Breas Z1 User Manual Download Page 30 | Manualshive

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Doc. HD40-0007-02 En-Eu L-4

Symbol Explanation

The following symbols may appear on your device, power supply unit, or packaging.

Start/Stop

Serial number

Catalog number

Batch code

Caution

Class II equipment

Type BF equipment

Product disposal warning according to EN50419

Manufacturer

Date of Manufacture: YYYY-MM

Read user instructions

Degree of protection provided by enclosure.

Direct current

Not for use on more than one patient

CE marking applies in accordance with the directive MDD 93/42/EEC

Certified by Curtis-Straus

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Summary of Contents for Z1

Page 1: ...nt 16 Programming Treatment Pressure 16 Programming Ramp Mode 17 User Software 17 USB Firmware Upgrade 17 Charging the Battery PowerShell Only 19 Care 19 Inspections 19 CPAP Tube Replacement 20 Reminder Alert Air Leak Detection 21 Fault Conditions 21 Troubleshooting 22 Guidance and Manufacturer s Declaration Electromagnetic Emissions Immunity 24 Technical Specifications 28 Performance Specificatio...

Page 2: ...mputer This User Guide will help you take advantage of the features and capabilities of this amazing portable CPAP device Please read this User Guide carefully before using your Z1 Owner User Responsibility The owner user of the Z1 CPAP System is responsible for reading and understanding this User Guide The user is responsible for any injury or damage that results from Operation of the Z1 other th...

Page 3: ...g over 30 kg 66 lbs with obstructive sleep apnea OSA Contraindications Positive airway pressure therapy may be contraindicated in some individuals with the following pre existing conditions Severe bullous lung disease Pneumothorax Pathologically low blood pressure Dehydration Cerebrospinal fluid leak recent cranial surgery or trauma Adverse Effects Users should report unusual chest pain severe hea...

Page 4: ...AP masks or connectors which have vent holes to allow continuous flow of air out of the mask When your Z1 is turned on and functioning properly new air from the Z1 flushes the exhaled air out through the mask vent holes However when the Z1 is not operating properly e g at low pressure or the Z1 is off insufficient fresh air may be provided through the mask and the exhaled air may be rebreathed Reb...

Page 5: ...of bedding clothes or other objects that could block the air inlet or cover the Power Supply unit Only store or transport the Z1 and accessories within the storage and transport temperature humidity and altitude conditions specified in the Technical Specifications section of this User Guide Do not operate your Z1 Power Supply PowerShell or Battery in an area which may cause overheating Do not cove...

Page 6: ... For personal computers the international standard is IEC 60950 or equivalent CAUTIONS Be careful not to place your Z1 where it can be bumped or where someone is likely to trip over the power cord Make sure your Z1 Power Supply PowerShell and Battery are kept clean dry and free of dust Always make sure the power cord and plugs are in good condition and the equipment is not damaged before use Make ...

Page 7: ...e Battery backwards so that the polarity is reversed Do not connect the positive terminal and the negative terminal of the Battery to each other with any metal object such as wire Do not carry or store the Battery together with necklaces hairpins or other metal objects Do not pierce the Battery with nails strike the Battery with a hammer step on the Battery or otherwise subject it to strong impact...

Page 8: ...r or to the Power Supply plug Do not continue charging the Battery if it does not recharge within the specified charging time Doing so may cause the Battery to become hot rupture or ignite Remove the Battery from the PowerShell if the Z1 is not likely to be used for some time Do not use the Battery to power any device other than the Z1 Only use or charge the Battery within the operating temperatur...

Page 9: ...n Z1 Base Model Z1 Unplugged Z1 CPAP Device Power Supply with Power Cord USB A to Micro B Cable CPAP Tube Adapter CPAP Tube End Cap Filter Heat Moisture Exchange Unit HME Z1 CPAP Getting Started Guide User Guide Overnight Battery Battery Shuttle PowerShell PowerShell Getting Started Guide ...

Page 10: ...ment Follow the instructions provided with the tubing To purchase replacement tubing visit www breas com End Cap The End Cap attaches to the air intake end of the Z1 and houses the Filter For proper operation of the Z1 the Filter should be replaced monthly or more often if necessary Filter The Z1 uses a specially designed filter The material has been specifically chosen for the Z1 and has been des...

Page 11: ...g anything sharp when opening the packaging 3 Carefully inspect all contents against the Package Contents list on page 9 to assure all components are present Keep in mind that your health care provider might have completed some of the setup steps prior to delivery so if a component appears to be missing check to see if it has already been connected Also inspect all contents to ensure there is no o...

Page 12: ...1 passes through the Filter and no air bypasses the Filter 4 Press the End Cap onto the Z1 Figure 1 NOTE To remove the End Cap squeeze firmly on the sides of the End Cap and pull it away from the Z1 Tube Adapter CPAP Tube and Mask 1 Connect one end of the CPAP Tube to the round end of the Tube Adapter then insert the other end of the Tube Adapter into the outlet of the Z1 Figure 2 2 Connect the ot...

Page 13: ...d Battery Available Separately or as Part of Z1 Unplugged WARNING The Z1 must only be used with the optional Z1 PowerShell with Breas Battery or the Z1 Power Supply DO NOT use any other power source with the Z1 1 Slide the Battery with the attached Shuttle into the lower bay of the PowerShell until the Shuttle clicks into place Figure 6 NOTE The Battery can be removed from the PowerShell by pressi...

Page 14: ...en during loss of power For example a treatment pressure setting of 10 0 cmH2O is displayed in Figure 9 Ramp Progress Ramp Time Remaining Indicators Ramp Mode allows you to gradually acclimate to the prescribed treatment pressure Ramp Mode gradually increases the pressure from a low initial starting pressure to the prescribed treatment pressure over a programmed interval of time See Programming Ra...

Page 15: ... Solid Bars Charge Remaining 1 10 25 2 25 50 3 50 75 4 75 100 AC Power Indicator This icon is displayed when the Z1 is connected to an AC power outlet via the Power Supply General Status Display In standby mode this display field shows the current date During treatment it shows the currently selected Z Breathe setting 1 2 or 3 FAULT FAULT is displayed if one of several conditions has occurred that...

Page 16: ...n the PowerShell is typically 8 hours or longer and treatment will terminate when the charge is expended 2 Press the Start Stop Button a second time to stop treatment Programming Treatment Pressure When the Z1 is in standby mode press and hold the Start Stop Button for 3 seconds until the pressure value flashes While it is flashing repeatedly press either the Up or Down Arrow Buttons to increase o...

Page 17: ...ead of holding it down Setting Ramp Start Pressure Press and hold the Down Arrow Button for 3 seconds until the Ramp start pressure value flashes While flashing repeatedly press either the Up or Down Arrow Buttons to increase or decrease the Ramp start pressure by 0 5 cmH2O increment Figure 11 Ramp start pressure must be lower than prescribed pressure When the desired value for Ramp start pressure...

Page 18: ...g and for this reason we have created 3 levels of Z Breathe CPAP 1 offers mild pressure swing relief CPAP 2 is the Default Setting and offers moderate pressure swing relief CPAP 3 is the most aggressive setting for pressure swing relief You can change the setting of the Z Breathe Algorithm when your Z1 unit is in Standby Mode pressure of 0 0 indicated on the display To change the setting hold down...

Page 19: ...ll not charge unless the Z1 is in standby mode The Battery status indicator on the Z1 will flash when the Battery is charging The number of solid bars indicates the current level of charge Figure 14 The battery status indicator will stop flashing when the battery is fully charged Typically it will take 8 hours to fully charge the battery After a few minutes the back lit display will turn turn off ...

Page 20: ...the Tube Adapter to the Z1 and mask As Needed 1 Clean the exterior of the Z1 with a soft damp cloth and mild detergent and wipe clean Never submerge the Z1 in water Do not allow soap or water to enter the Z1 Filter Replacement The Filter should be inspected weekly for holes and blockage by dirt and dust and should be replaced every month or more often if necessary The Filter is accessed by removin...

Page 21: ...isplay the word FAULT on the LCD screen Figure 15 The LCD screen should be checked for any FAULT messages and visible damage daily A fault condition is indicated when the word FAULT is displayed accompanied by a two digit flashing number in place of the pressure reading The table below provides a listing of fault codes and recommended actions to be taken by the user Fault Code Explanation Action 2...

Page 22: ...eatment Will Not Start Check the display for a fault condition Refer to the Fault Codes table in Fault Conditions Contact Breas or your health care provider Insufficient Air Flow Delivered from Z1 Air filter is dirty or clogged Replace air filter Air intake is blocked Clear blockage CPAP Tube is not connected properly Check CPAP Tube Tube Adapter and connections to your Z1 and your mask Ramp Mode ...

Page 23: ...ent holes and the velocity of air coming up the tube Most users who have experienced this consider it to be white noise and a trade off for the convenience of the worlds smallest and light est CPAP If you experience this and it is a problem for you there are three steps that you can try to help minimize this Place the HME between the end of your tube and the mask Try a standard bore 22mm CPAP Tube...

Page 24: ...nment guidance RF emissions CISPR 11 Group 1 The Z1 CPAP System uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interfer ence in nearby electronic equipment RF emissions CISPR 11 Class B The Z1 CPAP System is suitable for use in all establishments including domestic establish ments and those directly connected to the public low ...

Page 25: ...ne s to line s 2 kV line s to earth 1 kV line s to line s 2 kV line s to earth Mains power quality should be that of a typical commercial or hospital environment Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 5 UT 95 dip in UT for 0 5 cycle 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip in UT for 25 cycles 5 UT 95 dip in UT for 5 sec 5 UT 95 dip in...

Page 26: ...eld strengths from fixed RF transmit ters as deter mined by an electromag netic site survey a should be less than the compliance level in each frequency range b Interference may occur in the vicinity of equipment marked with the following symbol 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 aff...

Page 27: ...on 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 ob...

Page 28: ...t IEC 60601 1 classification Class II double insulation Type BF Available modes Standby CPAP Auto CPAP and CPAP Auto CPAP with Ramp Sound pressure level 26 dBA Nominal dimensions L x W x H 16 46 cm x 8 38 cm x 5 13 cm 6 48 x 3 30 x 2 02 Weight 284 g 10 oz Housing construction Flame retardant engineered thermoplastic Supplemental oxygen Not for use with oxygen Standard air filter Polyester Air outl...

Page 29: ...pped with between 30 and 50 rated capacity providing a minimum of 6 months shelf life when stored at 25 C If storage tempera ture exceeds 25 C over 6 month period then shelf life will be reduced and battery should be recharged periodically Storage and transport temperature 20ºC to 60ºC 4ºF to 140ºF Storage and transport humidity 80 Relative Humidity Non Condensing Battery Technology Lithium Ion Ba...

Page 30: ... number Batch code Caution Class II equipment Type BF equipment Product disposal warning according to EN50419 Manufacturer Date of Manufacture YYYY MM Read user instructions Degree of protection provided by enclosure Direct current Not for use on more than one patient CE marking applies in accordance with the directive MDD 93 42 EEC Certified by Curtis Straus ...

Page 31: ...mponents This limited warranty does not cover a any damage caused as a result of accident improper use abuse modification or alteration of the product b repairs carried out by any service organization that has not been expressly authorized by Breas to perform such repairs c any damage or contamination due to cigarette pipe cigar or other smoke d damage caused by water entering the product Warranty...

Page 32: ...custom tip for software downloads and data extraction Slim Style Tube Special lightweight thin pressure delivery tube for use with the Z1 Device Z1 Polyester Filter 2 pack 2 each Z1 Polyester Air Filters Z1 Polyester Filter 6 pack 6 each Z1 Polyester Air Filters Z1 Custom Tube Adapter Z1 custom outlet Tube Adapter required for Z1 operation Heat Moisture Exchange Unit HME In line humidification for...

Page 33: ...the carrier provided they have been tested for Electromagnetic Compatibility EMC in accordance with the current version of RTCA DO 160 Section 21 Category M Breas Medical has successfully completed testing for the Z1 CPAP System The Z1 CPAP System complies with RTCA DO 160 Section 21 Category M and can be considered FAA compliant Some airlines may require advance notification before travel and dev...

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Page 35: ...435 33 Mölnlycke SWEDEN About you NAME First Last EMAIL ADDRESS MAILING ADDRESS Street or PO Box City Zip PHONE NUMBER About the device WHAT DEVICE DID YOU PURCHASE WHERE DID YOU PURCHASE THE DEVICE PURCHASE DATE ____ ____ ____ YY MM DD Z1 SERIAL NUMBER POWERSHELL SERIAL NUMBER The device serial number can be found on the back of the unit Look for the string of numbers following 11042013 ...

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