BMC U Series User Manual

BMC U Series User Manual

Resmart gii bpap system heated humidifier
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User Manual
RESmart GII BPAP System
Y / U Series
User Manual
Heated Humidifier
H60
English

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Summary of Contents for BMC U Series

  • Page 1 User Manual RESmart GII BPAP System Y / U Series User Manual Heated Humidifier English...
  • Page 2 User Manual RESmart GII BPAP System Y / U Series...
  • Page 3: Table Of Contents

    RESmart GII BPAP System Y / U Series User Manual V2.1 Table of Contents 1. Symbols ·································································································· 1 1.1 Control Buttons ················································································ 1 1.2 Device Symbols ················································································ 1 2. Warning, Caution and Important Tip ······························································· 3 3. Intended Use ···························································································· 3 4.
  • Page 4 RESmart GII BPAP System Y / U Series User Manual V2.1 15.4 Cleaning the Enclosure ···································································· 30 15.5 Cleaning the Tube ·········································································· 30 15.6 Replacing the Air Filter ···································································· 31 15.7 Disinfection ·················································································· 31 16. Traveling with the Device ··········································································· 32 17.
  • Page 5: Symbols

    RESmart GII BPAP System Y / U Series User Manual V2.1 1. Symbols 1.1 Control Buttons Ramp Button Mute Button Knob 1.2 Device Symbols Follow Instructions for Use Operating Instructions Type BF Applied Part (mask) Class II (Double Insulated) For indoor use only AC Power DC Power IP22...
  • Page 6 RESmart GII BPAP System Y / U Series User Manual V2.1 Non-Ionizing Radiation SD Card Water Filling Prohibited Here Water Inlet Directional Indicator for Removing the Water Inlet Cap Directional Indicator for Screwing the Water Inlet Cap WEEE Marking Logo of BMC Medical Co., Ltd. 2 / 42...
  • Page 7: Warning, Caution And Important Tip

    • The instructions in this manual are not intended to supersede established medical protocols. • To ensure that you receive the safe, effective therapy prescribed for you, use only BMC accessories. • Do not bring the device or accessories into a Magnetic Resonance (MR) environment as it may cause unacceptable risk to the patient or damage to the device or MR medical devices.
  • Page 8: Contraindications

    RESmart GII BPAP System Y / U Series User Manual V2.1 • Cleaning and disinfection can be performed by the patient. IMPORTANT! • Read and understand the entire user manual before operating this system. If you have any questions concerning the use of this system, contact your home care provider or health care professional.
  • Page 9: Specifications

    RESmart GII BPAP System Y / U Series User Manual V2.1 5. Specifications Device Size Dimensions: 170 mm × 180 mm × 118 mm, or 290 mm × 180 mm × 134 mm (with the humidifier) Weight: 1.5 kg, or 2.5 kg (with the humidifier) Product Use, Transport and Storage Operation Transport and Storage...
  • Page 10 RESmart GII BPAP System Y / U Series User Manual V2.1 Pressure Display Accuracy ± (0.8 hPa+4%) Static Pressure Stability ± 0.5 hPa Ramp The ramp time ranges from 0 to 60 minutes. Sound Pressure Level < 30 dB, when the device is working at the pressure of 10 hPa. Sound Power Level <...
  • Page 11: Available Therapies

    RESmart GII BPAP System Y / U Series User Manual V2.1 6. Available Therapies The device delivers the following therapies: CPAP – Delivers Continuous Positive Airway Pressure; CPAP maintains a constant level of pressure throughout the breathing cycle. If your health care professional has prescribed ramp for you, you can press the Ramp Button to reduce the pressure and then gradually increase the pressure to the therapeutic pressure setting so that you can fall asleep...
  • Page 12: Glossary

    RESmart GII BPAP System Y / U Series User Manual V2.1 7. Glossary Apnea A condition marked by the cessation of spontaneous breathing. Auto-CPAP Adjust CPAP pressure automatically to improve patient comfort based on monitoring of apnea and snoring events. Auto Off When this feature is enabled, the device automatically discontinues therapy whenever the mask is removed.
  • Page 13 RESmart GII BPAP System Y / U Series User Manual V2.1 Res Rate Respiratory Rate. Number of breaths per minute. Reslex A therapy feature that is enabled by your home care provider to provide pressure relief during exhalation. Standby State The state of the device when power is applied but the airflow is turned off.
  • Page 14: Model

    RESmart GII BPAP System Y / U Series User Manual V2.1 8. Model Product Contents Maximum Work Model Work Mode Optional Pressure Main Device Accessory (hPa) Main device Y-20T (3.5-inch CPAP, S, S/T, T LCD) Main device Y-25T (3.5-inch CPAP, S, S/T, T LCD) Main device Y-30T...
  • Page 15: Package Contents

    • This device should only be used with the mask and accessories manufactured or recommended by BMC or with those recommended by your prescribing physician. The use of inappropriate masks and accessories may affect the performance of the device and impair the effectiveness of therapy.
  • Page 16: System Features

    • When the insulation layer of the SpO probe cable is damaged, do not connect the probe to the patient. • Please contact BMC to buy the SD card if you need it. 10. System Features Humidifier Indicator Display Screen...
  • Page 17: First Time Setup

    RESmart GII BPAP System Y / U Series User Manual V2.1 SD Card Slot Communications Port DC Inlet Filter Cap Fig. 10-2 Name Function SD Card Slot Insert the SD card into this slot Connected to SpO Kit, Wi-Fi Kit, Cellular Module, SpO &Wi-Fi Communications Port Kit or SpO...
  • Page 18: Installing The Air Filter And Filter Cap

    RESmart GII BPAP System Y / U Series User Manual V2.1 • Tobacco smoke may cause tar build-up within the device, leading to the malfunctioning of the device. • Air must flow freely around the device for it to work properly. 11.2 Installing the Air Filter and Filter Cap (1) Attach the air filter to the filter cap, as shown in Fig.
  • Page 19: Connecting To Power Cord Locker

    RESmart GII BPAP System Y / U Series User Manual V2.1 WARNINGS! • The device is powered on for use when the power cord and power adapter is connected. The Knob turns the blower On / Off. • Use of the device at an AC voltage beyond the stated range (see Section 5 “AC Power Consumption”) may damage the device or cause device failure.
  • Page 20: Assembling The Tube And Mask

    - Use the accompanying tube and mask provided by BMC. - Do not wear the mask for more than a few minutes while the device is not operating. - Use only masks with vent holes. Do not block or try to seal the vent holes in the exhalation port.
  • Page 21: Using Oxygen With The Device

    RESmart GII BPAP System Y / U Series User Manual V2.1 11.6 Using Oxygen with the Device Oxygen may be added at the mask connection. Please observe the instructions listed below when using oxygen with the device. WARNINGS! • Connect the oxygen tube to the oxygen inlet of the mask. •...
  • Page 22: Using Optional Kits

    RESmart GII BPAP System Y / U Series User Manual V2.1 Fig. 11-9 If the SD card is inserted incorrectly or not inserted, a symbol indicating incorrect insertion or no SD card present will appear in the Main Interface on the screen of the device, as shown in Fig.
  • Page 23: Routine Use

    • Be sure to follow your physician’s instructions on adjusting the settings! To order any accessories not included with this device, contact your equipment supplier. • DO NOT connect any ancillary equipment to this device unless recommended by BMC or your physician. If you suffer from chest discomfort, shortness of breath, stomach bloating, or severe headache when using the device, contract your physician or qualified medical personnel immediately.
  • Page 24: Turning The Device Off

    RESmart GII BPAP System Y / U Series User Manual V2.1 CAUTIONS! • You can press the Ramp Button as often as you wish during sleep. • The ramp feature is not prescribed for all users. 12.6 Turning the Device Off Take off the mask and headgear, press and hold the Knob for two seconds, and the device will stop delivering air.
  • Page 25: Accessing The Setup Interface

    RESmart GII BPAP System Y / U Series User Manual V2.1 Fig. 13-3 The first icon on the left side of the screen indicates the Main Interface, the second icon indicates the Initial Setup Interface, and the third icon indicates the iCode Interface.
  • Page 26: Confirming Adjustments

    RESmart GII BPAP System Y / U Series User Manual V2.1 indicating a lower humidity level. At this moment, the Humidifier option is still displayed in yellow, as shown in Fig. 13-6. Fig. 13-6 13.1.6 Confirming Adjustments Confirm your adjustment to an option by pressing the Knob .
  • Page 27 RESmart GII BPAP System Y / U Series User Manual V2.1 Fig. 13-9 Press the Knob , the cursor jumps to the second icon on the left side of the screen. The screen displays the Initial Setup Interface, as shown in Fig. 13-10. Fig.
  • Page 28: Options Of The Patient Menu And Corresponding Descriptions

    RESmart GII BPAP System Y / U Series User Manual V2.1 13.2 Options of the Patient Menu and Corresponding Descriptions Option Range Description There are five humidity levels available. As the numbering Off, 1 ~ 5 Humidifier increases, the humidity rises accordingly. “Off” means the humidifier is turned off.
  • Page 29: Alarm

    RESmart GII BPAP System Y / U Series User Manual V2.1 Show the relevant information about the device, this is only for Model; SN; users to view, can not be modified. Model: the device model; Firmware About SN: Serial Number of the device; Firmware version: Software version;...
  • Page 30: Alarming Silence

    RESmart GII BPAP System Y / U Series User Manual V2.1 In accordance with the requirements of the relevant standards, the volume of the audible alarm signal meets the requirements, and the sound pressure range of the measured auditory alarm signal is described as follows: Measured A-weighted sound sound...
  • Page 31 RESmart GII BPAP System Y / U Series User Manual V2.1 setting is “20 hPa”. Off, 5 ~ 26 hPa applies to Y-25T and U-25T, in 0.5 hPa increments, the default setting is “25 hPa”. Off, 5 ~ 31 hPa applies to Y-30T, U-30T and U-30AT, in 0.5 hPa increments, the default setting is “30 hPa”...
  • Page 32 RESmart GII BPAP System Y / U Series User Manual V2.1 When the airflow is on, an audible alert Middle Function will sound if the vents of the mask are Mask Blocked!! blocked; the screen will display “Mask Priority Alarm Blocked!!”...
  • Page 33: Alarming Journal

    RESmart GII BPAP System Y / U Series User Manual V2.1 14.6 Reposition of Alarming After the elimination of the alrming faults, the residual alarming information still exists (alarming information is shown on the top of the screen without any visual and auditory alarming), and turn the button leftwards or rightwards to reduce the residual alarming information.
  • Page 34: Cleaning And Disinfection

    RESmart GII BPAP System Y / U Series User Manual V2.1 15. Cleaning and Disinfection WARNINGS! • Regular cleaning of the device and its accessories is very important for the prevention of respiratory infections. • To avoid electric shock, always unplug the device before cleaning. •...
  • Page 35: Replacing The Air Filter

    RESmart GII BPAP System Y / U Series User Manual V2.1 (2) Clean the tube in warm water which contains washing liquid, and then rinse it in clean water thoroughly. (3) After cleaning, air-dry the tube in a cool, well-ventilated area, and avoid direct sunlight. It takes approximately 30 minutes to completely air-dry the tube.
  • Page 36: Traveling With The Device

    • If the device is used when the atmospheric pressure is out of the stated range (See Section 5), the accuracy of the leakage alert will be affected. (1) Use the BMC carrying case to carry the device and accessories along with you. Do not put them in your checked baggage.
  • Page 37: Transferring The Device To Another Patient

    19. Technical Support Please contact BMC directly if you need the circuit diagram of the device and the list of components for certain purposes such as maintenance or connection to other equipment. BMC will provide the circuit diagram and / or other technical documents in whole or in part according to your needs.
  • Page 38: Troubleshooting

    RESmart GII BPAP System Y / U Series User Manual V2.1 21. Troubleshooting The table below lists common problems you may have with the device and possible solutions to those problems. If none of the corrective actions solve the problem, contact your home care provider.
  • Page 39 RESmart GII BPAP System Y / U Series User Manual V2.1 Turn the humidity setting down, or raise the room temperature. When the humidifier is used, Place the tube under the quilt, or the humidified air tends to use the tube cover. Water in mask condense in the cold tube and mask if the room temperature...
  • Page 40: Common Problems In The Device And Corresponding Solutions

    RESmart GII BPAP System Y / U Series User Manual V2.1 21.2 Common Problems in the Device and Corresponding Solutions Problem Possible Cause Solution (s) Take a few deep breaths with the The Auto On / Off feature is mask on, and the device will start enabled automatically Ensure that the power cord,...
  • Page 41: Emc Requirements

    RESmart GII BPAP System Y / U Series User Manual V2.1 22. EMC Requirements Guidance and manufacturer's declaration - electromagnetic emissions The device is intended for use in the electromagnetic environment specified below. The user of the device should ensure that it is used in such an environment. Electromagnetic Environment - Emissions Test Compliance...
  • Page 42 RESmart GII BPAP System Y / U Series User Manual V2.1 Guidance and manufacturer's declaration - electromagnetic immunity The device is intended for use in the electromagnetic environment specified below. The user of the device should make sure that it is used in such an environment. Immunity IEC 60601 Compliance...
  • Page 43 RESmart GII BPAP System Y / U Series User Manual V2.1 Guidance and manufacturer's declaration - electromagnetic immunity The device is intended for use in the electromagnetic environment specified below. The user of the device should make sure that it is used in such an environment. Immunity Compliance Electromagnetic Environment -...
  • Page 44 RESmart GII BPAP System Y / U Series User Manual V2.1 Recommended separation distances between portable and mobile RF communications equipment and the device The device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the device as recommended below, according to the maximum output power of the communications equipment.
  • Page 45 RESmart GII BPAP System Y / U Series User Manual V2.1 Recommended separation distances between RF wireless communications equipment The device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the device can help prevent electromagnetic interference by maintaining a minimum distance between RF wireless communications equipment and the device as recommended below, according to the maximum output power of the communications equipment.
  • Page 46: Limited Warranty

    (1) year for main unit and three (3) months for all accessories from the date of sale by BMC Medical Co., Ltd. to the dealer. If the product fails to perform in accordance with the product specifications, BMC Medical Co., Ltd. will repair or replace, at its option, the defective material or part.
  • Page 47 User Manual Heated Humidifier 0123...
  • Page 48 H60 Heated Humidifier User Manual V2.0 The H60 Heated Humidifier is designed only for use with specific RESmart GII devices. Do not use the H60 Heated Humidifier with any other devices. The humidifier moistens the air delivered by the RESmart GII devices. It is for use in the home or hospital / institutional environment.
  • Page 49: Warning, Caution And Important Tip

    H60 Heated Humidifier User Manual V2.0 1. Warning, Caution and Important Tip WARNING! Indicate the possibility of injury to the user or operator. CAUTION! Indicate the possibility of damage to the device. IMPORTANT TIP! Place emphasis on an operating characteristic. Warnings, Cautions, and Important Tips appear throughout this manual as they apply.
  • Page 50: Features

    Have any damaged parts replaced before continuing use. • Read all instructions before using the humidifier. • Use only with BMC devices whose instructions specify the use of this humidifier. • Please use the mask which meets ISO17510:2015.
  • Page 51: Connecting, Separating The Humidifier And Main Device

    WARNINGS! • Use the humidifier only for its intended use as described in this manual. • Use only accessories recommended by BMC. • Do not bring the device or accessories into a Magnetic Resonance (MR) environment as it may cause unacceptable risk to the patient or damage to the device or MR medical devices.
  • Page 52: Separating The Humidifier From The Main Device

    H60 Heated Humidifier User Manual V2.0 CAUTION! • When the main device delivers air and the humidity setting is adjusted, if the indicator lights of the humidifier do not light up, it may be that the humidifier and main device are not connected correctly.
  • Page 53: Overturning The Water Chamber

    H60 Heated Humidifier User Manual V2.0 Humidifier Uncover Button Fig. 4-5 WARNING! • Turn the device off and allow approximately 15 minutes for the heater plate and water to cool. 4.2.2 Overturning the Water Chamber Turn the water chamber over so that it is bottom up, as shown in the figure below. Fig.
  • Page 54: Returning The Water Chamber

    H60 Heated Humidifier User Manual V2.0 Water Inlet Cap Maximum Water Level Line 1/4 Maximum Water Level Line Fig. 4-8 WARNING! • Every time before treatment, be sure to drain any residual water out of the water chamber, and ensure the maximum water level line is not submerged by water. CAUTIONS! •...
  • Page 55 H60 Heated Humidifier User Manual V2.0 chamber base, and pour any remaining water out of the main body of the water chamber. Undo the Water Chamber Buckle, and open the water chamber as shown below. Water Chamber Buckle Fig. 4-10 CAUTION! •...
  • Page 56: Setting The Humidity Level

    H60 Heated Humidifier User Manual V2.0 4.4 Setting the Humidity Level After the main device is powered on, turn the Knob to turn on or turn off the humidifier and to adjust the humidity level according to instructions on the screen of the main device. There are five humidity levels available, and the number of blue indicator lights that light up is directly proportional to the humidity level.
  • Page 57: Cleaning

    H60 Heated Humidifier User Manual V2.0 5. Cleaning Clean the water chamber before first use of the humidifier or at least once every week. If the humidifier has not been in use for a long time, clean the water chamber before reusing it. WARNING! •...
  • Page 58: Detaching The Air-Intake Assembly

    H60 Heated Humidifier User Manual V2.0 5.3 Detaching the Air-intake Assembly After the water chamber is removed, detach the Air-intake Assembly from the main body of the humidifier by pulling it upwards, as shown in the figure below. Air-intake Assembly Fig.
  • Page 59: Cleaning The Air-Intake Assembly

    H60 Heated Humidifier User Manual V2.0 (dip the soft cloth in washing liquid if necessary), rinse them throughly, and then wipe them dry with a soft cloth. Fig. 5-5 (3) Assembling the Water Chamber: Place the two parts of the water chamber together as shown in Fig.
  • Page 60: Reassembling The Humidifier

    H60 Heated Humidifier User Manual V2.0 water chamber (dip the soft cloth in mild scrubbing solutions if necessary), then rinsed thoroughly, and at last wiped with soft cloth. Top Cover Main Body Fig. 5-8 5.7 Reassembling the Humidifier (1) Set up the air-intake assembly: First install the sealing elements to the air intake, as shown in the figure below.
  • Page 61: Disinfection

    H60 Heated Humidifier User Manual V2.0 Fig. 5-11 (4) Connect the top cover and main body of the humidifier properly, as shown in the figure below. Fig. 5-12 6. Disinfection Generally speaking, if you have strictly followed the above cleaning instructions, you do not have to disinfect the humidifier.
  • Page 62: Service

    The humidifier does not require routine servicing. If the humidifier malfunctions, contact your home care provider immediately. Never attempt to open the humidifier’s enclosure. If necessary, contact your local authorized dealer or BMC Medical Co., Ltd. for technical support and documents.
  • Page 63: Disposal

    H60 Heated Humidifier User Manual V2.0 Pressure Drop with Humidifier < 0.4 hPa at 60 LPM flow Humidifier Performance Humidity Output: No less than 10 mg H Environmental Conditions: Maximum airflow, 35°C, 15% relative humidity Maximum Delivered Gas Temperature < 43°C The Form and the Dimensions of the Patient Connection Port The 22 mm conical air outlet complies with ISO 5356-1.
  • Page 64: Emc Requirements

    H60 Heated Humidifier User Manual V2.0 11. EMC Requirements Guidance and manufacturer's declaration - electromagnetic emissions The device is intended for use in the electromagnetic environment specified below. The user of the device should ensure that it is used in such an environment. Electromagnetic Environment - Emissions Test Compliance...
  • Page 65 H60 Heated Humidifier User Manual V2.0 Guidance and manufacturer's declaration - electromagnetic immunity The device is intended for use in the electromagnetic environment specified below. The user of the device should make sure that it is used in such an environment. 60601 Compliance Electromagnetic...
  • Page 66 H60 Heated Humidifier User Manual V2.0 Guidance and manufacturer's declaration - electromagnetic immunity The device is intended for use in the electromagnetic environment specified below. The user of the device should make sure that it is used in such an environment. Immunity IEC 60601 Compliance...
  • Page 67 H60 Heated Humidifier User Manual V2.0 Recommended separation distances between portable and mobile RF communications equipment and the device The device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the device as recommended below, according to the maximum output power of the communications equipment.
  • Page 68 H60 Heated Humidifier User Manual V2.0 Recommended separation distances between wireless communications equipment The device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the device can help prevent electromagnetic interference by maintaining a minimum distance between RF wireless communications equipment and the device as recommended below, according to the maximum output power of the communications equipment.
  • Page 69: Warranty

    BMC Medical Co., Ltd. will repair or replace, at its option, the defective material or part. BMC Medical Co., Ltd. will pay customary freight charges from BMC Medical Co., Ltd. to the dealer location only.
  • Page 70 390729...

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