Northern Meditec Crius V2 User Manual

Positive airway pressure device

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User Manual

Positive Airway Pressure Device

For this User Manual,the updating date is 2025.02.06

User Manual Document No./Version: NR-TU-0316-110 /1.3

Manufacturer:

Northern Meditec Limited

Address: Room501,502 Building A,Room 401 Building C, JinWeiYuan Industrial Area No.41 Qingsong

Road,Zhukeng Community, Longtian Sub-district, Pingshan District, 518118 Shenzhen City, P.R.China

Website: www.northernmeditec.com

E-mail Address: info@northernmeditec.com

Tel: +86 755 27952733

Fax: +86 755 86528647

Page 1 of 34

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Page 1 User Manual Positive Airway Pressure Device ©2022 ShenZhen Northern Meditec Limited.All rights Reserved. For this User Manual,the updating date is 2025.02.06 User Manual Document No./Version: NR-TU-0316-110 /1.3 Manufacturer: Northern Meditec Limited Address: Room501,502 Building A,Room 401 Building C, JinWeiYuan Industrial Area No.41 Qingsong Road,Zhukeng Community, Longtian Sub-district, Pingshan District, 518118 Shenzhen City, P.R.China...
Page 2: Table Of Contents
Content 1 Welcome....................................3 2 Intended Use ..................................3 3 Contraindications ................................3 4 Safety Information ................................4 5 Symbol ....................................7 6 System Contents ................................10 7 System Overview ................................10 7.1 Placing the Device ............................10 7.2 Supplying AC Power ............................11 7.3 Connecting the Breathing Circuit and Mask ..................11 7.4 Water-filling Operation ...........................
Page 3: Welcome
1 Welcome The positive airway pressure device includes the following models: Crius V2-20、Crius V2-25S、Crius V2-25ST、Crius V2-25PC、 Crius V2-25 Pro、Crius V2-30S、Crius V2-30T、 Crius V2-30ST、Crius V2-30PC、Crius V2-30 Pro. Manufacturer Responsibility Northern is responsible for the effects on safety, reliability,and performance of this product, only if: All installation operations, expansions, changes, modifications, and repairs of this product are conducted by...
Page 4: Contraindications
3 Contraindications Absolute contraindications：  Patient refusal.  Respiratory or Cardiac arrest.  Agonal respirations.  Major trauma (i.e. head injury with increased intra cranial pressure)  Inability to maintain airway patency due to reduced GCS  Broncho-pleural fistula.  Surgical anastomosis involving intra thoracic procedures, including but not limited to oesophagus/stomach/trachea and larynx (i.e.
Page 5 The device is not used to exceed the specified temperature range. Do not be in direct light (including sunlight) or near a heating appliance because these conditions can increase the temperature of the air coming out of the device. Please replace the filter cotton and clean the machine regularly to prevent the accumulation of dust and cotton wool from affecting the performance of the machine;...
Page 6 expired gases. Be careful to clean it often. Do not use the humidifier at an altitude above 3000m or outside a temperature of 35℃. Using the humidifier outside of this temperature range or above this altitude can affect the quality of the therapy or injure the patient. ...
Page 7: Symbol
environment.The reason is that they may touch the machine and endanger the life of the patient. In case you feel comfortless when you contact the device. You shall stop to use the device and contact your supplier immediately. Because it may cause allergic reactions. Please periodically reassess the setting(s) of the effectiveness of therapy.
Page 8 Symbol Definition Temperature limitations at transport and storage Humidity limitations at transport and storage Atmospheric pressure at transport and storage Follow instruction for use Caution Dispose according to Council Directive 2012/19/EU or WEEE (Waste Electrical and Electronic Equipment) Indicates the degree of protection against electric shock according to IEC 60601-1. Class II devices have double or reinforced insulation, as they have no provision for protective grounding Indicates the degree of protection provided by enclosure according to IEC 60601-1...
Page 9 Symbol Definition Fragile Keep dry at transport and storage Stacking limitations Recyclable materials Medical device Unique device identifier Page 9 of 34...
Page 10: System Contents
6 System Contents Your device may include the following items: Positive airway pressure device host Power Adapter Power Cord Travel Bag User Manual Note: If any of these items are missing, please contact your home care provider. 7 System Overview Device Feature Description Humidifier flip cover...
Page 11: Supplying Ac Power
Do not place the device directly onto carpet, fabric, or other flammable materials. Do not place the device in or on any container that can collect or hold water. Do not contact the metal surface of the heater when pulling out the water tank. 7.2 Supplying AC Power Complete the following steps to operate the device using AC power: 1.
Page 12 To connect your breathing circuit to the device, please follow the below steps: 1. Connect the hose to the port on the back of the positive airway pressure device. 2. Connect the tubing to the mask. For specific parameters and the correct use of the method, please refer to the breathing hose manual.
Page 13: Water-Filling Operation
user should check the mask and tube for damage before each use. If necessary, place a filter cotton in the air outlet of the unit and connect the tube. The use of filter cotton may affect the equipment work. However, the device can remain functional and be treated. 7.4 Water-filling Operation 1.
Page 14: Operation
To adjust a setting: 1. Rotate the control dial to your desired menu option. 2. Press the control dial to select that setting. 3. Rotate the control dial to change the setting. 4. Press the control dial again to save the change. Note: The screens shown throughout this manual are examples for reference only.
Page 15: Standby Interface
interface). 9.2.1 Standby Interface The Standby Interface displays setup menus for the system’s main features，and the icons to indicate the current enabled features. Figure1 Standby Interface Figure2 Standby Interface - Doctor Settings *Long press the "Ramp"and the control dial simultaneously to enter the doctor setting interface Icon Description Time...
Page 16: Menu Interface
Figure3 Ventilation-parameter monitoring interface Figure4 Ventilation-parameter waveform interface Description Current treatment mode (e.g. "T") Real-time monitoring of parameter items The parameter waveform interface is displayed 9.2.3 Menu interface 9.2.3.1 Menu-System Setting Rotate the control dial, Select [Menu] - Press the control dial - Enter the system setting interface； Or click [Menu] - Enter the system setting interface.
Page 17 Language Set the system interface language Option: English / Chinese Default:English Set the Energy Saving function on or off. When Energy Saving is off, the screen will be turned off automatically if there is no Energy Saving operation within 10s in standby mode or 10s in therapy mode. Option: ON / OFF Default: ON Date...
Page 18 Figure 6 Menu - Report Figure 7 Menu - Report - More information Item Description Set the time interval covered by the report. Period Options: 3 days / 1 week / 1 month Usage Number of hours the device has been used in the selected period Use three stars for rating the leakage of mask in the selected period The mask seal status is good Mask fit...
Page 19: Mode Selection Interface
Figure 8 Menu - Comfort Setting Interface Feature Description Set the humidity level. Humidity level The value range is Off /1-5, Default: Off When the Preheat is on, the humidifier starts preheating in the standby mode and the Preheat maximum preheating time is 30 minutes. In the therapy mode, the preheating stops Option: ON / OFF Default: OFF Set the Tube type...
Page 20 model Description Continuous positive airway pressure ventilation mode CPAP CPAP breathing mode has the same therapeutic pressure in the inspiratory and expiratory phases Spontaneous breathing mode S mode is the spontaneous breathing mode, and the working process is based on the patient's inspiratory trigger to provide inspiratory pressure IPAP, and expiratory trigger to provide respiratory pressure EPAP.
Page 21: Tf Card
disappears, it switches to T mode and carries out ventilation treatment according to the preset breathing cycle. A/C-PC Increase the patient's airway pressure to the set pressure level according to the set pressure rise time during the inspiratory stage and maintain it until the end of the inspiratory time and then turn to exhalation.
Page 22 Alert Possible Cause Action Please replace it exceeds the set service time humidifier The filter is expired. The service time of the filter Click "Confirm" and replace the Please replace it exceeds the set service time filter The mask is expired. The service time of the mask Click "Confirm"...
Page 23: Troubleshooting
11.Troubleshooting If your device has the following problems in the usage, please try the following measures. If it can’t be resolved, please contact the maintenance provider. Problem Possible Cause Action Check the outlet and verify that the device is properly plugged in.
Page 24: Maintaining
Problem Possible Cause Action problem continues, contact your provider The touchscreen is Unplug the device. Reapply power to the device. If the Touch screen failure insensitive problem continues, contact your provider 12. Maintaining To avoid prolonged exposure to a dusty and humid environment, resulting in impaired performance and reliability, the user must maintain the device regularly.
Page 25: Traveling With The Device
1. Open the air filter cover at the back of the device. 2. Remove and discard the old air filter. 3. Insert a new air filter. 4. Close the air filter cover. 12.4 Traveling with the Device Use the Northern travel bag to carry the device and accessories when traveling. Please follow the below steps for packing: 1.
Page 26: Storage
14.1 Storage 14.1.1 Storage Information Store the device under the prescribed ambient conditions. (See ”Specification”) 14.1.2 Storing the therapy device. Switch off the therapy device. Disconnect the therapy device from the power supply. Clean the therapy device, components, and accessories. Store the therapy device, components, and accessories in a dry place.
Page 27: Specification
15 Specification The technical specifications of the equipment are as follows: Table 1: Item Specifications Physical Dimension (L*W*H): mm 248 x 196 x110 mm Weight Approximately 1.6kg Operating Temperature 5ºC ~ 35 ºC Environmental Relative Humidity 10% ~ 95%(non-condensing) Atmospheric Pressure 70kPa~ 106kPa Storage Temperature...
Page 28 4cmH O:≥140L/min;8cmH O:≥140L/min; Maximum gas flow 12cmH O:≥140L/min;16cmH O:≥140L/min;20cmH O:≥110L/min Range:100～900ms Rise time Range:5～50bpm; Respiratory rate（S/T、T mode） Accuracy:±1bpm Insp Trig Auto,1~5 Exp Trig Auto,1~5 100~2000mL Parameter monitoring Range:0～30cmH Display resolution:0.1cmH Pressure Accuracy: ±(0.5cmH O+4% of the reading) Range:0~4000ml; Display resolution:1mL Accuracy: Tidal volume 0-2000ml：±20% of the reading；...
Page 29 Table 3 Range The temperature of heater plate（℃） 40±4 45±4 50±4 55±4 60±4 c)Humidification output: NO less than 10mg/L. Note1: The table above dynamic is based on data that covers between 60.1 and 88.8% of the inspiratory phase and 66.1 and 93.4% of the expiratory phase durations.
Page 30 Guidelines and manufacturer's statements are detailed in the attachment. Crius V2 series positive airway pressure devices should not be used close to or stacked against other equipment, and if they must be used close to or stacked, they should be observed and verified to function properly in the configuration in which they are used.
Page 31 Emissions test Compliance Electromagnetic environment -guidance Positive airway pressure device uses RF energy only for its internal function. Therefore, its RF emissions are very low and Radiated emissions CISPR11 Group 1 are not likely to cause any interference in nearby electronic equipment.
Page 32 network voltage before the Note: UT refers to the airway pressure device be test voltage is applied AC network voltage powered by an uninterruptible before the test voltage power supply or battery. is applied The power frequency magnetic field should have Power frequency the horizontal characteristics （50/60Hz）...
Page 33 If the field intensity of Crius V2 series positive airway pressure device is higher than the RF conformance level of the above application, the Crius V2 series positive airway pressure device should be observed to verify its normal operation.If abnormal performance is observed, complementary measures may be necessary, such as reorientation or positioning of the Crius V2 series positive airway pressure device.
Page 34 For the rated maximum output power of the transmitter not listed in the above table, the recommended Separation distance d, in meters (m), can be determined by the formula in the corresponding transmitter frequency. Where, P is the maximum output power rating of the transmitter in watts (W). Note 1: At 80MHz and 800MHz frequencies, the formula of the higher frequency band is used.

This manual is also suitable for:

Crius v2-20 Crius v2-25s Crius v2-25st Crius v2-25pc Crius v2-25 pro Crius v2-30s ... Show all