device should be checked and dusted regularly at least every 30 days Wipe with a damp cloth and a mild detergent and keep it free from dust If other detergent is used choose one that will have no chemical effects on the surface of ...

Page 16: ...agrance or conditioners as they will leave a residue WARNING The mask must not be re used by another person This is to avoid the risk of cross infection 5 3 Air Filter The air filter should be checked and replaced every 30 days or more often if this device is operated in a dusty environment 1 Remove the dirty filter from the enclosure on the front of the device 2 Insert a new filter 5 4 Water Cham...

Page 17: ...on indicator not light 1 Power cord not plug into a working AC outlet 2 Power switch is not turned on 3 PCB or indicator worn out 4 Fuse blown out 1 Plug in the power cord to a working AC outlet 2 See Setup procedure and turn the power on 3 Contact your local agent or EU representative for service 4 Contact your local agent or EU representative for service Heater on indicator not light at all 1 He...

Page 18: ...movable base plate is right fit into water chamber and fill the water till it reach fill line and check if it still leak or not 2 Replace a new water chamber Error Warning Messages show in LCD Message type Definition Message in LCD Error for abnormal system settings Error Primary function can t execute Error for flow generator failure Out of system memory Warning System memory is nearly full NOTE ...

Page 19: ...eater Settings 1 to 6 from 30 C 60 C Pressure Drop 0 2cmH2O 60LPM Humidity Output 10 40mgH2O L Temperature Operating 5 C to 35 C 41 F to 95 F Storage 15 to 50 5 F to 122 F Shipping 15 to 70 5 F to 158 F Environment Humidity Operating 15 RH to 95 RH non condensing Storage 10 RH to 90 RH non condensing Shipping 10 RH to 90 RH non condensing Air Tubing Flexible plastic 1 8m approx EN 60601 1 EN 60601...

Page 20: ...information about the recycling of this product please contact your local city office household waste disposal service or the retail store where you purchased this product Fill line Air flow direction 8 NOTE CAUTION AND WARNING STATEMENTS NOTE Indicate information that you should pay special attention to CAUTION Indicate correct operating or maintenance procedures in order to prevent damage to or ...

Page 21: ...ent of the cord or plug is necessary do not connect the grounding wire to either flat blade terminal The wire with insulation having an outer surface that is green with or without yellow stripes is the grounding wire Check with a qualified electrician or serviceman if the grounding instructions are not completely understood or if in doubt as to whether the product is properly grounded If is necess...

Page 22: ...nput out line Mains power quality should be that of atypical commercial or hospital environment Surge IEC61000 4 5 1kV for differential mode 2kV for common mode 1kV for differential mode 2kV for common mode Mains power quality should be that of atypical commercial or hospital environment Voltage dips short interruptions and voltage variations on power supply input lines IEC61000 4 11 5 UT 95 dip i...

Page 23: ...ity 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 reflection from structures objects and people a The ISM industrial scientific and medical bands between 150 kHz and 80 MHz are 6 765 MHz to 6 795 MHz 13 553 MHz to 13 567 M...

Page 24: ... a minimum distance between portable and mobile RF communications equipment transmitters and this device as recommended below according to the maximum output power of the communications equipment Separation distance according to frequency of transmitter m Rated maximum output power of transmitter W 150 kHz to 80 MHz P d 2 1 80 MHz to 800 MHz P d 2 1 800 MHz to 2 5 GHz P d 3 2 0 01 0 12 0 12 0 23 0...

Page 25: ...eanwhile TM XXXX X hr or CM XXXX X hr will start blinking and CLEAR will show on the LCD display 3 Press UP or DOWN The LCD screen will show CLEAR OK and the total meter or compliance meter record will be erased so the value becomes 0 0 hr 4 Press MENU to confirm the reset function 5 Press START STANDBY button to go back to standby screen or leave the device to automatically go back to standby scr...

Page 26: ...Drive Medical Design Manufacturing 99 Seaview Boulevard Port Washington NY 11050 516 998 4600 www drivemedical com ...

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