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MASIMO EMMA Capnograph Kit

MASIMO-EMMA-Capnograph-Kit-PRODUCT

Техникалык шарттар

  • Модел: Radius PCGTM (EMMA Bluetooth)
  • Өлчөө: Carbon dioxide partial pressure and respiratory rate
  • Максаттуу колдонуу: Anesthesia, recovery, and respiratory care for adult, pediatric, and infant patients
  • Байланыш: Bluetooth wireless technology

Продукт Description
The Radius PCGTM is a quantitative mainstream carbon dioxide monitor that consists of a Sensor Body fitting on top of a disposable EMMA Airway Adapter. It can connect to other devices using Bluetooth wireless technology.

Максаттуу колдонуу

The Radius PCGTM is designed to measure, display, and monitor carbon dioxide partial pressure and respiratory rate during anesthesia, recovery, and respiratory care in various healthcare settings.

Продукт колдонуу нускамалары

Коопсуздук маалыматы
Абайлаңыз: The Radius PCG should only be operated by qualified personnel or under supervision. Read the manual and all precautionary information before use.

Performance Warnings
Эскертүү: Use the Radius PCG only as described in the manual. It is intended for authorized healthcare professionals only.

Негизги орнотуу жана колдонуу

Батареяларды орнотуу

  1. Unpack and inspect the Radius PCG for external damage. Contact your distributor if damaged.
  2. Press the Battery Cover release button on the Sensor Body to remove the Battery Cover.

Description

General System Description: For a list of compatible EMMA Airway Adapters, visit www.masimo.com.

Өзгөчөлүктөрү

  1. Батарея капкагы
  2. Батарея капкагын чыгаруу баскычы
  3. Lanyard тиркеме
  4. Ойготкучту басуу баскычы
  5. EtCO2 Наркы дисплей
  6. Капнограмма дисплей
  7. Кубат күйгүзүү баскычы
  8. EMMA Airway Adapter connection
  9. Сигнал статусунун көрсөткүчү
  10. Дем алуу ылдамдыгынын көрсөткүчү
  11. Батареянын абалынын көрсөткүчү
  12. Bluetooth көрсөткүчү
  13. Radius PCG Sensor Body

“`

Radius PCGTM

Оператордун колдонмосу

These operating instructions provide the necessary information for proper operation of all models of the Radius PCG. There may be information provided in this manual that is not relevant for your system. General knowledge of capnography and an understanding of the features and functions of Radius PCG are prerequisites for its proper use. Do not operate Radius PCG without completely reading and understanding these instructions. If you encounter any serious incident with product, please notify the competent authority in your country and the manufacturer. Note: Cleared Use Only: The device and related accessories are cleared by the Food and Drug Administration (FDA) and are CE Marked for noninvasive patient monitoring and may not be used for any processes, procedures, experiments, or any other use for which the device is not intended or cleared by the applicable regulatory authorities, or in any manner inconsistent with the directions for use or labeling. Notice: Purchase or possession of this device does not carry any express or implied license to use with replacement parts which would, alone or in combination with this device, fall within the scope of one of the relating patents. CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician. See instructions for use for full prescribing information, including indications, contraindications, warnings and precautions. For professional use. See instructions for use for full prescribing information, including indications, contraindications, warnings, and precautions. Model: EMMA Bluetooth Wireless Radio Contains: FCC ID: VKF-EMMABT | IC: 7362A-EMMABT
Masimo Sweden AB Svärdvägen 15 SE-182 33 Danderyd Sweden Telephone: +46 8 544 98 150 Fax: +46 8 544 98 169 www.masimo.com

MEDICAL ­ GENERAL MEDICAL EQUIPMENT

ЭЛЕКТР ТОГУНУ, ӨРТ ЖАНА МЕХАНИКАЛЫК КОРКУНУЧТУ ГАНА

МЕНЕН ЫЛАЙЫК

ANSI/AAMI ES60601-1: A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012, CSA CAN/CSA-C22.2 NO.

3JSV

60601-1:14

Патенттер: www.masimo.com/patents.htm

®, Masimo®, Radius®, and Root®, are federally registered trademarks of Masimo Corporation.
Radius PCGTM and XTPTM are trademarks of Masimo Corporation. All other trademarks and registered trademarks are property of their respective owners. © 2020 Masimo Corporation

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Мазмуну
Бул колдонмо жөнүндө ---------------------------------------- 5 Продукция Сыпаттоо, өзгөчөлүктөрү, өзгөчөлүктөрү -------------------------- 7 Коопсуздук жөнүндө маалымат, эскертүү жана эскертүүлөр ------------------- -------------------------- 7 бөлүм 1: Технология бүттүview ———————————————————————————— 13 Chapter 2: Description————————————————————————————————- 17 Chapter 3: Basic Setup and Use ———————————————————————————— 19 Chapter 4: Operation ————————————————————————————————- 25 Chapter 5: Alarms and Messages ———————————————————————————– 35 Chapter 6: Troubleshooting —————————————————————————————– 39 Chapter 7: Specifications———————————————————————————————-41 Chapter 8: Service and Maintenance —————————————————————————— 59 Appendix A: Operation with Root———————————————————————————– 69 Appendix B: Concepts of Alarm Response Delay —————————————————————– 99

Бул колдонмо жөнүндө
This manual explains how to set up and use Radius PCGTM. Important safety information relating to general use of Radius PCG appears in this manual. Read and follow any warnings, cautions, and notes presented throughout this manual. The following are explanations of warnings, cautions, and notes. A warning is given when actions may result in a serious outcome (for example, жаракат, олуттуу терс таасир, өлүм) пациентке же колдонуучуга. ЭСКЕРТҮҮ: Бул мурункуampэскертүү билдирүүсү. Оорулуу же колдонуучу бейтапка зыян келтирбөө, бул аппаратка зыян келтирбөө же башка мүлккө зыян келтирбөө үчүн кандайдыр бир өзгөчө кам көрүү керек болгондо эскертүү берилет. ЭСКЕРТҮҮ: Бул мурункуampсак билдирүү. Кошумча жалпы маалымат колдонулса, эскертүү берилет. Эскертүү: Бул мурункуampнота.

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Продукт сүрөттөлүшү, өзгөчөлүктөрү жана максаттуу пайдалануу

Продукт Description

The Radius PCGTM (model: EMMA Bluetooth) is a quantitative mainstream carbon dioxide monitor comprised of a Sensor Body that fits on top of a disposable EMMA Airway Adapter. The Radius PCGTM can connect to other devices using Bluetooth wireless technology.MASIMO-EMMA-Capnograph-Kit-FIG-1
Максаттуу колдонуу
Radius PCGTM measures, displays and monitors carbon dioxide partial pressure and respiratory rate during anesthesia, recovery and respiratory care. It may be used in the operating suite, intensive care unit, patient room, clinic, emergency medicine and emergency transport settings for adult, pediatric and infant patients.
Коопсуздук маалыматы, эскертүүлөр жана эскертүүлөр
CAUTION: Radius PCG is to be operated by, or under the supervision of, qualified personnel only. Read the manual, accessories directions for use, all precautionary information, and specifications before use.
Коопсуздук эскертүүлөрү жана эскертүүлөрү
WARNING: Radius PCG should only be used for the purpose and in the manner described in this manual. WARNING: Radius PCG is intended for use by authorized health care professionals only.

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WARNING: Radius PCG must not be used with flammable anesthetic agents. WARNING: If Radius PCG is used with a respirator or with harmful gases such as N2O, always perform a pre-use tightness check of the patient circuit. WARNING: EMMA Airway Adapters shall not be reused. Reuse of single use Adapters can cause cross infection. WARNING: Do not use the EMMA Adult/Pediatric Airway Adapter with infants as the Adapter adds 6 ml dead space to the patient circuit. WARNING: Do not use the EMMA Infant Airway Adapter with adults/pediatrics as this may cause excessive flow resistance.
Аткаруу эскертүүлөрү жана эскертүүлөр
WARNING: Radius PCG is intended only as an adjunct in patient assessment. It shall be used in conjunction with the assessment of clinical signs and symptoms. WARNING: Use only EMMA Airway Adapters manufactured by Masimo. WARNING: No modification of the Radius PCG probe or the EMMA Airway Adapters is allowed. WARNING: Light transmission can be affected by secretions and moisture pooling on the EMMA Airway Adapter XTPTM windows. When using heated humidifiers special care should be paid to position the Airway Adapter in a vertical position and to change Airway Adapter if necessary. WARNING: Do not use Radius PCG with nebulized medications as this may affect the light transmission of the EMMA Airway Adapter windows. WARNING: Audible alarm of any monitor may not be heard in some loud environments, such as when sirens are in use and the care provider is more distant from the alarm source. Alarm volume should be tested with the extremes of your noise environment to confirm ability or limitations to hear an alarm in all circumstances of the environment. WARNING: Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating properly. WARNING: Make sure that Radius PCG is used in the electromagnetic environment specified in this manual.MASIMO-EMMA-Capnograph-Kit-FIG-2

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WARNING: Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the Radius PCG. Otherwise, degradation of the performance of the Radius PCG could result. Note: Bluetooth functionality is implemented differently by the various connected-device manufacturers and incompatibility between the Radius PCG and your external device may occur. Note: A trained medical professional must determine the proper EMMA Airway Adapter model for each patient application. No hardware or software configuration changes result from the EMMA Airway Adapter model selected. Note: The alarm limits will be reset to default values after Radius PCG powers off.
Тазалоо жана тейлөө эскертүүлөр жана эскертүүлөр
WARNING: Properly use and dispose of batteries or they may leak or explode. WARNING: Lithium batteries may present a fire or chemical burn hazard if mistreated. Do not disassemble, heat above 100°C (212°F) or incinerate. Dispose of used cells promptly. Keep away from children. WARNING: Use only Alkaline batteries or Energizer Ultimate Lithium L92 batteries. Use of other Lithium batteries may present a risk of fire or explosion. WARNING: Replace batteries immediately when the Battery Status Indicator starts blinking. Remaining battery time depends on battery type and other circumstances and cannot be reliably predicted. CAUTION: Remove alkaline batteries when the Radius PCG will not be in use for more than 30 days to avoid damage to the device due to batteries that may leak. CAUTION: Replace both batteries at the same time to avoid mixing fully and partially charged batteries. These actions may cause the batteries to leak; resulting in possible damage to the device. CAUTION: Do not immerse Radius PCG in any liquid. CAUTION: Do not apply excessive pressure on the IR-windows. CAUTION: Never saturate Radius PCG completely with any disinfection solution.

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CAUTION: Only perform maintenance procedures specifically described in the manual; otherwise, return Radius PCG for servicing. Improper maintenance may result in damage to the internal parts. Damage to internal parts may result in no or inaccurate readings. CAUTION: Do not clean Radius PCG with any chemical other than those specified in Maintenance and Cleaning of this manual. These substances may affect the device’s materials and damage internal parts. CAUTION: The Radius PCG and EMMA Airway Adapters are non-sterile devices. Do not submerge Radius PCG or EMMA Airway Adapters in any cleaning solution or attempt to sterilize by autoclave, irradiation, steam, gas, ethylene oxide or any other method. This will seriously damage the device. CAUTION: Do not use undiluted bleach (5% – 5.25% sodium hypochlorite) or any cleaning solution other than those recommended in Maintenance and Cleaning of this manual. Permanent damage to Radius PCG may occur if other unspecified solutions are used. CAUTION: Never submerge Radius PCG in water or any other liquid solution. This may cause permanent damage to the Radius PCG. Note: Before cleaning Radius PCG, remove the batteries and make sure the battery cover is re-attached correctly. Note: The presence of ambient air (0% CO2) in the EMMA Airway Adapter is of crucial importance for a successful Zeroing. Special care should be taken to avoid breathing near the Airway Adapter before or during the Zeroing procedure.
Шайкештик боюнча эскертүүлөр жана эскертүүлөр
WARNING: Any changes or modifications not expressly approved by Masimo shall void the warranty for this equipment and could void the user’s authority to operate the equipment. WARNING: In accordance with international telecommunication requirements, the frequency band of 2.4 GHz and 5.15 to 5.25 GHz is only for indoor usage to reduce potential for harmful interference to co-channel mobile satellite systems. CAUTION: Disposal of Product: Comply with local laws in the disposal of the device and/or its accessories. CAUTION: EMMA Airway Adapters shall be disposed of in accordance with local regulations for bio hazardous waste.MASIMO-EMMA-Capnograph-Kit-FIG-3

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Эскертүү: Бул аппарат FCC эрежелеринин 15-бөлүгүнө ылайык келет. Иштетүү төмөнкү эки шартка ылайык ишке ашат: (1) Бул аппарат зыяндуу тоскоолдуктарды жаратпашы мүмкүн жана (2) бул аппарат келген тоскоолдуктарды, анын ичинде каалабаган иштөөгө алып келиши мүмкүн болгон тоскоолдуктарды кабыл алышы керек. Эскертүү: Бул жабдуу сыналган жана FCC эрежелеринин 15-бөлүгүнө ылайык, В классындагы санариптик аппараттын чектөөлөрүнө ылайыктуу деп табылган. Бул чектөөлөр турак жай орнотулган зыяндуу кийлигишүүлөрдөн акылга сыярлык коргоону камсыз кылуу үчүн иштелип чыккан. Бул жабдуу радио жыштык энергиясын өндүрөт, колдонот жана нурландыра алат жана эгер нускамаларга ылайык орнотулбаса жана колдонулбаса, радио байланыштарына зыяндуу тоскоолдуктарды жаратышы мүмкүн. Бирок, кандайдыр бир орнотууда кийлигишүү болбойт деген кепилдик жок. Эгерде бул жабдуу радио же телевизорду кабыл алууда зыяндуу тоскоолдуктарды жаратса, аны өчүрүү жана күйгүзүү аркылуу аныктоого болот, колдонуучуга төмөнкү чаралардын бири же бир нечеси аркылуу тоскоолдукту оңдоого аракет кылуу сунушталат:
· Кабыл алуучу антеннанын багытын өзгөртүңүз же ордун которуңуз. · Жабдуу менен ресивердин ортосундагы аралыкты көбөйтүү. · Жабдууларды ресивер туташтырылгандан башка чынжырдагы розеткага туташтырыңыз. · Жардам алуу үчүн дилерге же тажрыйбалуу радио/телевидение техникине кайрылыңыз. Эскертүү: Бул жабдуу сыналган жана EN 60601-1-2: 2015, Медициналык түзмөк директивасы 93/42/EEC ылайык медициналык аппараттар үчүн класстын В чектерине ылайыктуу деп табылган. Бул чектөөлөр бардык мекемелерде, анын ичинде үй мекемелеринде зыяндуу кийлигишүүдөн акылга сыярлык коргоону камсыз кылуу үчүн иштелип чыккан. Эскертүү: Бул B классындагы санарип аппараты Канаданын ICES-003 стандартына туура келет. Эскертүү: Бул аппарат Industry Canada лицензиясынан бошотулган RSS стандарттарына туура келет. Иштетүү төмөнкү эки шартка жараша болот: (1) бул аппарат тоскоолдук жаратпашы мүмкүн жана (2) бул аппарат аппараттын каалабаган иштешине алып келиши мүмкүн болгон тоскоолдуктарды кошо алганда, бардык тоскоолдуктарды кабыл алышы керек.

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1-бөлүм: Технология бүттүview
The following chapter contains general descriptions about parameters, measurements, and the technology used in Radius PCG.
Иштөө принциптери
The measurement of CO2 in the breathing gas mixture is based on the fact that different gas components absorb infrared light at specific wavelengths. A beam of invisible infrared light is directed through the respiratory gas flow in the EMMA Airway Adapter. As the beam passes through the Airway Adapter, some of the light is absorbed by the gas mixture. The amount of absorbed light is measured by a miniaturized two-channel spectrometer positioned to receive the infrared light beam. The spectrometer incorporates a filter wheel fitted with two different optical “color” filters. The wavelength ranges of these filters are chosen such that one filters out colors where carbon dioxide has very strong absorption and the other filters out colors where carbon dioxide has no absorption. The spectrometer also incorporates an infrared detector that converts the light beam to an electrical signal. The electrical signal is converted to a digital value that is fed to a microprocessor. The ratio of the light measured through the two filters is then used by the microprocessor to calculate the carbon dioxide concentration in the breathing gas mixture.

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1 Оптикалык чыпкалуу дөңгөлөк жана инфракызыл детектору бар спектрометр 2 Инфракызыл жарык нуру 3 Инфракызыл жарык булагы 4 Дем алуу газы

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EMMA Airway адаптери

Respiratory gas measurements are, as described in the previous section, obtained by continuously measuring the infrared light absorption through the EMMA Airway Adapter. The Airway Adapter is fitted with optical XTPTM windows that are transparent to light in the wavelength ranges of interest. The Airway Adapter may, for example, be inserted between the endotracheal tube and the resuscitation bag or between the resuscitation bag and the patient mask. The Airway Adapter is available in two models: Adult/Pediatric and Infant. Radius PCG operates to specification with either Airway Adapter model when used with its appropriate patient population.
· The Airway Adapters are intended for single patient use. They are disposable and shall not be re-used. Reuse of single patient use Adapters can cause cross infection.
· Airway Adapters shall be disposed of in accordance with local regulations for bio hazardous waste.
EMMA Airway адаптери Чоңдор/Педиатрия (REF 100620) EMMA Airway адаптери ымыркай (REF 100660)MASIMO-EMMA-Capnograph-Kit-FIG-4

1. XTP терезеси (Чоңдор/Педиатрия)

2. XTP терезеси (ымыркай)

Note: A trained medical professional must determine the proper EMMA Airway Adapter model for each patient application. No hardware or software configuration changes result from the Airway Adapter model selected.

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2-глава: Сүрөттөмө
This chapter contains the description of the Radius PCG physical features.
Жалпы системанын сүрөттөлүшү
The Radius PCG system includes the following: · Radius PCG Device · Two (2) AAA Batteries
Туура келген EMMA Airway адаптерлеринин толук тизмеси үчүн www.masimo.com сайтына кириңиз.

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Өзгөчөлүктөрү

1 Батарея капкагы

8 EMMA Airway Adapter

2 Battery Cover release button 9 Alarm Status

3 Lanyard attachment

10 Respiratory Rate Value

4 Alarm Silence button

11 Батареянын абалынын көрсөткүчү

5 EtCO2 Value

12 Bluetooth көрсөткүчү

6 Capnogram

13 Radius PCG Sensor Body

7 Power On button

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3-бөлүм: Негизги орнотуу жана колдонуу
This chapter contains information about setting up Radius PCG before use.
Батареяларды орнотуу
Unpack and inspect the Radius PCG for external damage. Please contact your local distributor in case of damage. 1. Press the Battery Cover release button into the Radius PCG Sensor Body until the Battery Cover pops off.MASIMO-EMMA-Capnograph-Kit-FIG-5

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2. Батарея бөлүкчөсүн ачып, эки (2) AAA батарейканы салыңыз. Батареялар көрсөтүлгөн полярдуулукка ылайык орнотулгандыгын текшериңиз. Батарея орнотулгандан кийин, Батареянын капкагын кайра ордуна коюңуз.

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Аба жолу адаптерин тиркөө
Snap the EMMA Airway Adapter into the Radius PCG Capnograph. It will click into place when properly inserted.

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Түтүккө же маскага туташуу

The Radius PCG can be connected to a patient using an endotracheal tube or mask. The following pictures illustrate these two methods of connection.

Эндотрахеалдык түтүк

Маска

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Күйгүзүү
1. To power on Radius PCG, press the Power On button.

2. When the Radius PCG is ready the EtCO2 Value displays “0” and the Respiratory Rate Value displays dashes “- -“.

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The audible alarm sound may be checked by detaching the Airway Adapter to generate a No Adapter alarm. If the EtCO2 Value is non-zero, ensure that there has not been an accumulation of CO2 between the Radius PCG Sensor Body and the Airway Adapter by removing and reattaching the Airway Adapter. If the EtCO2 Value still displays a non-zero value after this procedure, perform a Zeroing procedure. See Zeroing Procedure on page 61.
Өчүрүү
The Radius PCG switches off automatically during following conditions: · If no breath is detected within 2 minutes from power up. · If no breath is detected for 2 minutes and the alarm has been silenced. · 15 seconds after the Airway Adapter is removed.
Bluetooth орнотуусу
For Radius PCG Basic Bluetooth Setup instructions for connection with devices other than Root, see Bluetooth Operation on page 32. For Radius PCG Bluetooth Setup instructions for connection with Root, see Pairing Radius PCG to Root on page 69.

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4-глава: Операция
The information in this chapter assumes that Radius PCG is set up and ready for use. This chapter provides necessary information for proper operation of the device. Do not operate Radius PCG without completely reading and understanding these instructions.
Radius PCG Display
The Radius PCG is fitted with a graphic OLED-display that displays End-Tidal Carbon Dioxide (EtCO2) and Respiratory Rate (RR) parameters as well as the CO2 waveform (Capnogram).
1 EtCO2 Параметр Наркы 2 Капнограмма 3 RR Параметр Маани

EtCO2
The Radius PCG is available in versions displaying End-Tidal Carbon Dioxide (EtCO2) either in mmHg (0 – 99 mmHg) or kPa (0.0 – 9.9 kPa). EtCO2 values are displayed after one breath and the averaged value is updated every breath.

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Дем алуу ылдамдыгы
Дем алуу ылдамдыгы (RR) мүнөтүнө дем алуу катары көрсөтүлөт (3 – 150 сок/м). RR эки дем алгандан кийин көрсөтүлөт жана маани ар бир дем жаңыланып турат.
Капнограмма
The Capnogram is displayed as a filled graph with a 14.4 sec horizontal sweep and a fixed 0-53 mmHg/0-7 kPa scale. If the CO2 level reaches or exceeds 53 mmHg/7 kPa, a horizontal dashed line (1) will be displayed to indicate that the Capnogram is saturated.

Auto Brightness
To extend battery life time the Radius PCG display has an automatic brightness control which will be activated during stable conditions. Any change in displayed vital parameters, alarm or pressing any button will return the Radius PCG display to normal brightness.

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Батареянын абалынын көрсөткүчү

Батареянын абалынын көрсөткүчү

демейде дисплейдин жогорку оң бурчунда туруктуу жашыл жарык менен күйөт

(Батарея жакшы же начар). Батареялар аз болгондо, Батареянын абалынын көрсөткүчү өчүп баштайт.

Батареянын абалы Батарея Voltage* Battery Status Indicator

OK

>2.4V

Алсыз

2.2Вдан 2.4Вга чейин

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Масимо

Батареянын абалы Батарея Voltage* Battery Status Indicator

Төмөн

<2.2V

* Типтүү баалуулуктар. Батареялардын заряды азайганда ар бир 80 секунд сайын кайталануучу үн сигналы чыгат. Терминал томtagщелочтуу батарейкалар батареялар колдонулбаганда калыбына келет. Калган убакытты болжолдоо электр күйгүзүлгөндөн кийинки биринчи мезгилде ишенимсиз. Дээрлик түгөнүп калган батарейкалар дагы эле көлөмдү бере алатtage above the threshold for battery low indication, even if the internal battery resistance is too high to provide sufficient current to start up the device next time the power on button is activated. To extend battery life time the Radius PCG display has an automatic brightness control, which will be activated during stable conditions. Any change in displayed vital parameters, alarm or pressing any button will return the Radius PCG display to normal brightness.

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Controls
The Radius PCG has one Power On and one Alarm Silence button. These buttons are also be used for adjusting the high and low EtCO2 alarm limits up and down.
1 Күйгүзүү/Төмөн тууралоо баскычы 2 Ойготкучту басуу/Жогоруду тууралоо баскычы

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Параметр орнотуулары
Төмөнкү маалымат демейки сигнал чектерин жана EtCO2 ойготкуч чектөөлөрүн тууралоо үчүн маалыматты камтыйт.
Демейки Ойготкуч чектөөлөрү
RR жана EtCO2 сигналдары үчүн демейки фабрика орнотуулары төмөнкүдөй:

Төмөнкү чек

Жогорку чек

RR (Дем жок) 3 сок/м (20 секунд) NA

EtCO2

ӨЧҮРҮҮ

50 ммHg (7.0 кПа)

EtCO2 Орнотуулар
EtCO2 сигнал чектерин жөндөө диапазондору төмөнкүдөй:

Төмөнкү диапазон

Жогорку диапазон

EtCO2 (ммHg) ӨЧҮРҮҮ; 1 89 mmHg 11 99 mmHg; ӨЧҮРҮҮ

EtCO2 (кПа) ӨЧҮРҮҮ; 0.1 8.9 кПа 1.1 9.9 кПа; ӨЧҮРҮҮ

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Note: The alarm limits will be reset to default values after Radius PCG powers off. If the high EtCO2 limit is decreased close to the low EtCO2 limit, the low limit will be automatically adjusted in order to maintain a minimum difference of 10 mmHg (1.0 kPa) between the high and low alarm limit. Similarly, if the low EtCO2 limit is increased close to the high EtCO2 limit, the high limit will be automatically adjusted to maintain a minimum difference of 10 mmHg (1.0 kPa) between the high and low alarm limit. If no buttons have been activated for a short period during alarm limit adjustment, the Radius PCG will automatically resume normal operation.
Төмөн EtCO2 сигнализациясы
1. Дисплейде “Lo ETCO2 Экраны” жана EtCO2 дисплейинде учурдагы төмөн EtCO2 ойготкуч чеги көрсөтүлмөйүнчө Power On баскычын басып, кармап туруңуз. 29-беттеги Башкарууларды караңыз.
2. Release the Power On button. 3. To adjust the alarm limit: press the Alarm Silence button () to increase, or
the Power On button () to decrease the value. It is possible to switch off the low EtCO2 alarm by adjusting the limit down to 0. The Radius PCG will indicate this setting by showing “- -” on the EtCO2 display during the adjustment routine. If no button has been activated for a short period, the Radius PCG will automatically resume normal operation.

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Жогорку EtCO2 сигнализациясы
1. Дисплейде Hi ETCO2 экраны жана EtCO2 дисплейинде учурдагы жогорку EtCO2 ойготкуч чеги көрсөтүлгөнгө чейин Ойготкучту өчүрүү баскычын басып, кармап туруңуз. 29-беттеги Башкарууларды караңыз.
2. Release the Alarm Silence button. 3. To adjust the alarm limit: press the Alarm Silence button () to increase, or
the Power On button () to decrease the value. It is possible to switch off the high EtCO2 alarm by adjusting the limit above 99 mmHg (9.9 kPa). The Radius PCG will indicate this setting by showing “- -” on the EtCO2 display during the adjustment routine. If no button has been activated for a short period, the Radius PCG will automatically resume normal operation.

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Bluetooth операциясы
The Radius PCG Bluetooth provides a Bluetooth Low Energy (LE) wireless option to allow connection to a compatible smart device or host. Radius PCG Bluetooth can only communicate to a single smart device at a time to minimize the risk of unauthorized access. Bluetooth is disabled by default and must be enabled each time by the user. The unique Bluetooth address contains the product name plus the serial number of the device and will be transmitted to the smart device or host. Confirm the correct connection by controlling that the appropriate serial number is displayed on the smart device or host. If no button has been activated for a short period, the Radius PCG Bluetooth will automatically resume normal operation. If the Bluetooth is enabled, the Bluetooth indicator will appear on the screen. Note: Bluetooth functionality is implemented differently by the various connected-device manufacturers and incompatibility between the Radius PCG and your external device may occur. To enable Bluetooth operation:
1. Press the On button two (2) times to enter Bluetooth mode. See Features on page 18. 2. Press the On button once (1) again to enable Bluetooth. When Bluetooth is enabled, the Bluetooth symbol
(A) and the serial number (B) for the Radius PCG display on the screen as shown. Note: If Radius PCG is off, it must be turned on before Bluetooth can be enabled.

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To disable Bluetooth operation: 1. Press the On button two (2) times to enter Bluetooth mode. 2. Press the On button once (1) again to disable Bluetooth.

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5-глава: Ойготкучтар жана кабарлар
Ойготкучтар жана билдирүүлөр
The Radius PCG is equipped with an Alarm Status Indicator and an audible alarm. The audible alarm can be silenced for 2 minutes by pressing the Alarm Silence button. See Controls on page 29.
· Үн сигналы басылганда, дисплейдин ылдыйкы оң бурчундагы сары жымжырттык сигнал индикатору, б.а. Ойготкучтун абалынын үнсүздүк көрсөткүчү күйөт.
· 2 мүнөттүк үнсүз мезгил ичинде «Ойготкучту басуу» баскычын кайрадан басуу үндүү ойготкучту кайра иштетет.
· If a No Breath alarm is muted by pressing the Alarm Silence button, the Radius PCG will automatically switch off after 2 minutes provided that no new breaths are detected.
· Эгерде сигнализация үнү басылганда өтүп кетсе, сигналдын сөлөкөтү жашыл түскө айланат.
• Ойготкуч жок маалда «Ойготкучту басуу» баскычын басуу да дисплейдин төмөнкү оң бурчунда жашыл үнсүз сигнал индикаторун көрсөтөт.

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Ойготкуч сигналдары

Ойготкуч Дем жок

at t = 0

at t = 20

t = 40, 60, 80, …

Alarm Priority: Low Alarm Priority: Low Alarm Priority: Medium

Төмөн EtCO2 Жогорку EtCO2 бүтөлгөн адаптер 1
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(((·)))

(((·))) (((·))) н/ан/а

(((·))) (((·))) (((·)))

жок

жок

(((·)))

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Сигнал адаптери жок 1

at t = 0

at t = 20

t = 40, 60, 80, …

Alarm Priority: Low Alarm Priority: Low Alarm Priority: Medium

жок

жок

Нөл чекитти тууралоо 1

(((·)))

жок

жок

(((·)))
1 See Chapter 6: Troubleshooting on page 39. Note: t = 0 is defined as the time when the alarm condition first is indicated. t = 40, 60, 80, … shall be interpreted as “40 sec later than t = 0”, “60 sec later than t = 0”, “80 sec later than t = 0” etc. For Low EtCO2 and Hi EtCO2, there is a 20 sec delay before t = 0 when the alarm condition is indicated (i.e. the Alarm Signal Generation Delay is 20 sec).

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Ойготкучтар жана билдирүүлөр
Активдүү сигналдар төмөнкү таблицага ылайык көрсөтүлөт:

Ойготкуч Дем жок

Экран ETCO2 Мааниси RR Наркы НОРМАЛДУУ маани туруктуу 1 “- -” жаркырап 2

Төмөн EtCO2

НОРМАЛДУУ маани күйүп турган нарк туруктуу

Жогорку EtCO2

НОРМАЛДУУ маани күйүп турган нарк туруктуу

Былган адаптер

АДАПТЕР жок

жок

Адаптер жок

АДАПТЕР жок

жок

Нөл чекити тууралоо 3 NORMAL мааниси туруктуу маани туруктуу

Эскертүү 1: EtCO2 мааниси дем жок учурунда убактылуу CO2ди көрсөтөт. Эскертүү 2: Эгерде күйгүзүлгөндө дем такыр жок болсо, RR мааниси туруктуу "- -" көрсөтөт. Эскертүү 3: Нөлдөө процедурасын аткарыңыз. 61-беттеги нөлгө салуу процедурасын караңыз.

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6-бөлүм: Көйгөйлөрдү чечүү
Troubleshooting Radius PCG

Error No Adapter alarm is displayed

Мүмкүн болгон себептер EMMA Airway адаптерин орнотуу керек экенин көрсөтөт.

Сунушталган чечимдер EMMA Airway адаптерин туташтырыңыз. 21-беттеги Аба жолу адаптерин тиркөөнү караңыз.

Clogged Adapter alarm is displayed

Indicates that the EMMA Airway Replace the EMMA Airway Adapter with a new Adapter needs to be replaced with one. a new one.

Zero point adjustment alarm is A zero point adjustment is

көрсөтүлдү

талап кылынат.

Perform a Zeroing procedure. See Zeroing Procedure on page 61.

The unit does not complete the Low battery turn on sequence

Аппарат күйбөйт

· No battery · Low battery

Батареяларды алмаштырыңыз. Батареяларды алмаштырыңыз.

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Ката

Мүмкүн болгон себептер

Сунушталган чечимдер

The measured values of EtCO2 Incorrect zero reference are out of specified accuracy

Нөл коюу процедурасын аткарып, эталондук газ менен өлчөөнү текшериңиз. 59-беттеги 8-бөлүм: Тейлөө жана тейлөөнү караңыз.

Сандар күңүрт көрүнөт

·

·

Measurement does not display ·

on the smart device or host

·

using optional Bluetooth

·

· ·

Automatic brightness control is activated. Exposed to bright lights or sunlight.

Pressing any button will return the Radius PCG display to normal brightness. See Controls on page 29.

Bluetooth is not connected. ·

Smart device, host or

Radius PCG out of range.

Compatible app not

·

installed on smart device.

Smart device damaged.

·

Radius PCG damaged.

·

·

·

Confirm Bluetooth is on for the Radius PCG and the smart device or host. See Bluetooth Operation on page 32. Move the Radius PCG, smart device or host closer to each other. Check that Radius PCG is paired to the correct smart device or host. Confirm a compatible app is installed on the smart device. Close and re-launch the compatible app on the smart device. Contact Masimo Technical Services. See Contacting Masimo on page 65.

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Бөлүм 7: Техникалык шарттар
Radius PCG Specifications Display Range

Өлчөө

Дисплей диапазону

EtCO2 (Соңку толкун CO2) [1], [2] * 0 ммHg дан 99 mmHg га чейин 0 кПадан 9.9 кПага чейин

RR (дем алуу ылдамдыгы)

3 BPM 150 BPM

* ETCO2 дем алуу ылдамдыгы мүнөтүнө 150 битке чейин спецификацияда болот [3]

Тактык (ARMS)

Көмүр кычкыл газы (CO2) [4] Диапазон 0 ммHg дан 99 ммHg 0-40 mmHg ± 2 mmHg, 41-99 mmHg Стандарттык шарттарда көрсөткүчтүн 6%

Диапазону 0 кПадан 9.9 кПага чейин

0-5.3 кПа ± 0.3 кПа, 5.4-9.9 кПа 6% стандарттык шарттарда көрсөткүч

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Дем алуу ылдамдыгы (RR) Диапазону 3-150 сок/м
Электрдик

± 1 bpm

Батарея түрү

Эки (2) AAA клетка батареялары, щелочтуу же литий

Кубаттуулугу – Alkaline [5] Болжол. 4 саат

Кубаттуулугу – Литий L92 [5] Болжол. 8 саат

Экологиялык

Environmental Conditions Operating Temperature

-5 to 50°C (23 to 122°F) -20 to -5°C for 20 minutes [6]

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Environmental Conditions Storage/Transport Temperature

-40…70°C (-40…158°F)

Иштөө нымдуулугу

< 50 hPa H2O (конденсацияланбаган) (41 °Cде 50% RH)

Сактоочу нымдуулук

10 to 95% RH (condensing) at a water vapor partial pressure not exceeding 50 hPa (95 % RH at 32 °C)

Иштеп жаткан атмосфералык басым

60 to 120kPa [1] (i.e. Altitude up to 4000 m)

Атмосфералык басымды сактоо

50дан 120 кПага чейин

Физикалык мүнөздөмөлөрү

Физикалык мүнөздөмөлөрү Өлчөмдөрү 52 мм x 44 мм x 39 мм (2.1″ x 1.8″ x 1.6″)

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Физикалык мүнөздөмөлөрү

Салмагы

Болжол менен 65 г (2.1 унция) батарейкалар менен

Дисплей түрү 96 x 96 пиксел RGB OLED-дисплей

Ойготкучтар

Аудио ойготкучтун сүрөттөлүшү Дем жок, ETCO2 аз, Жогорку ETCO2, Бүктелген адаптер, Адаптер жок, Нөл чекити тууралоо, Батарея аз

Ойготкучтун мүнөздөмөсү Ойготкучтун көлөмү

Description v 57 дБ(А); 67 дБ(А)

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Шайкештик

Коопсуздук стандарттарын сактоо

EN 60601-1:2006/AMD1:2013

EN ISO 80601-2-55:2018

EN 60601-1-2:2015

EN ISO 5356-1: 2015

EN 60601-1-8:2007, C1:2010, A1:2013 EN ISO 14971:2012

EN 60601-1-12:2015

EN ISO 15223-1: 2016

IEC 60601-1 боюнча жабдуулардын классификациясы

Коргоо түрү

Ички кубат (Батареянын күчү)

Электр шокунан коргоо даражасы

Defibrillation proof BF-Applied Part

Protection against harm from solid IP44, Protection from tools and small wires greater than 1mm in diameter and

and liquid ingress

from water spray from any direction.

Иштөө режими

Үзгүлтүксүз операция

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Масимо

IEC 60601-1 боюнча жабдуулардын классификациясы

Стерилдүүлүк

No part of Radius PCG is sterile

Зымсыз спецификациялар

Байланыш (Bluetooth)

Type

Bluetooth GFSK

Жыштык

2402-2480 МГц

Max Peak Output Power -1 dBm

Антенна чокусу -7 дБ

Recommended Range ~10 feet (~3 meters) line-of-sight

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Radio Compliance Radio Modes Bluetooth LE (v4.0)

АКШ

FCC ID: VKF-EMMABT

FCC бөлүктөрү 15.207 жана 15.247

Канада

IC: 7362A-EMMABT RSS-247

Europe

RED 2014/53/EU ETSI EN 300 328 ETSI EN 301 489-1 ETSI EN 301 489-17

Жапония

Japanese Radio Law, Item 19 of Article 2-1

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Кошумча спецификациялар

Жалпы сүрөттөмө

Спецификациялар Чоңдор, педиатриялык жана ымыркай бейтаптардын негизги СО2 мониторинги үчүн компакттуу, аккумулятордук, сандык капнограф.

Measurements [1]

The CO2 partial pressure is measured based on a 2 channel NDIR type gas analyzer at 4­ 5 m with data acquisition rate at 10 kHz (sampылдамдыгы 20 Гц / канал).

Моделдер

CO2 кПа же ммHg менен көрсөтүлөт

Drift of measurement Accuracy

Дрейф жок

Дефибриллятор сыноодон кийин калыбына келтирүү убактысы

Таасирсиз

Эң жогорку беттин температурасы

At Ambient Temperature Surface Temperature

23°C / 73°F

30°C / 86°F

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General 50°C / 122°F

Specifications 57°C / 135°F

Data Output Specifications Breath Detection Adaptive threshold, minimum 1kPa CO2 change.

Adult/Pediatric Dead space 6 ml, Flow resistance < 0,3 cm H2O (@ 30 LPM)

Ымыркай

Dead space 1 ml, Flow resistance < 1,3 cm H2O (@ 10 LPM)

Газ анализаторунун жылытуусу -40°С температурада сакталгандан кийин жылытуу убактысы

Specifications In operation and full accuracy within 15 seconds. A warm up period of 15 minutes is required before Radius PCG is ready for use after being stored with batteries mounted at -40°C when the ambient temperature is 20°C.

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Gas Analyzer Cool-down time after storage at 70°C

Specifications In operation and full accuracy within 15 seconds.

Калибрлөө

No routine calibration is required.

Total System Response < 0.7 seconds Time

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Жетекчилик жана Өндүрүүчүнүн Декларациясы-Электромагниттик эмиссия
Radius PCG is expected to be used in a professional environment like intensive care unit, patient room and operating suite except near high frequency electro surgical equipment and magnetic resonance imaging (MRI) systems. Radius PCG is also intended to be used in emergency medical services as road ambulances. Radius PCG is intended for use in the electromagnetic environment specified below. Customers or end users of Radius PCG should assure that the Radius PCG Bluetooth is used within the intended environment.

Жетекчилик жана Өндүрүүчүнүн Декларациялары – Электромагниттик эмиссиялар

Эмиссияны сыноо

Шайкештик

Электромагниттик чөйрө – көрсөтмө

РФ Чыгышы CISPR 11

1-топ

Radius PCG uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

РФ Чыгышы CISPR 11

Б классы

Бардык кесиптик мекемеде жана үйдөгү саламаттыкты сактоодо колдонууга ылайыктуу

EUROCAE ED-14G же RTCA DO чөйрөлөрү.

160G, Section 21, category M Suitable for use in air ambulances only if Bluetooth is disabled.

деңгээл

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Жетекчилик жана Өндүрүүчүнүн Декларациясы-Электромагниттик Иммунитет
This section constitutes the guidance and Masimo’s declaration regarding electromagnetic immunity for Radius PCG. Essential performance of Radius PCG is gas measurement accuracy (see Citation [4]) including gas reading alarm conditions, or generation of technical alarm conditions, when exposed to the following immunity levels.

Көрсөтмө жана Өндүрүүчүнүн Декларациясы – Электромагниттик Иммунитет

Иммунитет тести

Шайкештик деңгээли

Электромагниттик чөйрө – көрсөтмө

Электростатикалык разряд (ESD) IEC 61000-4-2

+/-8 кВ контакт +/-2 кВ, +/-4 кВ, +/-8 кВ, +/-15 кВ аба

Полдор жыгач, бетон же керамикалык плитка болушу керек. пол синтетикалык материал менен капталган болсо, салыштырмалуу нымдуулук 30% кем эмес болушу керек.

Кубат жыштыгы (50/60 Гц) магнит талаасы. IEC 61000-4-8

30 A/m

Кубаттуу жыштыктагы магниттик талаалар типтүү оорукана чөйрөсүндөгү типтүү жайгашкан жерине мүнөздүү деңгээлде болушу керек.

Нурланган RF IEC 61000-4-3

10 В/м

Портативдик жана мобилдик RF байланыш жабдуулары болушу керек

80%AM@1kHz

used no closer than 30 cm to any part of Radius PCG. Otherwise,

80 MHz to 2.7 GHz and degradation of the performance of this equipment could result.

Table 9 (60601-1-2:2015)

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WARNING: Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating properly. WARNING: Make sure that Radius PCG is used in the electromagnetic environment specified in this manual. WARNING: Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the Radius PCG. Otherwise, degradation of the performance of the Radius PCG could result.
Сунушталган бөлүү аралыктары

Recommended separation distances between portable and mobile RF communications equipment and the Radius PCG The Radius PCG is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Radius PCG gas analyzer can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Radius PCG gas analyzer as recommended below, according to the maximum output power of the communications equipment.

Өткөргүчтүн номиналдык максималдуу чыгуу кубаттуулугу [Вт]

Separation distance according to frequency of transmitter [m] 80 MHz to 2.7 GHz

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Recommended separation distances between portable and mobile RF communications equipment and the Radius PCG

0,01

0.06

0,1

0.19

1

0.6

10

1.9

100

6

Жогоруда саналбаган максималдуу чыгуу кубаттуулугу менен эсептелген өткөргүчтөр үчүн сунуш кылынган бөлүү аралыгы d метр (м) менен өткөргүчтүн жыштыгына тиешелүү теңдеменин жардамы менен бааланышы мүмкүн, мында P – өткөргүчтүн өндүрүүчүсү боюнча ватт (Вт) менен өткөргүчтүн максималдуу чыгуу кубаттуулугу. Эскертүү: Бул көрсөтмөлөр бардык учурларда колдонулбашы мүмкүн. Электромагниттик таралууга структуралардан, объекттерден жана адамдардан сиңирүү жана чагылуу таасир этет.

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Символдор
The following symbols are found on the Radius PCG, or packaging and are defined below.

Symbols Definition

Symbols Definition

Колдонуу боюнча нускамаларды аткарыңыз

Defibrillation Proof Type BF

Каталогдун номери (модель номери) Лот коду Датасы боюнча колдонуу ЖЖЖЖ-АА-КК

Serial number Manufacturer Date of Manufacture YYYY-MM-DD

Сактоо нымдуулугун чектөө

Сактоо температурасы диапазону

Атмосфералык басымды чектөө

Кайра колдонбоңуз

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Символдор

Definition Mark of Conformity to European medical device directive 93/42/EEC

Символдор

Definition Separate collection for electrical and electronic equipment (WEEE)

Bluetooth
Protection from tools and small wires greater IP44 than 1mm in diameter and from water spray
from any direction. Identifies unit has been registered as a radio device

UL LLC сертификаты
3JSV
Эскертүү: Федералдык мыйзам бул аппаратты лицензиясы бар дарыгер же анын буйругу менен сатууну чектейт.
Иондошпогон электромагниттик нурлануу

Федералдык байланыш комиссиясы (FCC) лицензиялоо

Инструкциялар/Колдонуу багыттары/Колдонуу куралдары электрондук форматта жеткиликтүү @http://www.Masimo.com/TechDocs Эскертүү: eIFU бардык өлкөлөрдө жеткиликтүү эмес.

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Цитата

[1] The Radius PCG displays CO2 in partial pressure units (kPa or mmHg) and compensates the displayed value for the
actual barometric pressure. The EtCO2 value is the max partial CO2 pressure measured within a breath and the displayed value is:

акыркы EtCO2 баалуулуктары, башкача айтканда, EtCO2 25% же

EtCO2 <25% берилген 30s ичинде ченелген төрт EtCO2 маанисине чейинки орточо.

[2] Иш жүзүндө жарым-жартылай дем алуучу газды көрсөткөн газ көрсөткүчү сууга каныккан

учурдагы нымдуулук деңгээлинде басым. дене температурасындагы буу (BTPS),

Pisarttyipailcparlleyss6u%reloowf eCrOt2hiannththeeaclvoerorelis,pwohnedrientghe

Бардык суу буусу (ATPD) жок кийин CO2 жарым-жартылай басымы.

[230]1E.1tC0O1.2

болгон

measured measured

at I/E EtCO2

ratio 1:1 using was within the

breath simulator according to the test setup accuracy range for all respiration rates up to

in EN ISO 150 bpm.

80601-2-55

сүрөт.

[4] To include quantitative effect on gas reading from variations in environment conditions (outside STP,

электромагниттик бузулуулар) жана галотандын, этанолдун, изопропил спиртинин, He болушунун тактык диапазону ±4 ммHg/ ±0.5 кПа же ±10% га чейин жогорулатылат.

Acetone and Methane, the is the greater. In addition,

CO2 the

CO2 көрсөткүчтөрүнө төмөнкү интерференция таасирлери бар:

· 60 vol% of N2O typically increases CO2-readings by 10%

· 6fr0omvo2l%1%oOf O2 2astydpeicfaaulllyt)decreases CO2-readings by 4% (Radius PCG compensates CO2-values for influence

· 5 vol% of ENF, ISO, SEV typically increases CO2-readings by 8%

· 15 vol% of DES typically increases CO2-readings by 12%

· 80% Xe typically decreases CO2-readings by 10%

· 50% He typically decreases CO2-readings by 6%.

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[5] Battery life test was performed using Energizer brand batteries. www.energizer.com.
[6] Depending on battery type and status; 19 minutes when tested with new Alkaline batteries, >20 minutes when tested with new Lithium batteries.

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8-глава: Тейлөө жана тейлөө
Кийинки бөлүмдө тазалоо, батареянын иштеши, иштешин текшерүү, тейлөө, оңдоо жана кепилдик жөнүндө маалымат камтылган.
Тазалоо
Radius PCG Cleaning
CAUTION: Do not immerse Radius PCG in any liquid. CAUTION: Do not apply excessive pressure on the IR-windows. Note: Before cleaning Radius PCG, remove the batteries and make sure the battery cover is re-attached correctly. To clean Radius PCG, follow the instructions below:
1. Аба жолу адаптерин алып салыңыз. 2. Сырткы беттердин ар бирин эки жолу же беттерде көрүнгөн калдыктар калгыча сүртүңүз.
төмөнкү эритмелер: · 70% изопропил спирти менен нымдалган чүпүрөк · төртүнчү аммоний хлоридинин эритмеси (мис. үчүн)ample CaviWipesTM) Note: Pay particular attention to crevices and hard to reach areas of the device. Use a soft bristled brush to gently remove any visible residue from crevices as necessary. 3. Repeat the above cleaning step using a fresh cloth or wipe. 4. Allow the Radius PCG device to dry thoroughly before using again.

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The surfaces of Radius PCG have been tested to be chemically resistant to the following disinfectants/solutions: · 70% Isopropyl alcohol · 70% Ethyl alcohol · Quaternary ammonium chloride solution wipe · Cidex Plus (3.4% glutaraldehyde) · 0.5% Sodium hypochlorite (1:10 Bleach to water solution) · Accelerated hydrogen peroxide
Always wipe off residues of disinfection solutions with a wet cloth after exposure. CAUTION: Never saturate Radius PCG completely with any disinfection solution.
Airway Adapter Cleaning
· The EMMA Airway Adapters are not intended to be cleaned. · The Airway Adapters are intended for single patient use. They are disposable and shall not be re-used.
Reuse of single patient use Adapters can cause cross infection. · Airway Adapters shall be disposed of in accordance with local regulations for bio hazardous waste.

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Техникалык тейлөө
Батареяны алмаштыруу
ЭСКЕРТҮҮ: Литий батарейкаларына туура эмес мамиле жасалганда өрт же химиялык күйүп кетүү коркунучу бар. Бөлүп салбаңыз, 100°C (212°F) жогору ысытыңыз же өрттөбөңүз. Колдонулган клетканы тез арада жок кылыңыз. Балдардан алыс болуңуз. ЭСКЕРТҮҮ: Alkaline батарейкаларын же Energizer Ultimate Lithium L92 батарейкаларын гана колдонуңуз. Башка литий батарейкаларды колдонуу өрт же жарылуу коркунучун жаратышы мүмкүн. Батареяларды алмаштыруу үчүн:
1. Чыгаруу баскычын басып, батарея отсегин ачыңыз. 19-беттеги Батареяларды орнотууну караңыз. 2. Түгөнгөн батарейкаларды акырын чыгарып алыңыз. 3. Батарея бөлүкчөсүнө эки жаңы AAA типтеги батарейканы салыңыз. Батареялар орнотулганын текшериңиз
according to the polarity marking. 4. When the batteries are properly fitted, gently snap the battery cover back into place. Note: Always carry spare batteries in the Radius PCG pouch.
Нөлдөө процедурасы
Zeroing is recommended after 500 hours of operation or whenever an offset in gas readings is discovered. Zeroing of the Radius PCG is performed by the following procedure: Note: The presence of ambient air (0% CO2) in the EMMA Airway Adapter is of crucial importance for a successful Zeroing. Special care should be taken to avoid breathing near the Airway Adapter before or during the Zeroing procedure.

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1. Start the Radius PCG by pressing the Power On button. See Controls on page 29.
2. Make sure that a new Airway Adapter is properly fitted. See Attaching Airway Adapter on page 21.
3. Кызмат экранында Кызмат коду "C0" жана Кызмат мааниси "10" чыкканга чейин Күйгүзүү жана Ойготкучту өчүрүү баскычын бир убакта басып, басып туруңуз. Кызматтын мааниси “төмөн санап” баштаганда, б.а. “9” – “8” – “7” ж.б. көрсөтүүдө “0” чыкканга чейин эки баскычты тең басып туруңуз.
4. When the Service value “0” is shown, zeroing of the Radius PCG is
толук.*

1 Кызматтын мааниси 2 Кызмат коду

* The Radius PCG will return to normal measuring mode when the Service value has reached “0” or if any of the buttons are released.

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Газ аралыгын текшерүү

The Radius PCG does not require any routine calibration. A gas span check is recommended at regular intervals to make sure the measurement is within accuracy levels. The suggested interval for gas span check is once every year. The following items are required to perform a gas span check of Radius PCG: Attach the flow regulator to the calibration gas cylinder. Ensure that the valve is shut off completely.

1. Attach a new Airway Adapter to the Radius PCG.
2. Turn on the Radius PCG and ensure that the EtCO2 reading is zero. Otherwise, conduct a Zeroing procedure according to chapter 7.4 above before proceeding.
3. Insert the 15M connector into one end of the Airway Adapter, and connect a second Airway Adapter to the other end (see picture).
4. Turn on the regulator flow. 5. After 30 seconds, record the EtCO2 reading. 6. Turn off the flow. 7. Determine and record an estimated
ambient atmospheric pressure in mmHg. 8. Use the following table to determine if the
unit is reading within specified limits.

1 A gas flow regulator with a plastic tube and a 15M connector 2 Calibration gas (5% CO2, 21% O2, Balance N2) 3 Two (2) Airway Adapters

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Barometric pressure Radius PCG EtCO2 readings should be between [mmHg]

5% CO2 [мм.рт.б.]

5% CO2 [кПа]

660-679

31-36

4,1-4,8

680-699

32-37

4,3-4,9

700-719

33-38

4,4-5,1

720-739

34-39

4,5-5,2

740-759

35-40

4,6-5,4

760-779

36-41

4,8-5,5

780-799

37-42

4,9-5,6

If the unit is reading within the above range then your Radius PCG has been successfully verified. If the unit is not reading within the above range, disconnect the Airway Adapter from the gas cylinder, and perform a Zeroing procedure and then repeat the Gas span check procedure. See Zeroing Procedure on page 61. If verification still fails, contact your local distributor for further instructions.

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Тейлөө жана кайтаруу тартиби
Продукцияны колдоо үчүн Масимо менен байланышыңыз. Зарыл болсо, RMA оңдоо же алмаштыруу үчүн берилет. Масимо менен байланышууга болот 800-326-4890. Америка Кошмо Штаттарынын тышкаркы кардарлар үчүн жергиликтүү байланыш маалыматын тапса болот http://service.masimo.com. Тейлөө жана Тазалоо нускамаларына ылайык, булганган/булганган жабдууларды кайтаруу алдында тазалаңыз. таңгактоо алдында жабдуулар толугу менен кургак экенин текшерип. Мүмкүн болсо, аппаратты оригиналдуу жөнөтүү кутусуна таңгактап, төмөнкү маалыматтарды жана нерселерди тиркеңиз:
· Include the RMA form provided, or a letter describing in detail any difficulties experienced with Radius PCG. Include the RMA number in the letter.
· Кепилдик маалыматы, эсеп-фактуранын көчүрмөсү же башка тиешелүү документтер камтылышы керек. Эгер аппарат кепилдикке кирбесе, оңдоону жабуу үчүн, же эгерде ал болсо, көзөмөлдөө максатында Сатып алуу буйругунун номерин алыңыз.
· Жеткирүү жана эсепке алуу маалыматы. Оңдоо боюнча бардык суроолор боюнча байланыша турган адам (аты-жөнү, телефон/Телекс/факс номери жана өлкө).
· Аппараттын кан аркылуу жугуучу козгогучтарга зыянсыздандырылгандыгы тууралуу сертификат. · Аспапты Масимого төмөнкү 65-беттеги Масимо менен байланышууда көрсөтүлгөн дарекке кайтарыңыз.
Масимо менен байланышуу
Masimo Corporation 52 Discovery Irvine, California 92618 Тел:+1 949 297 7000 Факс:+1 949 297 7001

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Чектелген Кепилдик

Masimo warrants to the original end-user purchaser the Masimo-branded hardware product Radius PCG and any software media contained in the original packaging against defects in material and workmanship when used in accordance with Masimo’s user manuals, technical specifications, and other Masimo published guidelines for a period of 12 months from the original date the Product was obtained by the end-user purchaser. Masimo’s sole obligation under this warranty is the repair or replacement, at its option, of any defective Product or software media that is covered under the warranty. To request a replacement under warranty, Purchaser must contact Masimo and obtain a returned goods authorization number so that Masimo can track the Product. If Masimo determines that a Product must be replaced under warranty, it will be replaced and the cost of shipment covered. All other shipping costs must be paid by purchaser.

Четтетүү

Кепилдик Masimo фирмалык эмес өнүмгө же кандайдыр бир программалык камсыздоого, атүгүл Продукт менен таңгакталган болсо да, же болбосо: (a) сатып алуучуга берилгенде жаңы эмес же анын баштапкы таңгагында болгон эмес; (б) Масимонун жазуу жүзүндөгү уруксатысыз өзгөртүлгөн; (c) Продукттан тышкаркы жабдыктар, түзүлүштөр же системалар; (г) Масимо тарабынан ыйгарым укук берилген адамдан башка бирөө тарабынан демонтаждалган, кайра чогултулган же оңдолгон; (e) башка өнүмдөр менен колдонулат, мисалы, жаңы сенсорлор, кайра иштетилген сенсорлор же башка аксессуарлар, Масимо тарабынан Продукт менен колдонууга арналбаган; (f) эксплуататордун нускамасында же анын маркировкасында каралгандай колдонулбаган же сакталбаган; (ж) кайра иштетилген, рекондицияланган же кайра иштетилген; жана (h) кокустук, кыянаттык менен пайдалануу, туура эмес пайдалануу, суюктуктун тийүү, өрт, жер титирөө же башка тышкы себептерден улам бузулган. Масимо же анын ыйгарым укуктуу дистрибьютору төлөнбөгөн Сатып алуучуга берилген Товарга эч кандай кепилдик колдонулбайт; жана бул өнүмдөр IS-IS-кепилдиксиз берилет.

Кепилдиктин чектөөсү

Except as otherwise required by law or altered by the purchase agreement, the above warranty is the exclusive warranty that applies to the Product and software media, and Masimo does not make any other promises, conditions, or warranties regarding the Product. No other warranty applies, express or implied, including without limitation, any implied warranty of merchantability, fitness for a particular purpose, satisfactory quality, or as to the use of reasonable

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skill and care. See the licensing terms for the terms and conditions that apply to and Software accompanying the Product. Additionally, Masimo will not be liable for any incidental, indirect, special, or consequential loss, damage, or expense arising from the use or loss of use of any Products or Software. In no event shall Masimo’s liability arising from any Product or Software (under contract, warranty, tort, strict liability, or otherwise) exceed the amount paid by purchaser for the Product or Software. The above limitations do not preclude any liability that cannot legally be disclaimed by contract.
Акыркы колдонуучунун лицензиялык келишими
Бул документ сиз (“сатып алуучу”) менен Masimo Corporation (“Masimo”) ортосунда ушул Өнүмдү (“Продукт”) сатып алуу жана камтылган же камтылган Программага (“Программалык камсыздоо”) лицензияны сатып алуу боюнча мыйзамдуу келишим болуп саналат. бул Продуктту сатып алуу үчүн өзүнчө келишимде макулдашылган болсо, төмөнкү шарттар бул Продуктту сатып алууга байланыштуу тараптардын ортосундагы бүтүндөй келишим болуп саналат. Эгерде сиз бул келишимдин шарттарына макул болбосоңуз, бүтүндөй продуктуну, анын ичинде бардык аксессуарларды, алардын оригиналдуу таңгагында, сатуу квитанциясы менен Масимого акчаны толук кайтаруу үчүн тез арада кайтарыңыз.
Чектөөлөр
1. Автордук укуктун чектөөлөрү: Программа жана аны коштогон жазуу материалдары автордук укук менен корголот. Программаны, анын ичинде өзгөртүлгөн, бириктирилген же башка программалык камсыздоо менен камтылган Программаны, же жазуу жүзүндөгү материалдарды уруксатсыз көчүрүүгө ачык тыюу салынат. Сатып алуучу бул Келишимдин шарттарын Сатып алуучунун аткарбагандыгынан келип чыккан же келип чыккан автордук укуктун бузулушу үчүн мыйзамдуу түрдө жоопкерчиликке тартылышы мүмкүн. Бул Лицензияда эч нерсе 17 USC §117 тарабынан берилген укуктардан башка эч кандай укуктарды бербейт.
2. Колдонууга чектөөлөр: Сатып алуучу Продуктту бир жерден экинчи жерге физикалык түрдө өткөрүп бере алат, эгерде Программа көчүрүлбөсө. Сатып алуучу Программаны электрондук түрдө Продукттан башка аспапка өткөрүп бере албайт. Сатып алуучу Программанын же жазуу материалдарынын негизинде алардын көчүрмөлөрүн ача, басып чыгара албайт, которбой, чыгара албайт, тарата албайт, өзгөртүүгө, ыңгайлаштырууга, которууга, тескери инженериялоого, декомпиляциялоого, демонстрациялоого же туунду чыгармаларды түзүүгө укугу жок.
3. Transfer Restrictions: In no event may Purchaser transfer, assign, rent, lease, sell, or otherwise dispose of the Product or the Software on a temporary basis. Purchaser shall not assign or transfer this License, in

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whole or in part, by operation of law or otherwise without Masimo’s prior written consent; except that the Software and all of Purchaser’s rights hereunder shall transfer automatically to any party that legally acquires title to the Product with which this Software is included. Any attempt to assign any rights, duties or obligations arising hereunder other than as set forth in this paragraph shall be void. 4. U.S. Government Rights: If Purchaser is acquiring Software (including the related documentation) on behalf of any part of the United State Government, the following provisions apply: the Software and documentation are deemed to be “commercial software” and “commercial computer software documentation,” respectively pursuant to DFAR Section 227.7202 FAR 12.212, as applicable. Any use, modification, reproduction, release, performance, display or disclosure of the Software (including the related documentation) by the U.S. Government or any of its agencies shall be governed solely by the terms of this Agreement and shall be prohibited except to the extent expressly permitted by the terms of this Agreement.

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Appendix A: Operation with Root

Бүттүview
Radius PCG computes and analyzes End-tidal Carbon Dioxide (EtCO2), Fractional concentration of inspired Carbon Dioxide (FiCO2)* and Respiration Rate (RR) based on the samples gathered from Radius PCG’s breathing circuit, via the airway adapter. The Bluetooth connection allows the Radius PCG parameters to display on Root in the Capnography window. * FiCO2 does not display on the Radius PCG device, FiCO2 only displays on Root.
Орнотуу
Pairing Radius PCG to Root
Upon successful pairing of Radius PCG to Root, capnography measurements collected using the Radius PCG Capnograph display on both devices. On Root, the data is displayed in the Capnography window on the Main Screen of Root. See Capnography Window on page 74. Note: Bluetooth functionality is implemented differently by the various connected-device manufacturers and incompatibility between the Radius PCG and your external device may occur. Note: Radius PCG can be paired to Root while an ISA Sidestream Gas Analyzer is connected to Root through the MOC-9 connection, however, the Unable to handle Capnography channel on Bluetooth message displays, and the Capnography window is populated from the ISA Sidestream Gas Analyzer. See Troubleshooting Radius PCG on page 39. To pair Radius PCG with Root:
1. Press the On Button to turn on Radius PCG. See Features on page 18.

2. On Root, at the bottom right corner of the Main Screen, press the Main Menu icon .

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3. Select the Device Settings menu icon. 4. Select the Bluetooth menu icon.
Note: If Bluetooth is Off, turn it On, select OK and wait for the Masimo device MAC address to appear before proceeding to the next step. 5. On the Bluetooth screen, select the EMMA Pair button. The Pair EMMA screen displays. 6. On Radius PCG, press the On button two (2) times to enter Bluetooth mode. 7. Press the On button once (1) again to enable Bluetooth. When Bluetooth is enabled, the Bluetooth symbol and the serial number for the Radius PCG display on the screen. See Bluetooth Operation on page 32. Note: If Radius PCG is off, it must be turned on before Bluetooth can be enabled. 8. Place Radius PCG close to Root. Radius PCG should appear under the Devices Found list on the Root screen. Note: The number displayed is the serial number of the Radius PCG device. See About on page 89 for additional information. This can provide assistance if multiple Radius PCG devices are within range of the Masimo device when pairing and displayed under the Devices Found list.

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9. Press/select the desired Radius PCG under the Devices Found list, and then press/select the Pair button.

10. After pressing/selecting the Pair button, Root returns to the Bluetooth screen. · The MAC address for Radius PCG displays on the screen.

· The Info screen icon Screen on page 90.

displays next to the MAC address. See Accessing the Radius PCG Info

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Confirm Correct Radius PCG Connection
To confirm the correct Radius PCG is paired to Root, verify that the Radius PCG serial number displayed on the About screen matches the serial number displayed on the Radius PCG screen when Bluetooth is enabled. See About on page 89.

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Reestablishing Radius PCG Connection with Root
Radius PCG may become disconnected from the Masimo device for a number of reasons, which may include: · Moving out of Bluetooth range · Powering off from non-use · Bluetooth connection is turned off on the Masimo device
To reestablish communication with the Masimo device, cycle the Radius PCG Bluetooth Off and back On. 1. Press the Radius PCG On button two (2) times to enter Bluetooth mode. 2. Press the Radius PCG On button once (1) again to disable Bluetooth. 3. Press the Radius PCG On button once (1) again to enable Bluetooth.
The Masimo device and Radius PCG communication should resume. If a communication issue continues, forget Radius PCG on the Masimo device (disconnect) and pair again. See Disconnecting Radius PCG from the Masimo Device on page 91.

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Операция
Capnography Window
Parameters and measurements display in the Capnography window. Capnography parameters display by default as numeric values and as a graphical representation. When multiple technologies are connected to the Masimo device, each technology’s parameters are displayed in an individual window. On Root, the relative size of each window can be configured using the Layout feature, which is accessible though the Layout icon in the Main Menu. For additional information, see the Operator’s Manual, Root® or Operator’s Manual, Root® with noninvasive blood pressure and temperature. The image below is an example of the Root Radius PCG Capnography window.

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Ref. Feature

1

Capnograph Display See Capnograph Display on page 76.

Trend 2 See Chapter 3: Operation in the Operator’s Manual, Root® or Operator’s Manual, Root® with noninvasive
blood pressure and temperature.

Well 3 See Chapter 3: Operation in the Operator’s Manual, Root® or Operator’s Manual, Root® with noninvasive
blood pressure and temperature.

4

EtCO2 Display See Parameter Settings on page 78.

5

FiCO2 Display* See Parameter Settings on page 78.

6

RR Display See Parameter Settings on page 78.

7

Toggle Waveform On/Off See Capnograph Display on page 76.

* FiCO2 does not display on the Radius PCG device. FiCO2 only displays on Root as a placeholder and parameter values are not displayed.

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Capnograph Display

The capnograph display is a waveform representation of a patient’s CO2 levels throughout inhalation and exhalation. Waveforms Values are represented by a waveform that ranges from 0 to 60 mmHg (additional units of measure available: kPa, vol%). When a CO2 waveform is not available, a straight line is displayed. View/Hide Waveform

To toggle the waveform on or off, touch the capnograph icon display.

at the right end of the individual parameter

Негизги меню параметрлерине кирүү
To access the Main Menu options: At the bottom right corner of the touchscreen, press/select the Main Menu icon.

With Radius PCG connected to the Masimo device, the Main Menu options change and are reflected below.

Layout See Chapter 3: Operation of the Operator’s Manual, Root®.

Device Settings See Device Settings on page 88.

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Capnography See Capnography Settings on page 77.
Capnography Settings

About See About on page 89.

The Capnography menu allows the user to view and customize settings for Capnography on Root ONLY. Capnography setting changes made on the Masimo device are NOT transferred to the Radius PCG device. Changes to Capnography settings for the Radius PCG device are made on the device itself (and are NOT transfered to the Masimo device). See Chapter 4: Operation on page 25 for information about settings for the Radius PCG device. The following Capnography settings options are available:

Parameter Settings See Capnography Settings on page 77.

Additional Settings See Additional Settings on page 87.

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Параметр орнотуулары

From the Capnography screen, touch Parameter Settings, and then change individual parameter settings/alarms by selecting one of the following parameters:

End-tidal Carbon Dioxide See End-tidal Carbon Dioxide (EtCO2) on page 78.

Respiratory Rate See RR Settings on page 83.

Inspired Carbon Dioxide*

* FiCO2 does not display on the Radius PCG device, FiCO2 only displays

See Inspired Carbon Dioxide (FiCO2) on the Masimo device.

81-бетте.

End-tidal Carbon Dioxide (EtCO2)
From the End-Tidal Carbon Dioxide Settings screen, access the following screens: EtCO2 Alarms on page 79 About Parameter Information on page 85 Trends on page 86

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EtCO2 Alarms
From the End-Tidal Carbon Dioxide screen, touch Alarms, and then change any of the following options: WARNING: Alarm limits on the Radius PCG device and the Masimo device are set independently of each other. If alarm limits are not set the same, the Masimo device may not alarm at the same time as the Radius PCG device. See Chapter 4: Operation on page 25 for information on adjusting alarm limits on the Radius PCG device.

Options* Description

Жогорку чек

Жогорку чек - ойготкучту пайда кылган жогорку босого.

Ойготкуч приоритети

Заводдун демейки жөндөөлөрү

Колдонуучу конфигурациялоочу орнотуулар

Орто

7.9 vol% 7.9 kPa 60 mmHg

0.2 to 24.9 vol% in steps of 0.1, or Off 0.2 to 29.9 kPa in steps of 0.1, or Off 2 to 224 mmHg in steps of 1, or Off When set to Off, alarm is disabled

1.6 том%

Төмөн чек

Low Limit is the lower threshold that triggers an alarm.

Medium 1.6 kPa

12 мм рт.ст

Off, or 0.1 to 24.8 vol% in steps of 0.1 Off, or 0.1 to 29.8 kPa in steps of 0.1 Off, or 1 to 223 mmHg in steps of 1 When set to Off, alarm is disabled

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Options* Description High Upper area of the display Caution range that provides a Range caution indicator.

Alarm Priority NA

Factory Default Settings Off

Колдонуучу конфигурациялоочу орнотуулар
Off, or 0.1 to 2.5 vol% in steps of 0.1 Off, or 0.1 to 3.2 kPa in steps of 0.1 Off, or 1 to 24 mmHg in steps of 1

Төмөн

Lower area of the display

Caution range that provides a

NA

Өчүк

range caution indicator.

Off, or 0.1 to 2.5 vol% in steps of 0.1 Off, or 0.1 to 3.2 kPa in steps of 0.1 Off, or 1 to 24 mmHg in steps of 1

Silence Sets the amount of time Duration that the alarm is silenced.

NA

2 мүнөт

30 seconds, 1, 2, or 5 minutes

Ойготкуч кечигүү

When an alarm condition is met, this feature delays the NA audible part of an alarm.

30 секунд

0, 5, 10, 15, 20, 30, or 60 seconds

* Capnography setting changes made on the Masimo device are not transferred to the Radius PCG device. Changes to Capnography settings for the Radius PCG device are made on the device itself. See Chapter 4: Operation on page 25 for information about settings for the Radius PCG device.

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Inspired Carbon Dioxide (FiCO2)

From the Inspired Carbon Dioxide Settings screen, access the following screens: FiCO2 Alarms on page 81 About Parameter Information on page 85 Trends on page 86
FiCO2 Alarms
From the Inspired Carbon Dioxide screen, touch Alarms, and then change any of the following options: WARNING: Alarm limits on the Radius PCG device and the Masimo device are set independently of each other. If alarm limits are not set the same, the Masimo device may not alarm at the same time as the Radius PCG device. See Chapter 4: Operation on page 25 for information on adjusting alarm limits on the Radius PCG device. Note: At this time, FiCO2 is not displayed on Radius PCG or the Masimo device. The following information only discusses the settings on the Masimo device, however, FiCO2 parameters DO NOT display.

Options* Description

Жогорку чек

Жогорку чек - ойготкучту пайда кылган жогорку босого.

Ойготкуч приоритети

Заводдун демейки жөндөөлөрү

Колдонуучу конфигурациялоочу орнотуулар

Орто

0.8 vol% 0.8 kPa 6 mmHg

0.2 to 24.9 vol% in steps of 0.1, or Off 0.2 to 29.9 kPa in steps of 0.1, or Off 2-224 mmHg in steps of 1, or Off When set to Off, alarm is disabled

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Options* Description

Төмөн чек

Low Limit is the lower threshold that triggers an alarm.

Alarm Priority Low

Заводдун демейки жөндөөлөрү

Колдонуучу конфигурациялоочу орнотуулар

Off, or 0.1 to 24.8 vol% in steps of 0.1 Off, or 0.1 to 29.8 kPa in steps of 0.1 Off Off, or 1-223 mmHg in steps of 1 When set to Off, alarm is disabled

High Upper area of the display

Caution range that provides a

NA

Өчүк

Range caution indicator.

Off, or 0.1 to 2.5 vol% in steps of 0.1 Off, or 0.1 to 3.2 kPa in steps of 0.1 Off, or 1 to 24 mmHg in steps of 1

Төмөн

Lower area of the display

Caution range that provides a

NA

Өчүк

Range caution indicator.

Off, or 0.1 to 2.5 vol% in steps of 0.1 Off, or 0.1 to 3.2 kPa in steps of 0.1 Off, or 1 to 24 mmHg in steps of 1

Silence Sets the amount of time Duration that the alarm is silenced.

NA

2 мүнөт

30 seconds, 1, 2, or 5 minutes

Ойготкуч кечигүү

When an alarm condition is met, this feature delays the NA audible part of an alarm.

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30 секунд 82

0, 5, 10, 15, 20, 30, or 60 seconds Masimo

* Capnography setting changes made on the Masimo device are not transferred to the Radius PCG device. Changes to Capnography settings for the Radius PCG device are made on the device itself. See Chapter 4: Operation on page 25 for information about settings for the Radius PCG device.

RR Settings
From the Respiratory Rate Settings screen, access the following screens: RR Alarms on page 83 About Parameter Information on page 85 Trends on page 86
RR Alarms
From the Respiratory Rate screen, touch Alarms, and then change any of the following options: WARNING: Alarm limits on the Radius PCG device and the Masimo device are set independently of each other. If alarm limits are not set the same, the Masimo device may not alarm at the same time as the Radius PCG device. See Chapter 4: Operation on page 25 for information on adjusting alarm limits on the Radius PCG device.

Options* Description

Жогорку чек

Жогорку чек - ойготкучту пайда кылган жогорку босого.

Alarm Priority High

Заводдун демейки жөндөөлөрү

Колдонуучу конфигурациялоочу орнотуулар

2-149 in steps of 1, or Off 50
When set to Off, alarm is disabled

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Options* Description

Төмөн чек

Low Limit is the lower threshold that triggers an alarm.

Alarm Priority High

Заводдун демейки жөндөөлөрү

Колдонуучу конфигурациялоочу орнотуулар

Off, or 1-148 in steps of 1 6
When set to Off, alarm is disabled

High Area of the display range

Caution that provides a caution

NA

Өчүк

Range indicator.

Off, or 1 to 15 in steps of 1 When set to Off, alarm is disabled

Төмөн

Area of the display range

Caution that provides a caution

NA

Өчүк

Range indicator.

Off, or 1 to 15 in steps of 1 When set to Off, alarm is disabled

Silence Sets the amount of time Duration that the alarm is silenced.

NA

2 мүнөт

30 seconds, 1, 2, or 5 minutes

Ойготкуч кечигүү

When an alarm condition is met, this feature delays the NA audible part of an alarm.

30 секунд

0, 5, 10, 15, 20, 30, or 60 seconds

* Capnography setting changes made on the Masimo device are not transferred to the Radius PCG device. Changes to Capnography settings for the Radius PCG device are made on the device itself. See Chapter 4: Operation on page 25 for information about settings for the Radius PCG device.

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About Parameter Information
Additional information about each parameter is available. To access additional information about parameters:
1. From the Parameter Settings screen, touch the About icon. The following is an example for EtCO2.
2. An About screen appears for the selected parameter and displays information about the parameter.

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Тренддер
From any of the capnography parameter setting screens, touch Trends, and then change any of the following options:

Options Description

Заводдун демейки жөндөөлөрү

Y огу Макс

EtCO2, FiCO2

The Trend Max is the highest value displayed.

8.0 том%

8.0 кПа

60 мм рт.ст

Колдонуучу конфигурациялоочу орнотуулар
0.1 to 25.0 vol% in steps of 0.1 0.1 to 30.0 kPa in steps of 0.1 1 to 225 mmHg in steps of 1

RR

35

Y огу Мин

EtCO2, FiCO2

The Trend Max is the highest value displayed.

0.0 том%

0.0 кПа

0 мм рт.ст

1дөн 150га чейин 1 кадам менен
0.0 to 24.9 vol% in steps of 0.1 0.0 to 29.9 kPa in steps of 0.1 0 to 224 mmHg in steps of 1

RR

0

0дөн 149га чейин 1 кадам менен

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Кошумча орнотуулар
Use the Additional Settings screen to configure the following:

Options* Apnea Timeout**

Description

Factory Default Settings User Configurable Settings

Displays the set no-breath timeout 20 seconds

NA

Set O2 Range**

Displays the set O2 range

0-30 vol%

NA

Set N2O Range** Displays the set N2O Range

0-30 vol%

NA

CO2 Unit of Measure Sets the CO2 display unit

мм рт.ст

mmHg, kPa***, or vol%

* Capnography setting changes made on the Masimo device are not transferred to the Radius PCG device. Changes to Capnography settings for the Radius PCG device are made on the device itself. See Chapter 4: Operation on page 25 for information about settings for the Radius PCG device. ** These fields are read-only and cannot be configured by the user. *** Selecting kPa will cause all stored Trend data to be erased.

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Түзмөктүн жөндөөлөрү

The Device Settings menu allows the user to view and customize settings for the Masimo device. The Device Settings options are:
Bluetooth See Bluetooth on page 88.

Bluetooth
Use the Bluetooth screen to enable or disable Bluetooth connectivity, connect devices to the Masimo device using a Bluetooth connection or view connected device information. For complete information on the Masimo device Bluetooth menu, see the Operator’s Manual for the Masimo device.

Option Description

Factory Default Setting Configurable Settings

Bluetooth Enables or disables Bluetooth connectivity. Off

Күйүк же Өчүк

EMMA Pairs Radius PCG to Root.

NA

Pair, Info*

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* After paring, the Radius PCG Info screen can be accessed through the Bluetooth screen. See the Accessing the Radius PCG Info Screen on page 90.
Жөнүндө
Listed under Capnography, use the About screen to view information for the Radius PCG device. These details may be helpful during troubleshooting.

нерсе*

Description

Serial number Displays the Radius PCG serial number.**

HW Version Displays the Radius PCG hardware version number.**

SW Version Displays the Radius PCG software version number.**

MAC address Displays the Radius PCG Bluetooth MAC address.

Signal Strength Displays the Radius PCG Bluetooth received signal strength indicator (RSSI).**
* These fields are read-only and cannot be configured by the user. ** Displays when Radius PCG is turned on and connected to the Masimo device.

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Accessing the Radius PCG Info Screen
The following information is for viewing the Radius PCG Info screen. Radius PCG information as well as disconnecting (un-pairing) from the Masimo device are available on this screen. To access the Radius PCG Info screen:
1. On the Masimo device, touch the Bluetooth icon on the main screen, or navigate to the Bluetooth screen. See Device Settings on page 88.
2. Next to Radius PCG, touch the information icon . The Radius PCG Info screen displays.

Radius PCG Info
The Radius PCG Info screen displays the following information for Radius PCG:

Item* HW Version

Description Displays the Radius PCG hardware version number.**

SW Version Displays the Radius PCG software version number.**

MAC address Displays the Radius PCG Bluetooth MAC address.

Signal Strength Displays the Radius PCG Bluetooth received signal strength indicator (RSSI).**

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нерсе*

Description

Унутуу

Press/select to disconnect the Bluetooth connection between Radius PCG and the Masimo device. See Disconnecting Radius PCG from the Masimo Device on page 91.

* These fields are read-only and cannot be configured by the user. ** Displays when Radius PCG is turned on and connected to the Masimo device.

Disconnecting Radius PCG from the Masimo Device
To disconnect Radius PCG from the Masimo device, perform the following: 1. Access the Radius PCG Info Screen. See Accessing the Radius PCG Info Screen on page 90. 2. Press/select the Forget button. 3. On the Forget Device pop-up window, press/select the Forget button to confirm. Note: Press/select the Cancel button to leave Radius PCG paired to the Masimo device.

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Root Messages
The following section lists common Radius PCG related messages that may appear on the Masimo device, their potential causes, and next steps.

Alarm/Exception Activation Messages

Alarm Next Steps Priority

Дем табылган жок

Indicates no breath is detected within

Жогорку

selected apnea timeout setting.

Replace Adapter · Indicates that an adapter is clogged or High blocked, not allowing flow.
· Indicates that the adapter should be replaced.

· Confirm patient is properly connected to Radius PCG.
· Replace the adapter or sampлиния линиясы.
Check for a blockage and replace the adapter if necessary.

Адаптер жок

Adapter disconnected/not detected

High Connect an adapter to Radius PCG

Low EtCO2 SIQ Low FiCO2 SIQ
Zeroing Required

Indicates low signal confidence in the measurement displayed. A zero point adjustment is required.

NA

Ensure patient is properly connected

to Radius PCG.

High Perform the zeroing procedure. See Zeroing Procedure on page 61.

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Alarm/Exception Messages Capnography Disconnected
Unable to handle Capnography channel on Bluetooth

Activation · Radius PCG is out of Bluetooth range. · Radius PCG has turned off.
Radius PCG is paired to Root and a capnography device is connected to Root through the MOC-9 connection. The Capnography window is populated from the MOC-9 capnography device.*

Alarm Next Steps Priority High · Ensure Radius PCG is within
Bluetooth range during operation. · Turn Radius PCG on.
High Only one (1) capnography device can be connected to Root at one time. Disconnect one of the capnography devices.

Unable to handle Capnography channel on MOC-9 port X (1-3)

A capnography device is connected to Root through the MOC-9 connection and Radius PCG is paired to Root. The Capnography window is populated from the Radius PCG.

Жогорку

Only one (1) capnography device can be connected to Root at one time. Disconnect one of the capnography devices.

* Radius PCG does not reconnect automatically after disconnecting the capnography device from the MOC-9 connection. Radius PCG must be disconnected and paired again to communicate with Root and display its data on the Main Screen.

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Troubleshooting Radius PCG with Root

Симптом

Мүмкүн себеп

Түзөтүү

Root Bluetooth settings do ·

not display the ability to pair Radius PCG.

·

Root software requires updating. · Root model is not compatible · with Radius PCG

Update software to latest version. Newer Root model is required to use with Radius PCG.

Cannot pair Radius PCG to · Masimo device.
·
·

Masimo device Bluetooth may be · off.

Radius PCG may be out of

·

Bluetooth range with the

Masimo device.

·

Ички ийгиликсиздик.

Ensure Bluetooth on the Masimo device is turned on. Ensure Radius PCG is within range of the Masimo device when pairing. Radius PCG requires service. See Service and Return Procedure on page 65.

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Root Specifications Display Range

Measurement EtCO2 (End-Tidal CO2)

Display Range* 0% to 25%

0 кПадан 32.5 кПага чейин

0 мм рт.б.дан 244 мм рт.б.га чейин

FiCO2 (Fractional Concentration of Inspired CO2)** 0% to 25%

0 кПадан 32.5 кПага чейин

0 мм рт.б.дан 244 мм рт.б.га чейин

RR (дем алуу ылдамдыгы)

0 BPM 150 BPM

* The display ranges in this table represent the display ranges on Root and do not represent the display ranges for Radius PCG. For Radius PCG specifications, see Radius PCG Specifications on page 41. ** FiCO2 does not display on the Radius PCG device, FiCO2 only displays on Root. Parameter values are not displayed.

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Резолюция

Parameter Resolution

EtCO2

0.1%

0.1 кПа

1 мм рт.ст

FiCO2* 0.1%

0.1 кПа

1 мм рт.ст

RR

1 BPM

* This parameter does not display on Radius PCG.

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Толкун формасынын масштабы
The following table contains Capnogram waveform display ranges.

Measurement Waveform Scale

EtCO2

0дөн 8кө чейин %

0дан 8 кПага чейин

0дан 60 мм.рт.б

Bluetooth иштөө диапазону

Bluetooth Operational Range Maximum distance from Masimo Device Approx. 32 feet (10 meters)

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Appendix B: Concepts of Alarm Response Delay
Concepts of Alarm Response Delay
As with any monitoring equipment, the audible and visual alarms are subject to alarm response delay, which is composed of Alarm Condition Delay and Alarm Signal Generation Delay. Alarm Condition Delay is the time from the occurrence of the triggering event to when the alarm system determines the alarm condition exists. While Alarm Signal Generation Delay is the time from the onset of an alarm condition to the generation of its alarm signal. The graphic below is a simplified illustration of the concept of alarm response delay and does not reflect actual lengths of delays.

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Ref Definition

Ref Definition

1 Instantaneous signal from the patient 3 Displayed Value

Ref Definition t Time

2 Alarm Limit

4 Alarm Signal Generation — —

· The Alarm Condition Delay is graphically represented as t2 ­ t1 in the figure above to show the delay due to processing and averaging.
· The Alarm Signal Generation Delay is graphically represented as t3 ­ t2 in the figure above to show the delay due to alarm system strategy and communication time.
· The overall alarm system delay time is graphically represented as t3 ­ t1.

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300617/LAB-10347E-0720

Документтер / Ресурстар

MASIMO EMMA Capnograph Kit [pdf] Instruction Manual
EMMA Bluetooth, EMMA Capnograph Kit, EMMA, Capnograph Kit

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