Newtech USB1, NT1D Usr manual

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NT1D Vital Signs Monitor

Operating Manual

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Preface

This operation manual introduces the monitor’s performance, way of operation and others safety

information and so on. This is the best start for new user to use the monitor. This manual is intended

for readers who are family with contacting various measurement and who have experience in

operating monitoring equipment.

Monitor’s features:

 Combines a capnograph and pulse oximeter in a small, portable, lightweight monitor.  Measures and displays SpO  Measures and displays pulse rate one digital displays.  Measures and displays EtCO  Measures and displays respiration rate one digital displays.  Displays CO  Employs audible and visual alarm warnings for monitored parameters and instrument

malfunctions.

 Displays current trend line and trend table.  Displays table of alarm events.  Stores history data.  Provides user selectable language options: English and Chinese.  Uses internal batteries pack to supply power.  Provides external power supply.  Transfers history data wireless.  Equips with wireless USB adapter and PC software.

The monitor is intended for monitoring adult, pediatric, and neonatal patients in clinical environments

where healthcare is provided by healthcare professionals, i.e. doctors, nurse, or technicians.

and SpO2 waveforms and trends in one interface

2 in one graphic and one digital displays.

z This manual includes the maximal configuration. The monitor you use may have not some

functions.

z Federal Law in the United States restricts this device to sale, distribution and use by or on the

order of a physician.

Symbols

The following symbols appear on the monitor:

Symbols Description

Complies with the European Medical Device

Manufacturer date

Attention! Consult the accompanying

document (This manual)）

BF Type Defibrillation

Directive 93/42/EEC

Disposal requirement

Manufacturer

Serial number

Static sensitivity mark!

IPX1

RX ONLY

Prescriptive device, operated by qualified

Drip proof

personnel only!

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CONTACT

Address: R1-B1, Hi-Tech Park, NanShan District,

Shenzhen, Guangdong 518057

P.R. China

Postcode: 518057

Tel: 86-755-26525910

Fax: 86-755-26525912

Web cite: Http://www.sznewtech.com

E-mail: sales@sznewtech.com

Authorised Representative

Name: Shanghai International Holding Corp. GmbH（Europe）

Address: Eiffestrasse 80, 20537 Hamburg Germany

Tel: 0049 – 40 – 2513175

FAX: 0049 – 40 – 255726

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Contents

Table of Contents

1.Safety........................................................................................................................................ 1-1

1.1 Safety Information ............................................................................................................................ 1-1

1.2 Product Label .................................................................................................................................... 1-3

2.Introduction .............................................................................................................................. 2-1

2.1 Product Introduction............................... .......................................................................................... 2-1

2.2 Monitor Features .......................................................................................................................... .... 2-1

2.3 Basic Principles of Operation......................................................................................................... 2-1

2.4 Terms’ Explanations ......................................................................................................................... 2-2

3. Unpacking and Installation ...................................................................................................3-1

3.1 Unpacking.......................................................................................................................................... 3-1

3.2 Installing Pedestal ............................................................................................................................3-3

3.3 Installing AC adapter........................................................................................................................ 3-3

3.4 Installing Wireless USB Dongle..................................................................................................... 3-3

3.5 Sensor Connections ........................................................................................................................ 3-4

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4. Initial Setup ............................................................................................................................. 4- 1

4.1 Main Structure................................................................................................................................... 4-1

4.2 Description Crust.................................................. ............................................................................ 4-1

4.3 Basic Operation................................................................................................................................4-2

4.3.1 Keys Operation .......................................................................................................................................4-3

4.3.2 Start Up .................................................................................................................................................... 4-3

4.3.3 Running Mode .........................................................................................................................................4-4

4.3.4 Information Column ................................................................................................................................4-5

4.3.5 Status Bar ................................................................................................................................................ 4-5

4.3.6 Adjust the Volume of Pulse ...................................................................................................................4-6

4.3.7 Indicating Batteries’ Charge and Recharging .....................................................................................4-6

4.3.8 Shut Down ...............................................................................................................................................4-7

4.4 Storage ................................. .............................................................................................................. 4-8

4.5 Environment of Protection.............................................................................................................. 4-8

4.6 Impact of Performance Consideration..................................... ..................................................... 4-8

5. Interface and Function ..........................................................................................................5-1

5.1 Main Monitoring Interface .............................. ................................................................................. 5-1

5.2 Big Chart Mode................................................................................................................................. 5-2

5.3 Real-time Trend Interface ............................................................................................................... 5-2

5.3.1 Trend Graph Interface............................................................................................................................5-2

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5.3.2 Trend Table Interface .......................... ...................................................................................................5-4

5.3.3 Saving Historical Trend.......................................................................................................................... 5-5

5.4 Event Table Interface................................................. ...................................................................... 5-5

5.5 Setting Menu Interface .................................................................................................................... 5-6

5.5.1 Setting Alarm Limits................................................................................................................................5-6

5.5.2 Setting SpO

5.5.3 Setting CO

5.5.4 Setting Patient’s Information .................................................................................................................5-9

5.5.5 Setting Volume........................................................................................................................................5-9

5.5.6 Setting Time and Date ......................................................................................................................... 5-10

5.5.7 Setting Trend ........... ..............................................................................................................................5-10

5.5.8 Data Output ...........................................................................................................................................5-10

5.5.9 Set Module............................................................................................................................................. 5-11

5.5.10 Resume Settings ................................................................................................................................5-11

5.5.11 System Information................................................................ ............................................................. 5-11

............................................................................................................................................5-8

..............................................................................................................................................5-8

5.6 Audible and Visual Indication ....................................................................................................... 5-12

6. Monitoring SpO

..................................................................................................................... 6-1

6.1 Overview ........................................................ .................................................................................... 6-1

6.2 Principles of Measurement ............................................................................................................. 6-1

6.2 Abnormal State of SpO

6.4 Directions for SpO

Measurement: ......................................................... .............................. 6-2

Sensor Use.....................................................................................................6-2

6.5 Measuring Restriction......................................................................................................................6-3

7. Monitoring CO

....................................................................................................................... 7-1

7.1 Overview ........................................................ .................................................................................... 7-1

7.2 Principles of Measurement ............................................................................................................. 7-1

7.3 Medical Use of CO

7.4 CO

Sensor Adapter Zero............................................................................................................... 7-2

Sensor............................................... ............................................................. 7-1

8. Data Output............................................................................................................................. 8-1

8.1 Driver Installations and Copy of Data Analysis Software................................................ .......... 8-1

8.1.1 Install USB Drivers .................................................................................................................................8-1

8.1.2 Copy the Folder “History Data Viewer”................................................................................................8-3

8.2 Transmit and Delete Data............................................................................................................... 8-4

9. Accessories............................................................................................................................. 9-1

9.1 Standard Configure of NT1D.......................................................................................................... 9-1

9.2 Optional Accessories of NT1D.......................................................................................................9-1

10. Troubleshooting and Maintenance.................................................................................. 10-1

10.1 Troubleshooting Guide ................................................................................................................ 10-1

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Contents

10.2 Technical Assistance ................................................................................................................... 10-2

10.3 Factory Default Alarm Range Values ................................. ...................................................... 10-2

10.4 Returning the Monitor.................................................................................................................. 10-2

10.5 Maintenance and Cleaning ........................................................................................................ 10-2

10.6 Periodic Safety Checks............................................................................................................... 10-4

10.7 Guarantee.............................................. ........................................................................................10-4

Appendix A: Specifications........................................................................................................A-1

Appendix B: EMC (Electro-Magnetic Compatibility) .............................................................B-1

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Safety

1.Safety

1.1 Safety Information

This chapter lists warnings, attentions, and basic safety information when using NT1D Vital Signs

Monitor. Similar or related and other safety information can be found in appropriate chapters.

Important! To use the monitor correctly and safely, carefully read this operator’s manual. Use of the

monitor requires full understanding and strict observance of these instructions, the precautionary

information in boldface type, and the specifications.

z “Warning”: Indicates a potentially harmful condition that can lead to personal injury.

z “Caution”: Indicates a condition that may lead to equipment damage or malfunction. z “Note”: A point of particular interest or emphasis intended to provide more effective or convenient.

z To protect against electric shock hazard, the monitor’s cover is to be removed only by qualified

service personnel. There are no user-serviceable parts inside.

z The monitor is a prescription device and is to be operated by qualified healthcare personnel only. z The exact time and date of the table of events depends on the precision of time and date what you

have set in the monitor, when alarms happened.

z The monitor is not suitable for use in the presence of flammable anesthetic mixture with air,

oxygen or nitrous oxide. Use of SpO2 and CO2 Sensor in such environment may present an

explosion hazard.

z Sucking the chemic matter came from cracked LCD display will cause poisoning. Please take

yourself carefully when the monitor’s display was broken.

z Please check the patient periodically, insure the monitor runs well and place SpO

sensor rightly.

z CO

readings, respiratory rate, pulse oximetry readings, and pulse signal can be affected by

certain ambient environmental conditions, sensor application errors, and certain patient conditions.

z The use of accessories, transducers, sensors and cables other than those specified may result in

increased emission and/or decreased immunity of the equipment and/or system.

z DO NOT silence the audible alarm if patient safety may be compromised. z Mark sure that the speaker and speaker’s pore are not covered by any slipcover; otherwise the

alarm maybe can not be heard.

z Always respond immediately to a system alarm since the patient may not be monitored during

certain alarm conditions.

z Before each use, verify that the alarm limits are appropriate for the patient being monitored. z To ensure accurate performance and prevent device failure, do not expose the monitor to extreme

moisture, such as rain.

z The SpO

sensor must be moved to a new site at least every 4 hours. Because individual skin

condition affects the ability of the skin to tolerate sensor placement, it may be necessary to change

the sensor site more frequently with some patients. If skin integrity changes, move the sensor to

another site.

z DO NOT use oximetry sensors during magnetic resonance imaging (MRI) scanning. Conducted

current could cause burns. The sensors may affect the MRI image and the MRI unit may affect the

accuracy of oximetry measurements.

z Monitor has no defibrillation synchronization, so it cannot be connected to defibrillation

sensor and CO2

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1-1

Safety

instruments.

z Follow precautions for electrostatic discharge (ESD) and electromagnetic interference (EMI) to

and from other equipment.

z To ensure patient electrical isolation, connect only to other equipment with circuits that are

electrically isolated.

z If uncertain about the accuracy of any measurement, check the patient’s vital signs by alternate

means, and then make sure the monitor is functioning correctly.

z The danger of losing data: this monitor can save current patient’s data only when it is shut down

normally or in low voltage, therefore:

1）when using internal power supply, only allow to shut down the monitor normally or in low

voltage. Do not take batteries down abruptly when the monitor is working or in the progress of

shutting down. To do this can avoid losing data. 2）when using external AC adapter or the pedestal to supply power, if there are four Ni-MH

batteries, you can take batteries down when the monitor is working or in the progress of shutting

down. If there aren’t batteries, you can only pull the adapter out or break the pedestal away only

after monitor shut down normally, you can not pull the adapter out or break the pedestal away

when it is working. To do this can avoid losing data.

z Using SpO

sensor incorrectly may do harm to patient’s skin. Please check whether the SpO2

sensor is placed following the instructional way and position.

z DO NOT use NIBP or other constructing instruments on same appendage as sensor as blood flow

interrupted by NIBP cuff or circulatory patient condition will result in no pulse found or loss of pulse.

z DO NOT alter or modify SpO

and CO2 sensor. Alterations or modifications may affect performance

or accuracy.

z Using the SpO

sensor in the presence of bright lights may result in inaccurate measurements. In

such cases, cover the sensor site with an opaque material.

z DO NOT use SpO

and CO2 sensor if the sensor or the sensor cable appears damaged.

z DO NOT lift the monitor by the SpO2 sensor or CO2 sensor cable as they could disconnect from the

monitor, causing the monitor to fall on the patient.

z To ensure patient safety, do not place the monitor in any position that might cause it to fall on the

patient.

z Carefully route patient cabling (SpO

sensor and CO2 sensor) to reduce the possibility of patient

entanglement or strangulation.

z Be sure to follow local governing ordinances and recycling instructions regarding disposal or

recycling of batteries.

z Reuse, disassembly, cleaning, disinfecting or sterilizing the single patient use CO

airway adapters

may compromise functionality and system performance leading to a user or patient hazard.

Performance is not guaranteed if an item labeled as single patient use is reused.

z If the SpO

and CO2 Sensor fails to respond as described in this user guide; DO NOT use it until

approved for use by qualified personnel.

z The CO

Sensor is not patient isolated. Use of the sensor does not require direct patient contact. If

isolation is desired or required, it is the responsibility of the Host system to provide the necessary

isolation.

z This monitor’s electrical isolation part is centralized in the AC adapter. When using external power

supply or charging the batteries, please use only the medical grade AC adapter provided by the

manufacturer. If in doubt about the integrity of the mains supply connection, operate the monitor

from its internal battery pack.

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Safety

z The monitor is intended only as an adjunct in patient assessment. It must be used in conjunction

with clinical signs and symptoms.

z Please do not repeat to use one-off accessories. z Do not use SpO2 and CO2 sensor across between epidemical and unepidemical patients before

sterilized.

z Do not connect the host monitor, sensor, AC adapter and pedestal to any other equipment

mutually.

z All equipment connected to the monitor must conform to EN60601-1. z Use only approved sensors, pulse oximetry and CO2 cables. Other sensors or oximetry cables

may cause improper monitor performance.

z Changes and modifications not expressly approved by the manufacturer responsible for

compliance could void the user’s authority to operate the equipment.

z Ambient light, movement, electromagnetic interference, artifacts, dysfunctional hemoglobin, and

certain dyes, etc may be interfere in the pulse oximeter's function.

z Do not sterilize by irradiation steam, or ethylene oxide.

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1.2 Product Label

Figure1-1: Product label

1-3

Safety

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1-4

Introduction

2.Introduction

2.1 Product Introduction

NT1D is a portable handheld vital signs monitor that continuously monitors end tidal carbon

dioxide (EtCO

for monitoring only and must be used in the continuous presence of a qualified healthcare provider,

and transfer history data to PC through USB adapter. It is intended for use in any environment where

continuous, noninvasive monitoring of these parameters is desired, including hospital and hospital

type facilities. The monitor is intended for use on adult, pediatric, and neonatal patients.

Our product is composed of host monitor,

USB adapter and PC software.

Our product has input and output ports:

Input: SpO

Output: Sends data to USB adapter wirelessly.

Using the monitor in excessive movement will affect the accuracy of saturation measurements

2.2 Monitor Features

), respiratory rate (RR), oxygen saturation (SpO2), and pulse rate. The unit is indicated

SpO2 sensor, mainstream CO2 sensor, pedestal, wireless

sensor port, CO2 sensor port;

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z Combines a capnograph and pulse oximeter in a small, portable, lightweight monitor. z Measures and displays SpO

2 in one graphic and one digital display.

z Measures and displays pulse rate one digital displays. z Measures and displays EtCO

2 in one graphic and one digital display.

z Measures and displays respiration rate one digital displays. z Displays CO

and SpO2 waveforms and trends in one interface

z Employs audible and visual alarm warnings for monitored parameters and instrument

malfunctions.

z Displays current trend line and trend table. z Displays table of alarm events. z Stores history data. z Provides user selectable language options: English and Chinese. z Uses internal batteries pack to supply power. z Provides external power supply. z Transfers history data wireless. z Equips with wireless USB adapter and PC software.

2.3 Basic Principles of Operation

z SpO

principles of operation

Pulse oximetry is based on two principles: 1) oxyhemoglobin and deoxyhemoglobin, which differ in

their absorption of red and infrared light (spectrophotometry), and 2) changes in the volume of arterial

blood in tissue during the pulse cycle (plethysmography), and hence, light absorption by that blood.

A pulse oximeter determines SpO

by passing red and infrared light into an arteriolar bed and

2-1

Introduction

measures changes in light absorption during the pulsatile cycle. Red and infrared low power

lightemitting diodes (LEDs) in the oximetry sensor serve as light sources; a photodiode serves as the

photodetector.

Because oxyhemoglobin and deoxyhemoglobin differ in light absorption, the amount of red and

infrared light absorbed by blood is related to hemoglobin oxygen saturation. To identify the oxygen

saturation of arterial hemoglobin, the monitor uses the pulsatile nature of arterial flow.

During systole, a new pulse of arterial blood enters the vascular bed and blood volume and light

absorption increase. During diastole, blood volume and light absorption reach their lowest point.

The monitor bases its SpO

measurements on the difference between maximum and minimum

absorption (measurements at systole and diastole). The focus of light absorption by pulsatile arterial

blood eliminates the effects of nonpulsatile absorbers such as tissue, bone, and venous blood.

z CO

principles of operation

The CO

Sensor is used for the continuous measurement of CO2 and respiratory rate. The sensor

measures CO2 by using the infrared absorption technique. The principle is based on the fact that CO2

molecules absorb infrared (IR) light energy of specific wavelengths, with the amount of energy

absorbed being directly related to the CO

sample containing CO

, the electronic signal from the photo detector (which measures the remaining

concentration. When an IR beam is passed through a gas

light energy) is measured. This signal is then compared to the energy of the IR source and adjusted to

accurately reflect CO

concentration of CO

concentration in the sample. The CO2 Sensor’s response to a known

is stored at the factory in the sensor’s memory. A reference channel accounts for

optical changes in the sensor, allowing the system to remain in calibration without user intervention.

z Host monitor’s principles of operation

Patient’s signal is checked and magnified through various sensors and then transported to

parameter module to disposal data by extended cable, and then communicate with host monitor’s

control board to show the measuring result. The results will be shown on the screen in the form of

waveform and figure. It can save every parameter for 99 patients, 72 hours per capita, and can

transfer data to PC wirelessly.

z Pulse oximetry readings and pulse signal can be affected by certain ambient environmental

conditions, probe application errors, and certain patient conditions.

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Specific information about ambient environmental conditions, probe application, and patient conditions, is contained throughout this manual.

2.4 Terms’ Explanations

SpO

Oxygen saturation value PR Pulse Rate

Pleth Blood dimension EtCO2 End tidal carbon dioxide value

RR Respiration rate

2-2

Unpacking and Installation

3. Unpacking and Installation

3.1 Unpacking

Open the package according to the marks on the box. Carefully remove the monitor and its

accessories.

Count the accessories according to the packing list.

z Check the monitor and accessories for any physical damage.

If there are any problems, contact the distributor immediately.

Friendly reminder: The packaging material should be saved for future transportation and storage.

z Customers should put the wrappers somewhere that child couldn’t touch. When disposaling the

wrappers, you should follow local governing ordinances or hospital instructions.

z The equipment may be polluted by microorganism when deposit and transportation. Please check

the packaging before using. Do not use it if it is damaged.

This monitor is equipped with Ni-MH rechargeable Batteries as well as alkaline batteries. When

using Ni-MH Batteries, we can use external AC adapter or the pedestal to charge to the host monitor.

But when using alkaline batteries, we can not use external AC adapter or the pedestal to charge to the

host monitor.

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z Never operate the device without the battery cover in place. z This monitor only sustain “AA” size Ni-MH Batteries and alkaline batteries，do not use any type of

batteries that have no admission.

z when using alkaline batteries，do not use external AC adapter or the pedestal to charge to the host

monitor.

z DO NOT use Ni-MH Batteries and alkaline batteries together！

z Ni-MH

Batteries’ handling

• Do not immerse the battery pack in water; it may malfunction.

• Only recharge the battery pack in the monitor, provided by your local representative, to avoid

possible overheating, burning or rupture of the battery pack.

z Ni-MH

Batteries’ storage

• Short-term storage (one month or less): The battery pack has an automatic discharge feature.

You must periodically check the charge level of the battery pack.

• Long-term storage (6 months or more): The battery pack must be stored in a cool, dry area. Its

charge decreases over time. To restore the battery pack to full power, charge and discharge it

three times before use. Long-term storage, without charging the battery, may degrade the battery

capacity.

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3-1

Unpacking and Installation

z Ni-MH Batteries’ disposal

• Do not dispose of the battery pack in fire; it may explode.

• Be sure to follow local governing ordinances and recycling instructions regarding disposal or

recycling of batteries.

z The monitor is not suitable for use in the presence of flammable anesthetic mixture with air,

oxygen or nitrous oxide.

z When z To ensure patient electrical isolation, connect only to appointed AC adapter with circuits that are

z To ensure patient safety, do not place the monitor in any position that might cause it to fall on the

z If the batteries happen to leak liquid, break the external safeguard or run out of charge, please

z Carefully route cables to reduce the possibility of patient entanglement or strangulation z To ensure accurate performance and prevent device failure, do not expose the monitor to extreme

z DO NOT use Ni-MH batteries and alkaline batteries together. When exchanging batteries, you

z Please use accompanying batteries only!

z Check the batteries periodically for corrosion. Replace batteries if corrosion is present, otherwise

z Insert the (-) terminal of each battery first, compressing the battery terminal spring until the (+)

z To remove the batteries, reverse the installation process, removing the positive end of each battery

z To avoid corrosion of the contacts, remove batteries from the battery compartment, if you do not

using alkaline batteries, do not charge them.

electrically isolated. Do not use unauthorized AC adapter.

patient.

stop using these batteries and follow local governing ordinances and recycling instructions

regarding disposal or recycling of batteries.

moisture, such as rain.

should replace all depleted batteries by fresh ones.

damage to the monitor may occur.

terminal clears the positive spring, and pressing the battery downward into place.

first.

intend to use the monitor for an extended period of time.

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3-2

Unpacking and Installation

3.2 Installing Pedestal

Figure: 3-1 Install pedestal

1. Plug the AC adapter into the faucet of the pedestal, as shown in Figure 3-1.

2. Put the monitor into the pedestal following the right orientation to insure the contact of metal point

and shrapnel.

3. Connect AC adapter to electrical outlet.

4. If the monitor is shut down, it will set up and display the charging interface, pressing the On/Off key

will enter into normal operating mode.

5. If the monitor is working, it will display the movement of battery icon.

z Do not plug the monitor into the pedestal at wrong orientation. z Make sure equip the monitor with Ni-MH batteries, do not charge alkaline batteries or any other

type of batteries. Do not mix different kinds of batteries to use!

z When there are no batteries in the monitor and use the pedestal to supply power, you have danger

of losing data. So please make sure shut the monitor down before taking the pedestal away.

3.3 Installing AC adapter

1. Plug the AC adapter into the chargeable faucet which on the bottom of the host monitor.

2. Connect AC adapter to electrical outlet.

3. If the monitor is shut down, it will set up and display the charging interface, pressing the On/Off

key will enter into working interface.

4. If the monitor is working, it will display the movement of battery icon.

3.4 Installing Wireless USB Dongle

This equipment has been tested and found to comply with the limits for a class B digital device,

pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection

against harmful interference in a residential installation. This equipment generates uses and can

radiate radio frequency energy and, if not installed and used in accordance with the instructions, may

cause harmful interference to radio communications. However, there is no guarantee that interference

will not occur in a particular installation. If this equipment dose cause harmful interference to radio or

television reception, which can be determined by turning the equipment off and on, the user is

encouraged to try to correct the interference by one or more of the following measures:

1. Reorient or relocate the main device.

3-3

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Unpacking and Installation

2. Increase the separation between the equipment and receiver.

3. Consult the dealer or an experienced technician for help.

Figure 3-2: Install wireless USB Dongle

Installing steps:

1. Install driver and software at PC.

2. Plug wireless USB Dongle into PC’s USB faucet, The USB Dongle receive data from monitor via

wireless, as shown in Figure 3-2.

3. Open the monitor in 2 meters around the PC, the monitor will send

the data to USB Dongle via

wireless.

4. Press MENU key, enter into “sending data” dialog.

5. Choose “connect” button to open the ward software.

6. The software will show historical data of patient’s ID which have stored in the host monitor at the

side column, if it’s connected successfully.

z In order to insure the quality of the transporting signal, please let the monitor close to the USB

wireless adapter plugged in PC as possible and make sure there is no barrier between them.

z This monitor complies with Part 15 of the FCC Rules. Operation is subject to the following two

conditions:

(1) This device may not cause harmful interference.

(2) This device must accept any interference received, including interference that may cause

undesired operation.

z The monitor used for this transmitter must be installed with providing a separation distance of at

least 20cm from all persons.

3.5 Sensor Connections

z Before use, carefully read the sensor directions for use, including all warnings, cautions, and

instructions.

z Do not use a damaged sensor. z Do not immerse or wet the sensor. z Do not use a sensor with exposed electronic components.

z Use only sensors and its cable suited to this monitor for SpO

and CO2 measurements. Other

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1.71 字符, 列表制表位 + 不在 2 字符

3-4

Unpacking and Installation

sensors may cause the monitor improper performance.

z Do not lift the monitor by the sensor cable because the cable could disconnect from the monitor,

causing the monitor to drop on the patient.

Figure 3-3: Installing sensors

z Installing SpO2 sensor

1. Select the appropriate sensor for the patient.

2. Refer to Figure 3-3, Connect the oximeter plug to pulse oximeter convex interface.

3. The probe is finger of tip oximeter probe. Attach the finger probe with the light to the patient. Be

sure to fully insert the patient's finger into the probe.

4. Apply the sensor following the instructions supplied with the sensor.

Installing CO2 sensor

1. Insert the CO2 Sensor connector into the receptacle of the host monitor. To remove the connector,

grasp the body portion of the connector back and remove.

2. Shown below is the CO

Sensor connection to a CO2 adapter

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Figure 3-4: Installing CO2 sensor

3. Open the function of measuring CO

Note: Do not remove by pulling cable.

. Please see chapter 5 for more information.

3-5

Unpacking and Installation

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3-6

4. Initial Setup

4.1 Main Structure

Initial Setup

The monitor is composed by host monitor, SpO

Sensor, CO2 Sensor and pedestal.

4.2 Description Crust

Figure 4-1 through 4-4 show the crust, display, pedestal and rear/top view of the monitor.

Figure 4-1: Crust

The function of each numbered label in Figure 4-1 is described below:

Label Description Function

SpO

Connector Connect the host monitor and SpO2 Sensor

Connector Connect the host monitor and CO2 Sensor

Power indicator light Indicate the state of host monitor

Display Window Display the user’s interface

Keys Operate the host monitor

Crust Protect the internal parts of host monitor

Figure 4-2：Pedestal View

4-1

Initial Setup

Figure 4-3：Rear/top view

The function of each numbered label in Figure 4-3 is described below:

Label Description Function

Speaker Emit sounds of pulse and alarm

Rear shuck Protect the internal parts of host monitor

Battery door Open it can install or unload batteries

Electrical outlet Connect the host monitor and AC adapter

Pedestal connector Connect the host monitor and pedestal

On/Off key

Connector

SpO

Connector

Open and close the host monitor

Connect the host monitor and CO

Connect the host monitor and SpO

Sensor

4.3 Basic Operation

z The monitor is a prescription device and is to be operated by qualified personnel only. z Do not lift the monitor by the probe cable because the cable could disconnect from the monitor,

causing the monitor to drop on the patient.

z Prior to using the monitor, carefully read the manual and accessory directions for use, all

precautionary information in boldface type, and all specifications.

z The monitor is intended only as an adjunct in patient assessment. It must be used in conjunction

with clinical signs and symptoms.

z Before using the monitor, remove the plastic protective sheet that covers the display. This sheet is

only on the display to protect it during shipping. Leaving it on during monitoring could make it

difficult to read displayed measurements.

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1.71 字符, 列表制表位 + 不在 2 字符

4-2

Initial Setup

4.3.1 Keys Operation

Figure 4-4: keys

The function of each numbered label in Figure 4-4 is described below:

Label Description Function

MENU key Press this bottom to enter submenu.

MUTE key Press this bottom to shut down the alarm of this parameter or

restart all alarms.

Up key Move menu and cursor upwards or increase number.

Right key Move menu and cursor rightwards.

Down key Move menu and cursor upwards or decrease number.

OK key Use to choose menu or number.

Left key Move menu and cursor leftwards.

4.3.2 Start Up

z Enclosing butteries

If the monitor is turned off, when you have enclosed batteries, press On/Off key can turn on the

monitor. The start interface is shown in Figure 4-5 below:

Figure4-5: Initialization Screen

z If the battery were insufficient to operated, you maybe can see the opening of the system. And

then, the monitor turns itself off automatically. If the batteries are less or installing the batteries is

4-3

Initial Setup

failure, this monitor may have no response. Then, Please make sure the batteries have enough

energy.

z The monitor is intended only as an adjunct in patient assessment. It must be used in conjunction

with clinical signs and symptoms.

z This monitor is a prescription device and is to be operated by qualified personnel only. z Do not connect anything other than a SpO

sensor to the SpO2 sensor port (for example, do not

attempt to connect a PC to the monitor at the sensor port).

z Do not connect anything other than an CO

sensor to the CO2 sensor port

z Self Test

When turned on, the monitor automatically performs a Self Test. The screen will display the followings

in turn:

1) It will display the software’s version number at all the test times.

2) The self test progress of magnetic disk, power indicator light and speaker is displaying below

the version number.

3) Make sure that you can hear “dee” sound and the power light is on. That means finishing the

self test successfully. If not, do not continue to use this monitor, contact your provider or

manufacturer.

After self testing, if you haven’t set the system time or the right has lost, a dialog box will come out to

hint you set the system time manually.(Refer to Figure 4-6).

Figure 4-6 Setting system time

z Make sure that you can hear “dee” sound and the power light is on. If not, do not continue to use

this monitor.

z Do not lift the monitor by the sensor cable because the cable could disconnect from the monitor,

causing the monitor to drop on the patient.

z Make sure there is no any barrier in the front of the speaker and the speaker’s pores aren’t

covered. Otherwise, you may not hear alarms.

z When adjust any menu’s parameter, the screen will display partially but still record data.

4.3.3 Running Mode

After turning on the monitor, the SpO

testing is opened automatically. Steps are as follows:

4-4

Initial Setup

1) Install the SpO2 sensor correctly and put patient’s finger in it.

2) The monitor will search for pulse in 10 seconds.

3) If pulse search is successful, in %SpO

and PR area will display the patient’s %SpO2 and PR. Pulse

indicator will jump together with the pulse jumping. Speaker will generate "dee dee" with the pulse

jumping. Feature as follows:

z %SpO

: Express percent oxygen saturation

z PR: In pulse beats per minute (bpm)

Steps of opening CO

1) Attach the CO

2) Press MENU key to enter the setting menu, open CO

inserted, but doesn’t input, EtCO

3) If there is CO

will be shown at the EtCO

z EtCO

measuring mode:

sensor to the monitor and adapter correctly.

switch. The SpO2 sensor has already been

and RR display area displays “- - -”.

flowing the flow sensor, patient’s end tidal carbon dioxide value and respiration rate

and RR display area.

means end tidal carbon dioxide value, and has three units:%, KPa, mmHg (default).

z RR means the respiration times of every minute (bpm）.

4.3.4 Information Column

From left to right ,the information column displays: time, the state of alarm and mute, remaindering

full of magnetic disk, patient’s ID and type and batteries’

charge level. As shown in figure 4-7.

Figure 4-7: Information column

The function of partial icons in Figure 4-7 is described below:

Name State Description

State of alarm

It means the general alarm switch is turn on, but one or

more sub-switch maybe have already turn off。

It means the general alarm switch is turn off. At this state,

the monitor can generate any alarms except low voltage

alarming.

State of silence

Hint of recording data

Hint of full memory

It means all alarming sound is turn on.

It means one or more alarming sound is turn off.

It means recording historical data for present patient.

It means full memory for present patient and stopping recording data.

4.3.5 Status Bar

Name State Function

Loss of sensor icon

Loss of finger icon

Search pulse icon

Low signal icon

The SpO

When the monitor is search pulse, the icon will be shown.

It will be displayed when the sensor is off.

sensor has already been inserted, but the sensor

not attached to the finger, the icon will be shown.

It will be displayed if the patient’s signal is low.

4-5

Initial Setup

4.3.6 Adjust the Volume of Pulse

You can adjust the volume of pulse by using the right/left key in all interfaces except trend graph

interfaces.

4.3.7 Indicating Batteries’ Charge and Recharging

z Be sure to follow local governing ordinances and recycling instructions regarding disposal or

recycling of batteries.

z Do not recharge alkaline batteries.

z The system use AA alkaline batteries to estimate remainder time. The icon

appears

when there is only approximately 15 minutes of using time remains. The remainder time will

be different if use other kinds of batteries.

z Check the batteries periodically for corrosion. If don’t use the monitor for three months or

more time, please take all batteries away.

Indicating batteries charge

When the monitor is working, the battery-shaped icon in information column will show remainder

charge. When approximately 15 minutes of charge time remains,

will wink and begin low

battery voltage warning, as shown in figure 4-8.

Figure 4-8: low charge icon

If the voltage is excessive low, the monitor will come out a window to reminder user that the monitor

must be shut down and the progress can not be terminable, as shown in figure 4-9.

Figure 4-9: low voltage warning screen

z Internal Recharge Function

When the monitor is connected to an external power source (even if the monitor is turned off), the

battery pack charges automatically. When charging, the battery-shaped icon displays a dynamic

pattern, press On/Off key to enter double waveform interface. After charging, the battery-shaped icon

will show filling pattern, press On/Off key to enter main monitoring interface. If user pulls the charger

out or breaks the pedestal away when the monitor is closed, it will turn off automatically. The charging

screen is shown in figure 4-10.

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4-6

Initial Setup

Figure 4-10: Charging screen

When the monitor is working, if you connect it to AC adapter or put it on pedestal, the

battery-shaped icon at information column displays a dynamic pattern from 1 to 4 panes. You can

continue using the monitor if user pulls the charger out or breaks the pedestal away in working mode.

4.3.8 Shut Down

1） Shut down normally Press the On/Off key for full gauge to shut down the monitor when it’s working. The monitor will

come out a window, as shown in figure 4-11.

Figure 4-11: Shut down normally

2） Shut down in low voltage

The monitor turns itself off automatically when batteries are depleted.

The system enters into the state of low voltage, when approximately 15 minutes of charge time

remains. The icon

will wink and stored trend data is saved in memory. After that, the historical

data can’t be saved, so please shut it down normally and change batteries.

If the voltage is excessive low, the monitor will come out a window to reminder user that the monitor

must be shut down and the progress can not be terminable, as shown in figure 4-9.

z You can stop shutting the monitor down if it closed automatically because of low voltage. z The low voltage is distinguished by alkaline battery. That is different for Ni-MH battery, but it

doesn’t matter with using the monitor.

z If you press On/Off key when the AC adapter is inserted, the system will enter the state of

dormancy after full gauge.

4-7

Initial Setup

z In order to keep optimal performance of the equipment, please open the monitor at least 30

seconds after being shut down or cut power.

z The historical data can be saved as the battery-shaped icon winking. After that the data won’t be

saved even if shut down the monitor normally.

4.4 Storage

Remove the batteries from the instrument before long-term storage, or if the device won't be used

for 6 months or more. This protects the device from damage due to batteries leaking acid.

Store the device in its original shipping carton and packing materials to help protect the device

from damage during storage.

4.5 Environment of Protection

For minimizing risks, discard the used-up batteries and this monitor according to your local

government organization rules, ROHS（2002/95/EC）and WEEE（2002/96/EC）.

4.6 Impact of Performance Consideration

Inaccurate SpO

Prolonged and/or excessive patient movement;

measurements can be caused by:

z Anaemia; z Venous pulsations; z Intravascular dyes, such as indocyaninegreen or methylene blue; z Significant levels of dysfunctional hemoglobins; z Defibrillation.

The affects of electromagnetic interference on oximetry reading is discussed in the

Troubleshooting and Maintenance section of this manual.

Inaccurate CO

Trachea’s entanglement or strangulation.

measurements can be caused by:

z Reuse, disassembly, cleaning, disinfecting or sterilizing the single patient use CO2 airway adapters z Air flow adapter is damaged. z CO2 Sensor is damaged. z CO2 Sensor is wet or has exterior condensation. z Nitrous oxide, elevated levels of oxygen, helium and halogenated hydrocarbons can influence the

CO2 measurement.

Air flow adapter windows are dirty.

z CO2 Sensor windows are dirty. z Patient’s secretion. z CO2 Sensor is forgotten to reset the air flow adapter. z CO2 Sensor did not be set and compensated according to the environment.

Ambient environmental conditions and sensor application errors, which can affect pulse oximetry

and

readings, are discussed in the Probe section of this manual and in the probe directions for

use.

4-8

Interface and Function

5. Interface and Function

5.1 Main Monitoring Interface

After turning on the monitor, you will enter into the main monitoring interface. Its function is

displaying parameter of patient’s vital signals. Refer to figure 5-1.

(a) Double waveform interface

(b) Single SpO2 module monitoring interface (c) Single CO2 module monitoring interface

Label Description Function

Figure 5-1: Main monitoring interface

SpO

Numeric

Field

PR Numeric

Field

EtCO

Numeric

Field

RR Numeric

Field

SpO

waveform When it is measuring SpO2, it displays SpO2 waveform. It

Display the current SpO2 value. If it doesn’t measure

SpO

, it will display“- - -”

Display the current value. If it doesn’t measure PR it will

display“- - -”.

Display the current value. If it doesn’t measure EtCO2 it

will display“- - -”.

Display the current value. If it doesn’t measure RR it will

display“- - -”.

5-1

Interface and Function

shows a beeline when it doesn’t.

EtCO

waveform When it is measuring EtCO2, it displays EtCO2 waveform.

It shows a beeline when it doesn’t.

Pulse histogram Display the intension of pulse.

Alarm Limits It shows the high and low limit of the parameter.

Alarm Switch When it is displaying means the alarm of this parameter

is closed.

Note: Press the up and down key to switch the main monitoring interface, big chart mode, trend plot

interface, trend table and event table circularly.

5.2 Big Chart Mode

Press down key to switch real-time monitoring interface to big chart mode, as shown in figure 5-2.

(a) Big chart mode of SpO2 and CO2 module

(b) Big chart mode of single SpO2 module (c) Big chart mode of single CO2 module

Figure 5-2: big chart mode

At monitoring interface, press MUTE key can shut down the sound of alarming or resume all

alarms.

5.3 Real-time Trend Interface

5.3.1 Trend Graph Interface

Press down key to enter into real-time trend interface. It displays trends of the parameters such as

5-2

Interface and Function

SpO2 and PR. It records 1 point every 10 seconds acquiescently in 6 pages. Shut down the monitor,

change date, ID and precision will cause losing the current data and the new real-time trend will be

shown. As shown in figure 5-3. Press right/left key to switch every single parameter’s trend graph

screen.

(a) Trend graph interface of Spo2 and CO2 module

(b) Trend graph interface of single SpO2 module (c) Trend graph interface of single CO2 module

Figure 5-3: Trend graph interface

Label Description Function

SpO

scale ruler Mark SpO2 trend graph’s value range and range of

alarm limits.

SpO

trend graph In order to analyze data, protract SpO2 trend in a

period of time according SpO

PR scale ruler Mark PR trend graph’s value range and range of

historical data.

alarm limits.

PR trend graph In order to analyze data, protract PR trend in a

period of time according PR historical data.

EtCO

scale ruler Mark EtCO2 trend graph’s value range and range of

alarm limits.

EtCO

trend graph In order to analyze data, protract EtCO2 trend in a

5-3

Interface and Function

period of time according EtCO2 historical data.

RR scale ruler Mark RR trend graph’s value range and range of

alarm limits.

RR trend graph In order to analyze data, protract RR trend in a

period of time according RR historical data.

Time scale Mark the time scale of this page and time.

Selective frame

Select the page you want to see trends.

for turning pages

over

Marked button Mark trend of current time.

In the trend graph interface, press OK key to enter operation mode, use right and left key to move

focus and press the MENU key to exit operated mode:

◆selective frame for turning pages over: Move focus to the selective frame, press OK key and

then press the right and left key to select the page you want to see its trend circularly. Press OK

key to drop out operation mode.

Mark◆ button: move focus on mark button, press OK key to set a mark of current time at trend

graph. The mark will move leftwards at the trend graph with time.

The real-time trend data will be cleared when open the monitor or change patient’s ID every

time. Pictures are protracted step by step from the right side of the screen until it fills in the

whole screen and then the whole waveform will move leftwards. If there no measured patient,

the picture still move leftwards.

The time to display current trend is different because of different precision. The longest is 18

hours. The historical trends will covered by the new ones if the monitoring time exceeds the

displaying time.

Shutting down the monitor will cause the losing of real-time trend data.

带格式的: 缩进: 左侧:

1.71 字符, 悬挂缩进: 3.6 字符, 项目符号 + 级别: 2 + 对齐位置: 0.74 厘米 + 制表符后于: 1.48 厘米 + 缩进位置: 1.48 厘米, 制表位: 不在 4 字符

5.3.2 Trend Table Interface

Press down key to enter into trend table interface. Every line of the table will display the data of

every parameter in every time which is recorded in the trend plot interface. As shown in figure 5-4.

(a) Trend table interface of SpO2 and CO2 module

5-4

Interface and Function

(b) Trend table interface of single SpO2 module (c) Trend table interface of single CO2 module

Figure 5-4: Trend table interface

5.3.3 Saving Historical Trend

Historical trend will be saved in magnetic disk with the following ways:

 When patient’s ID number is 00, it does not save historical trend data.  When patient’s ID number is 01~99, it can save historical trend data in recent 72 hours. If

there is no enough room for present user, the icon in the status bar will wink to remind you

that the data won’t be save from now on.

 The historical data is saved every 10 seconds acquiescently. The recorded data include the

value of SpO

, PR, CO2, RR.

Historical trend data will be saved if the monitor shut down normally. But if batteries are taken

away abruptly, the data will lose.

Historical trend data will be saved at the moment of changing patient’s ID.

z Historical trend data will be saved if there is a low voltage alarm. And then the monitor enters

into the status of low voltage. Please replace batteries in time. At the status of low voltage, it

will no longer save data even if it shut down normally.

带格式的: 缩进: 左侧:

1.71 字符, 悬挂缩进: 3.6 字符, 项目符号 + 级别: 2 + 对齐位置: 0.74 厘米 + 制表符后于: 1.48 厘米 + 缩进位置: 1.48 厘米, 制表位: 不在 4 字符

5.4 Event Table Interface

Press down key to enter into event table interface. The event table will show the alarm records of

SpO

, PR or ETCO2, RR or all the four parameters. Refers to figure 5-5.

Figure 5-5: Event table

5-5

Interface and Function

Operation:

1. You can use the right and left key to turn over pages circularly after pressing OK key when

the focus is on the selective frame. Press OK key again to drop out turning pages.

The event table will only record alarms happened recently in 10 pages.

5.5 Setting Menu Interface

At the real-time monitoring interface, big chart mode, trend interface and event table interface,

press MENU key to enter menu interface. As shown in figure 5-6.

(a) Menu of SpO2 and CO2 module

带格式的: 缩进: 悬挂缩进:

8.4 字符, 项目符号 + 级别: 2 + 对齐位置: 0.74 厘米 + 制表符后于: 1.48 厘米 + 缩进位置: 1.48 厘米, 制表位: 不在 4 字符

(b) Menu of single SpO2 module (c) Menu of single CO2 module

Figure 5-6: Menu interface

Operation:

1. In the menu, press MENU key can exit.

2. Use up and down key to select different option.

3. Press OK key to affirm your option.

4. After that, a dialog box will come out.

5.5.1 Setting Alarm Limits

z The monitor’s alarm function will be affected by environmental light, EMC and noise and so on.

z The sounds of alarms and the wink of monitoring data on the screen must be audible and visual

by operator.

5-6

Interface and Function

(a) Set alarm for SpO

(b) Set alarm for single SpO

module (c) Set alarm limits for single CO2 module

Figure 5-7: Set alarm limits

and CO2 module

Operation:

1. Use up, down, right, left key to move focus. When the focus is on OK or Cancel button, press

OK key can save or give up saving settings, then the dialog box will disappear. Pressing

MENU key is equal to choosing Cancel button.

2. Press OK key to enter compiling state, and use right and left key to change limits, then press

OK to exit.

3. When the focus moves to CO

RR. (Only for SpO

and CO2 module).

option, press OK key to switch to set alarm limit of EtCO2 and

z If alarm default limit is changed, a decimal point appears behind the displayed value during

monitoring. The decimal point remains on display until the limit is returned to its default value.

z It should be only the professional to adjust the alarm high/low limit. Alarm high limit can not lower

than alarm low limit.

z The alarm system will be invalid if set alarm high/low limit out of the range of alarm limit. z When patient needs to be looked after specially, inadequacy alarm limit will cause the delay or

invalidation of alarm signal.

z Make sure that the monitor default alarm settings are appropriate for the specific patient being

monitored.

5-7

5.5.2 Setting SpO2

Interface and Function

In the setting menu, you can choose “Set SpO

” option. As shown in figure 5-8.

Figure 5-8: Set SpO

(Not suitable for single CO2 module)

Operation:

1. Use up, down, right, left key to move focus. When the focus is on OK or Cancel button, press

OK key can save or give up saving settings, then the dialog box will disappear. Pressing

MENU key is equal to choosing Cancel button.

2. Move the focus to “Pleth Speed” , “Average Pulse” or “ Discolor Time”, press OK key first and

then use up and down key to change the value, press OK to affirm your setting.

NO. Name Option

Pleth Speed High, Low

Average Pulse 4,8,16

Discolor Time 1, 10, 30. It means the interval to change the color of Spo

waveform according alarming level when alarm occurs.

5.5.3 Setting CO2

In the setting menu, you can choose “Set CO

” option. As shown in figure 5-9.

Figure 5-9: Set CO

(Not suitable for single SpO2 module)

Operation:

1. Use up, down, right, left key to move focus. When the focus is on OK or Cancel button, press

OK key can save or give up saving settings, then the dialog box will disappear. Pressing

MENU key is equal to choosing Cancel button.

2. User can move focus to switch CO

, set the speed of waveform, zeroing, parameters of CO2.

NO. Name Description NO. Name Description

Press barometric pressure 4 O

Temp gas temperature 5 Bgas balance gas

Unit current CO

units 6 Ane anesthetic agent

compensation

5-8

Interface and Function

5.5.4 Setting Patient’s Information

In the setting menu, you can choose “Patient Info” menu to set patient’s ID, sex and type. As

shown in figure 5-10.

Figure 5-10: Set patient’s information

Operation:

1. Use up, down, right, left key to move focus. When the focus is on OK or Cancel button, press

OK key can save or give up saving settings, then the dialog box will disappear. Pressing

MENU key is equal to choosing Cancel button.

2. You can change patient’s ID from 0 to 99.The types of patient are adult, pediatric and neonate

and the sexes are male and female.

3. When you choose the New button, the system will auto-generate a new ID. You can’t use the

New button, if there no available ID.

4. If you choose an ID that has never been used, press OK key can change ID number and then

the dialog box will exit. If the ID you choose is existing, it will remind you to substitute the

former ID or cancel your operation.

5. If you choose to substitute the ID, the historical data of this ID will be cleared, and the restart

to record new data, then the dialog box will disappear. If you choose to cancel your setting,

then return to setting ID interface with the disappearance of the dialog box.

5.5.5 Setting Volume

z Do not turn off the audible alarm or decrease the audible alarm volume if patient safety could be

compromised.

Figure 5-11: Set volume

Operation:

1. Use up, down, right, left key to move focus. When the focus is on OK or Cancel button, press

OK key can save or give up saving settings, then the dialog box will disappear. Pressing

MENU key is equal to choosing Cancel button.

2. Adjust the volume with the right and left and press the up and down key to move the focus,

and then press OK to confirm your setting.

5-9

Interface and Function

5.5.6 Setting Time and Date

Figure 5-12: Set time and date

Operation:

1. Use right and left key to move focus, and press OK to enter compiling state, press OK again

to exit.

2. When the focus is on OK or Cancel button, press OK key can save or give up saving settings,

then exit from the dialog box.

5.5.7 Setting Trend

Select the “Set trend “submenu in the setting menu and you can adjust the trend record step. As

shown in Figure 5-13.

z If you change the steps, the data have saved will be lost.

Figure 5-13: Set trend

Operation:

1. Use up, down, right, left key to move focus. When the focus is on OK or Cancel button, press

OK key can save or give up saving settings, then the dialog box will disappear. Pressing

MENU key is equal to choosing Cancel button.

2. User can move focus to step, press the up/down key to change step. The default value is 10

seconds.

NO. Name

Runtime Trend Step 1, 5,10,30,60. It means the trend data saving interval in the

Option

monitor.

History Trend Step 1, 5,10,30,60. It means the trend data saving interval you can

watch on PC.

5.5.8 Data Output

In the setting menu, you can choose “data output” option to enter data output interface. As shown

5-10

in figure 5-14.

Interface and Function

Figure 5-14: Data output

Operation:

1. Open the “data output “interface in the setting menu.

2. Plug wireless USB Dongle into USB port in PC, and then run the historical data analytical

software. Choose the “Connect instrument” of the software.

3. If it has found instrument, the software will remind you to choose the patient’s ID which you

want to upload to PC. After that, you can upload patient’s data to PC. You can also delete

appointed patient’s data.

4. At the process of sending data, you can press Stop button to stop it. Then the dialog box will

disappear.

5.5.9 Set Module

Figure 5-15: Set Module

There are three modules of the monitor including the SpO2 and CO2 Module, the Single SpO2

Module and the Single CO

Module. You can choose one of these to run after entering “Set Module”

submenu.

5.5.10 Resume Settings

Entering into the “Reset setting “submenu can resume all settings you have changed. As shown in

figure 5-16.

Figure 5-16: Resume settings

5.5.11 System Information

System information includes the information of hardware, software and product and so on. The

interface is tolerant and can not to be changed. As shown in figure 5-17.

Figure 5-17: System information

Operation:

1. Press OK key to exit the dialog box.

5-11

Interface and Function

5.6 Audible and Visual Indication

The following audible indications do not change with symbols, key board or visual indication:

Label

Description

Setup

When self testing, the indicator

Visual indication Audible indication

One sound ,“dee”

will wink red, green and yellow

color once.

Pulse sound / One sound ,“dee”

Sensor falls off

Loss of finger

Loss of pulse

The red light will wink and the

icon

will be displayed.

The red light will wink and the

icon

will be displayed.

The red light will wink and the

icon

will be displayed.

Dee,dee,dee-dee,dee

Period: 10s

Dee,dee,dee-dee,dee

Period: 10s

Dee,dee,dee-dee,dee

Period: 10s

Poor signal

The icon

will be displayed.

Dee,dee,dee-dee,dee

Period: 10s

Low voltage

The red light and the icon

will wink.

Alarm sound The red light will wink in high

priority. The yellow light will wink

in medium priority. And the

Dee,dee,dee-dee,dee

Period: 10s Dee,dee,dee

Period of high priority:10s Period of medium priority:25s

related parameter values will

wink at the same time.

5-12

Monitoring SpO2

6. Monitoring SpO2

6.1 Overview

measures functional blood oxygen saturation. It measures the percentage of oxyhemoglobin. It

SpO

does not measure carboxyhemoglobin or methemoglobin. For example, if 97% of red blood cells in the artery are oxygenated, then blood has 97% blood oxygen saturation. The monitor SpO would be 97.

SpO

measurement is a non-invasive, continuous measurement through a SpO2 sensor attached to a

patient’s finger. The sensor is connected directly to the SpO for SpO

: percentage (%), pulse rate, and SpO2 waveform.

module. There are three types of display

6.2 Principles of Measurement

Pulse oximetry is based on two principles: 1.That oxyhemoglobin and deoxyhemoglobin differ in their absorption of red and infrared light (i.e., Spectrophotometry), and 2.that the volume of arterial blood in tissue (and hence, light absorption by that blood) changes during the pulse (i.e., plethysmography). A pulse oximeter determines SpO

by passing red and infrared light into an arteriolar bed and measuring

changes in light absorption during the pulsatile cycle. Red and infrared low-voltage light-emitting diodes (LEDs) in the oximetry probe serve as light sources; a photodiode serves as the photo detector.

Because oxyhemoglobin and deoxyhemoglobin differ in light Absorption, the amount of red and infrared light absorbed by blood is related to hemoglobin oxygen saturation .To identify the oxygen saturation of arterial bemoglobin, the monitor uses the pulsatile nature of arterial flow. During systole, a new pulse of arterial blood volume and light absorption increase.

value reading

During diastole, blood volume and light absorption reach their lowest point .The monitor bases its SpO

measurements on the difference between maximum and minimum absorption (i.e.,

Measurements at systole and diastole). By doing so, it focuses on light absorption by pulsatile arterial blood, eliminating the effects of nonpulsatile absorbers such as tissue, bone, and venous blood.

The Pulse oximeter determines SpO

and pulse rate by passing two wavelengths of light, one red and

one infrared, through body tissue to a photodetector. During measurement, the signal strength resulting from each light source depends on the color and thickness of the body tissue, the probe placement, The intensity of the light sources, and the absorption of the arterial and venous blood (including the time varying effects of the pulse) in the body tissue. (Refer To Figure 6-1)

Figure 6-1: SpO2 theory of operation

The Pulse Oximeter processes these signals, separating the time invariant parameters (tissue thickness, skin color, light intensity, and venous blood) from the time variant parameters (arterial volume and SpO

) to identify the pulse rate and calculateoxygen saturation. Oxygen saturation

6-1

Monitoring SpO2

calculations can be performed because oxygen saturated blood predictably absorbs less red light than oxygen depleted blood.

6.2 Abnormal State of SpO

Measurement:

After turning on the monitor, if the sensor is installed incorrectly or there are other wrong operations,

the following situation may happen:

1) The SpO

“

sensor has already been inserted, but the sensor not attached to the finger, the icon

” will wink and SpO2 and PR display area has display“- - -”，At the same time, the monitor

will generate lost reminder sound in every 10 seconds.

2) Pulse search mode: If patient is connected with the sensor, the monitor attempts to search pulse.

The icon “ ” will wink. At the same time, display shows display“- - -”in %SpO

and PR areas.

Normally the search mode process is approximately 10 seconds. If the pulse search is failed, the

monitor generates high alarm.

3) The sensor falling off. The icon “

” will be displayed.

4) Hinting poor signal. The icon “ ” will displayed.

6.4 Directions for SpO

Single patient use SpO

the adult, pediatric's blood oxygen degree of saturation (SpO

Sensor Use

sensor and SpO2 saturation monitor compose the system to use to examine

) and (or) the arteries rate (PR)

physiological parameter and so on. The use situation is not restricted in the specialized medical

establishment the patient guardianship room, the operating room, the first-aid room, the emergency

room and the technique the observation room. Its use cycle generally is 7days to 15 days for a person

in hospitalized.

z The sensor isn’t suitable for continuous and long term SpO

monitoring. Continuous and long term

monitoring may cause skin to become irritated, reddening, blistering or necrosis.

z The SpO

sensor has passed biologic compatibility experiments like cell’s toxicity, stimulative test

under skin and scratch test and so on.

Steps :

1） Hold the sensor with its opening towards the patient’s index finger (A). The sensor should be oriented in such a way that the sensor side with a cable is positioned on the top (B). If an index

finger cannot be positioned correctly, or is not available, other fingers can be used.

6-2

Monitoring SpO2

Figure 6-2: Placement of sensor

2） Insert the patient’s index finger into the sensor until the fingernail tip touches the end of the sensor. Adjust the finger to be placed evenly on the middle base of the sensor (C). 3） Plug the sensor into the monitor and verify proper operation as described in the monitor operator’s manual. 4） Inspect the monitoring site every 4 hours for skin integrity. 5） Before each use, surface-clean sensor and cable with a soft gauze pad by saturating it with a solution such as 70% isopropyl alcohol. If low-level disinfection is required, use a 1:10 bleach

solution.

z Do not sterilize by irradiation steam, or ethylene oxide. z Do not use a blood pressure cuff or arterial blood pressure measurement device on the same limb

as the sensor.

6.5 Measuring Restriction

6.5.1 The following may affect the accuracy of SpO

measurement:

 High frequency electrical interference from the monitor itself or from ambient electrical

instruments connected to the system.

 Patient’s excess movements.

 Inductive current generated from MRI can cause burn.

 Outside light radiation.

 Incorrect sensor placement.

 Sensor temperature (suitable temperature range should be 28 ℃ - 41 )℃

 The same limb used for sensor, NTBP cuff, artery tube or inner tube.

 Presence of COHb, MetHb and dyestuff.

 Low signal.

 Bad perfusion on sensor site.

 Coma, anemia, low temperature and insufficient blood flow caused by drugs.

6-3

Monitoring SpO2

z The maximum time duration for one sensor site in use should not be over 4 hours. The sensor

surface temperature should not be higher than 41ºC, or it may cause burn.

During continuous monitoring, sensor site should be cleaned at least every 12 hours. Otherwise it

may result in inaccurate measurements.

6.5.2 Inaccurate measurements can be caused by:

 Incorrect application of the sensor;

 Patient’s finger is too big or its blood cycle doesn’t well;

 Failure to cover the sensor site with opaque material in high or ambient light conditions;

 prolonged and/or excessive patient movement;

 Intravascular dyes, such as indocyaninegreen or methylene blue;

 Interavascular dyes or externally applied coloring, such as nail polish or pigmented cream;

 Venous pulsations;

 Significant levels of dysfunctional hemoglobins

 Lack of supplying blood.

6.5.3 Loss-of-pulse signal can occur for the following reasons:

 The sensor is applied too tightly;

 Defibrillation;

 A blood pressure cuff is inflated on the same extremity as the one with the sensor attached;

 There is arterial occlusion proximal to the sensor;

 Poor peripheral profusion;

 Losing of pulse or stopping of heart.

Select an appropriate sensor, apply it as directed, and observe all warnings and cautions presented in

the directions for use accompanying the sensor. Clean and remove any substances such as nail polish

from the application site. Periodically check to ensure that the sensor remains properly positioned on

the patient.

High ambient light sources such as surgical lights (especially those with a xenon light source), bilirubin

lamps, fluorescent lights, infrared heating lamps, and direct sunlight can interfere with the performance

of a SpO

sensor. To prevent interference from ambient light, ensure that the sensor is properly applied,

and cover the sensor site with opaque material.

If patient movement presents a problem, try one or more of the following remedies:

 Verify that the sensor is properly and securely applied;

 Move the sensor to a less active site;

 Use an adhesive sensor that tolerates some patient motion;

 Use a new sensor with fresh adhesive backing;

 Try to keep patient quiet.

z Failure to cover the sensor site with opaque material in high ambient light conditions may result in

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6-4

Monitoring SpO2

inaccurate measurements.

z You can select and use sensor to realize how to deal with patient and environment. z Do not sterilize by irradiation steam, or ethylene oxide. Wipe the monitor with cloth dampened with

soft suds and then wipe surfaces dry. Wipe the sensor with cloth with alcohol if necessary. Note:

Do not spray or pour any liquid directly on the monitor, accessories or consumables.

z Pulse oximetry readings and pulse signal can be affected by certain ambient environmental

conditions, sensor application errors, and patient conditions.

z Tissue damage can be caused by incorrect application or inappropriate duration of use of a SpO

sensor. Inspect the sensor site as directed in the sensor Directions for Use.

z Inspect the monitoring site every 4 hours for skin integrity.

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6-5

Monitoring SpO2

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6-6

Monitoring CO2

7. Monitoring CO2

7.1 Overview

The CO2 Sensor is used for the continuous measurement of CO2 and respiratory rate. The sensor

measures CO

molecules absorb infrared (IR) light energy of specific wavelengths, with the amount of energy

absorbed being directly related to the CO

sample containing CO

light energy) is measured. This signal is then compared to the energy of the IR source and adjusted to

accurately reflect CO

concentration of CO

optical changes in the sensor, allowing the system to remain in calibration without user intervention.

7.2 Principles of Measurement

CO2 monitoring is to monitor the respiration of a patient by detecting the concentration of CO2

generated during respiration. The maximum concentration of CO

End-Tide CO Inspiration CO

out via breathing system. The concentration of CO

situation of metabolizing and breathing system. If the concentration of CO

metabolism is over active, such as blood poisoning or acute fever. If the concentration of CO

is commonly due to a weak output ability of the heart, or the heartbeat stopped, or insufficient blood

flow with less oxygen. Monitoring CO

metabolizing during anaesthesia.

by using the infrared absorption technique. The principle is based on the fact that CO2

concentration. When an IR beam is passed through a gas

, the electronic signal from the photo detector (which measures the remaining

concentration in the sample. The CO2 Sensor’s response to a known

is stored at the factory in the sensor’s memory. A reference channel accounts for

at the end of exhalation is called

(EtCO2). The minimum concentration of CO2 at the end of inspiration is called

(FiCO

). CO2 is generated by cells in the body during metabolizing, and is breathed

breathed out from the lung reflects directly the

is high, it means that

is low, it

is used to warn the doctor of the abnormal breathing and

The concentration of CO

the acceptable value is 38mmHg (5%) when air pressure is 760mmHg. The concentration of CO

varies rapidly from 0% to 5%. To detect the concentration of CO

is represented as a pressure level, with ‘mmHg’ or % as its unit. Generally,

accurately, the monitor needs to be

very sensitive.

The monitor is used to measure the EtCO

and respiration rate of adult, infant and neonatal patient

7.3 Medical Use of CO2 Sensor

z The CO2 Sensor is used to continuously monitor carbon dioxide and report ETCO2, inspired CO2

and respiratory rate of the intubated and non-intubated adult, pediatric, and neonatal patient.

z The CO

care, anesthesia, medical/surgical units, LTAC units, emergency department, sleep labs and

during intra-hospital transport and inter-hospital transport.

z For use in monitoring patients in respiratory distress, respiratory arrest or that have asthma,

COPD or other disorders where the patient’s ETCO

the treatment of the patient.

z For use in monitoring patients pre- and post-intubation. z To assist in the setup, management and weaning of the patient that is connected to a

“conventional” mechanical ventilator.

Sensor is indicated for use in care areas such as, but not limited to critical care, intensive

and capnogram will benefit the caregiver in

7-1

Monitoring CO2

7.4 CO2 Sensor Adapter Zero

The sensor is compatible only with appointed CO2 airway adapters. Each airway adapter has a unique

set of optical characteristics. The adapter zero allows the CAPNOSTAT to adjust to the optical

characteristics of each of the different adapter types. An “Adapter Zero” is a quick process that allows

the Host system to adjust to the special characteristics of a particular CO

when requested. Such a request may occur the first time a particular CO

particular Host, or if a change is detected in the CO

Sensor.

To perform an Adapter Zero:

1）Connect the CO 2）Open the Host’s CO

onto a clean and dry CO

Sensor to the Host.

switch. If it is the first time you open the CO2 switch , Place the CO2 sensor

adapter that is exposed to room air and away from all sources of CO2,

including the ventilator, the patient’s breath and your own. Do not conduct any operation in 20

minutes.

3）Open the MENU and select ”Set CO 4）Choose “clear” and the CO

information column will display “ CO2 Zeroing” and “ CO2 Zero OK”

” option.

in turn. At the progress of zeroing, do not conduct any operation including breathing, key-press

and so on. Otherwise, the zeroing operation will fail. The time for a zero is 15-20 seconds. If

failed, the information column will hint “CO

needs zeroing”, choose “Clear” can zero the

adapter again.

z For optimal results, connect the CO

Sensor to an adapter and wait 2 minutes before performing

the Adapter Zero procedure.

Sensor; it is necessary only

Sensor is connected to a

z CO2 readings and respiration rate can be affected by certain ambient environmental conditions,

sensor application errors, and patient conditions.

z Check whether CO

adapter is damaged or not. Do not use damaged CO2 adapter.

z If the CO2 waveform (Capnogram) appears abnormal, inspect the CO2 airway adapters and

replace if needed.

z Replace the CO

airway adapters if excessive secretions are observed.

z Monitor the CO2 waveform (Capnogram) for elevated baseline. Elevated baseline can be caused

by sensor or patient problems.

7-2

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Data output

8. Data Output

8.1 Driver Installations and Copy of Data Analysis Software

Install the driver “F32x Express USB Driver” and copy the tool folder ” History Data Viewer” from

the enclosed CD to PC before transmitting of data derived from the monitor to PC.

8.1.1 Install USB Drivers

F32x Express USB Drivers is used to drive USB dongle, to install as follows:

1）Insert the enclosed CD into your computer.

2）Plug the USB dongle into the USB faucet in PC, and you will see an automatic popup window

“Welcome to the Found New Hardware Wizard”. Choose “Install from a list or specific location”. Note:

If there is no automatic window, you may double left click the icon

the desktop.

3）Click “Next” and see “Hardware Update Wizard” window as below.

on the bottom right corner of

8-1

Data Output

4）Click “Browse” and choose the path G:\Driver\ F32x Express USB Driver. Click “Next” and start

installation.

5）After installation, you will see the window “Completing the Found New Hardware Wizard”.

8-2

Data output

Click “Finish” to complete the installation of F32x Express USB Drivers. Once the driver is

installed on PC, there is no need to install for the second time.

8.1.2 Copy the Folder “History Data Viewer”

The software in this folder has the functions of data output, data analysis and printing report.

Copy the folder” History Data Viewer” from CD to PC and enter into it.，dbclick the icon “

the main interface of the History Data Viewer software. Click “OK” to start it.

” to start

8-3

8.2 Transmit and Delete Data

Data Output

z At the process of data transmitting and deleting, please don’t chose the History Data View

software or pull the USB adapter out, otherwise the process will be failure.

z After data transmitting and deleting, please pull out the USB adapter firstly, and then chose the

History Data View software.

1）Put the monitor into 2 meters around the PC, and open it. 2）Press the MENU key to enter into the dialog box of “Data Output “. The monitor will stick on the

dialog box as shown in the following picture:

3）Open the history data viewer software and click the button ”

” at the top left corner can connect

the monitor and PC wirelessly. If connected successfully, patient’s history data which have stored in

the monitor will be displayed at the left side column of the monitoring software. Select one patient’s

ID, click with the right key and choose “Transmit data” or “Delete data” to send this ID’s data to PC

or delete the stored trend data of the ID in monitor. As shown below:

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8-4

Accessories

9. Accessories

9.1 Standard Configure of NT1D

1）Host monitor one 2）SpO

3）CO

4）Charging pedestal one

5）Chargeable batteries four 4xAA,2400mAh,Ni-MH chargeable batteries. 6） AC adapter one Input a.c.100-

7） Safeguard jacket one 8） Wireless USB Dongle one 9） Driving CD one 10）Operation Manual one 11）Maintenance card one 12）Package bill one

Sensor one Solaris medical technology company SpO2 Sensor,

Model: D400AL-160108.

Sensor one Respironics company

Capnostat 5 mainstream CO

sensor

240V,50/60Hz，output d.c. 9V, (operation power) and 6.0V（Recharging power）.（Confirm to EN 60601-1）

删除的内容: ~

9.2 Optional Accessories of NT1D

User can buy accessories from the local agent if necessary. The following are the accessories:

Num Type Description Manufacturer

1 D400A-160108 Digital One Adult SpO2 Sensor Solaris

2 D400P-160108 Digital One Pediatric SpO2 Sensor Solaris

3 Y400N -160108 Digital Y-type Neonatal SpO2 Sensor Solaris

4 DP400A-160108 Digital One Use Only SpO2 Sensor-Adult Solaris

5 DP400N/A-160108 Digital One Use Only SpO2 Sensor-Neonate/Adult Solaris

6 DP400P-160108 Digital One Use Only SpO2 Sensor-Pediatirc Solaris

7 DP400I-160108 Digital One Use Only SpO2 Sensor-Infant Solaris

8 S400A-160108 Digital Adult Finger SpO2 Sensor Solaris

9 S400P-160108 Digital Pediatric Finger SpO2 Sensor Solaris

9-1

Accessories

10 T400A-160108 Adult Soft-Finger SpO2 Sensor Solaris

11 T400P-160108 Pediatric Soft-Finger SpO2 Sensor Solaris

12 W400AN-160108

13 WP400PI-160108

Digital Wrapped and tied SpO

Sensor-Neonate/Adult

Digital Wrapped and tied SpO

Sensor- Pediatirc / Infant

Solaris

14 / LoFlo sidestream CO2 sensor Respironics

9-2

Troubleshooting and Maintenance

10. Troubleshooting and Maintenance

z If you are uncertain about the accuracy of any measurement, check the patient’s vital signs by

alternate means; then make sure the monitor is functioning correctly.

z The cover should be removed only by qualified service personnel. There are no user-serviceable

parts inside.

z Do not spray or pour any liquid directly on the monitor, accessories or consumables. Otherwise

may cause damage to the monitor.

If you experience a problem while using the monitor and are unable to correct it, contact qualified

service personnel or representative. The monitor service manual, which is for use by qualified service

personnel, provides additional troubleshooting information.

10.1 Troubleshooting Guide

1. Monitor does not turn on after pressing the power switch.

 Check power cable connection.  Replace or recharge the battery pack, or connect to AC power.  Be sure the battery pack is in the monitor and inserted properly.

2. One or more showed elements or indicatory icons do not bright when self testing.  Do not use the monitor and contact technical services department.

3. Indicatory icon of searching pulse is winking more than 10 seconds.  Check whether sensor is suitable or connected correctly following SpO

sensor and its cable connection. Chang other patient to use the sensor. Use another sensor or its

prolonged cable.

 Lacking of blood supply may cause the failure of tracing pulse, so check the patient or monitor

operator. Replace if necessary, move the sensor to a new site.

 Patient’s movement may interfere in the failure of tracing pulse. Keep patient still. Check whether

the sensor is firm. Replace if necessary, move the sensor to a new site.

 The probe may be emplaced too tight. Environmental light may also affect monitoring. A blood

pressure cuff is inflated on the same extremity as the one with the sensor attached, Replace

sensors if necessary.

 EMI, Remove disturbing equipment.

4. No pulse shown on the bar-graph.

 Check sensor connections to the patient cable and to the monitor.  Reposition the sensor.  Try a new sensor or connect your authorized repair center for help.

5. PR, SpO  Reposition the SpO

, EtCO2, RR Pulse rate is erratic, intermittent, or incorrect. (May caused by EMI)

and CO2 sensor.

 Patient must remain still to obtain an accurate measurement.  Close nearby equipment and then open it to find interferential equipment out.  Change the orientation and position of interferential equipment.

using direction. Check

带格式的: 缩进: 左侧: 0 厘米, 悬挂缩进: 3.6 字符, 项目符号 + 级别: 1 + 对齐位置: 0 厘米 + 制表符后于: 0.74 厘米 + 缩进位置: 0.74 厘米, 制表位:

1.71 字符, 列表制表位 + 不在 2 字符

带格式的: 缩进: 左侧: 0 厘米, 悬挂缩进: 3.6 字符, 项目符号 + 级别: 1 + 对齐位置: 0 厘米 + 制表符后于: 0.74 厘米 + 缩进位置: 0.74 厘米, 制表位:

1.71 字符, 列表制表位 + 不在 2 字符

10-1

Troubleshooting and Maintenance

 Let interferential equipment far away from this monitor.

6. The monitor switches off automatically.

 Replace or recharge battery.  Check connections and correct problem.  If previous actions are not effective, contact authorized service representative.

10.2 Technical Assistance

If you need technical information and sustain or ordered parts and operation manual, please

contact your local representative, and tell them is software’s version number of this monitor.

10.3 Factory Default Alarm Range Values

This monitor has default values when it is shipped to leave factory. technician has described how

to change default values in detail at the operation manual.

Factory default alarm range values:

Default value of alarm high

Default value of alarm low

Alarm parameter(unit)

limit

Adult Pediatric Neonate Adult Pediatric Neonate

EtCO2（mmHg）

RR（BPM）

SpO2（%）

60 60 60 0 0 0

150 150 150 3 12 12

100 95 95 85 80 80

PR（BPM） 100 200 200 55 100 100

10.4 Returning the Monitor

If it is necessary to return the monitor for repairs, call the local representative for shipping

instructions.

To repack the monitor, disconnect the accessories from the instrument and wrap each item

separately. Pack them in the original shipping carton. If the original carton is unavailable, use a

suitable box filled with the appropriate amount of packing material.

If the monitor malfunctions, carefully package the monitor with the consumable used at the time of

malfunction and return it with the monitor for inspection.

10.5 Maintenance and Cleaning

z The cover should be removed only by qualified service personnel. There are no user-serviceable

parts inside.

z Turn the monitor off before cleaning. z Do not spray or pour any liquid directly on placket of the monitor, accessories, connector, switch or

10-2

带格式的: 缩进: 左侧: 0 厘米, 悬挂缩进: 3.6 字符, 项目符号 + 级别: 1 + 对齐位置: 0 厘米 + 制表符后于: 0.74 厘米 + 缩进位置: 0.74 厘米, 制表位:

1.71 字符, 列表制表位 + 不在 2 字符

Troubleshooting and Maintenance

crack. Otherwise it will dose damage to them.

z Do not autoclave, or immerse the monitor in liquid. z If disinfection is required, wipe the monitor's surfaces with a soft cloth moistened with commercial

nonabrasive cleaner. Do not allow any liquid to enter any of the monitor's opening.

z Do not touch or rub the display window with abrasive, apparatus, brush, shaggy material or any

other stuff that may do damage to the display window.

z If there are any internal parts of the monitor exposed, please contact qualified service personnel to

deal with it. Please follow your local governing ordinances regarding disposal monitor when it

dosen’t run.

z Dispose or recycle of batteries and retired sensors and the monitor’s accessories according to

standard operating procedures or local regulations for the disposal of contaminated medical

waste.

z This monitor can use disabled batteries, please install new ones.

You can clean and disinfect the surface of monitor and sensor. (Sensor is the only part that

contacts to patient, so you should clean it every time after use.)

10.5.1 Cleaning and Disinfecting the Monitor

 To clean the monitor’s surface: To clean the monitor’s surfaces, dampen a soft cloth with a

commercial, non-corrosive cleaner or alcohol 70%,and wipe the top, bottom, and front surfaces

lightly.

 To disinfect the monitor: Use a cloth dampened with a 10% aqueous solution of hypochlorite

(bleach).

10.5.2 Cleaning and Disinfecting SpO

 You can use a tampon or soft cloth dampened with alcohol 70% to wipe the SpO

dry it completely with dry cloth. The same to SpO

reusable SpO

SpO

sensor has its own way to clean.

sensor. Read SpO2 sensor’s direction carefully before cleaning. Every kind of

sensor, and then

sensor’s LED and receiver. Clean and disinfect

 If low-level disinfection is required, use a 1:10 bleach solution.

10.5.3 Disinfecting Cable

 Clean and disinfect cables with 3% hydrogen peroxide, or 70% isopropyl alcohol.

10.5.4 Cleaning and Disinfecting CO

Sensor

z Cleaning and Disinfecting  Use a cloth dampened with isopropyl alcohol 70%, a 10% aqueous solution of sodium

hypochlorite (bleach), disinfectant spray cleaner such as Steris Coverage® Spray HB, ammonia,

or mild soap.

 Wipe down with a clean water-dampened cloth to rinse and dry before use. Make certain that the

sensor windows are clean and dry before reuse.

Cleaning adapter

Reusable adapters (Before reusing the adapter, ensure the windows are dry and residue free and that

the adapter has not been damaged during handling or the cleaning/disinfecting process

.):

 Clean by rinsing in a warm soapy solution followed by soaking in a liquid disinfectant such as

isopropyl alcohol 70%, a 10% aqueous solution of sodium hypochlorite (bleach), a gluteraldehyde

2.4% solution such as Cidex®, Steris System 1® or ammonia. It should then be rinsed out with

sterile water and dried.

 May be disinfected using the methods listed below:

1）Steam Autoclave - adult adapters only;

10-3

Troubleshooting and Maintenance

2）Immerse and soak in Cidex® or equivalent 2.4 glutaraldehyde solution for a 10 hour soak. 3）Immerse and soak in Perasafe® or equivalent peracetic acid. 26% solution for a 10-minutes

soak.

4）Cidex® OPA - follow the manufacturer’s instructions for use.

Disposable adapters:  Treat all single patient use airway adapters in accordance with institutional protocol for single

patient use items.

 DO NOT insert any object, such as a brush, into the CO

occur to the CO

windows.

airway adapter. Irreparable damage may

z Maintenance Schedule

Sensor should be compared against calibration gas every 12 months.

NOTE: Accuracy is affected by temperature and barometric pressure. z CO

The following procedure should be performed to check the CO

Accuracy Check

accuracy of the Sensor. It is

recommended that this procedure be included as part of a periodic maintenance schedule. 1）Zeroing. Refers to chapter 7 “7.4 2）Calibration. Open the MENU and select “set CO

sensor adapter zero”.

” option. You can adjust all parameter’s value

(Pressure, temperature, unit, oxygen compensation and so on) according to the actual environment.

Press OK key can confirm your calibration.

Do not autoclave, ethylene oxide sterilize, or immerse the monitor and its accessories in liquid.

z z Turn off the monitor before cleaning.

带格式的: 缩进: 悬挂缩进:

8.4 字符, 项目符号 + 级别: 2 + 对齐位置: 0.74 厘米 + 制表符后于: 1.48 厘米 + 缩进位置: 1.48 厘米, 制表位: 不在 4 字符

z If there are any internal parts of the SpO2 and CO2 sensor exposed, please contact qualified

service personnel to deal with it.

10.6 Periodic Safety Checks

The following safety checks should be performed every 24 months by a qualified person who has adequate training, knowledge, and practical experience to perform these tests.

● Inspect the equipment for mechanical and functional.

● Inspect the safety relevant labels for legibility.

● Verify that the device functions properly as described in this operator's manual.

If the monitor is not functioning properly or fails any of the above tests, do not attempt to repair the monitor. Please return the monitor to the manufacturer or to your distributor for any required repairs.

10.7 Guarantee

The company warrants the monitor at the time of its original purchase and for the subsequent time

period of twelve months for the original purchaser. The company warrants SpO

at the time of its original purchase and for the subsequent time period of three months.

10-4

Sensor free of defects

Troubleshooting and Maintenance

The warranty does not cover the followings:

● The monitor serials number of the label is teared off or can not be recognized.

● Damage to the monitor resulting from misconnection with other devices.

● Damage to the monitor resulting from accidents.

● Changes performed by users without the prior written authorization of the company.

Customer Service Department Tel: 86-755-26520739

10-5

Troubleshooting and Maintenance

This page is intentionally left blank.

10-6

Appendix A

Appendix A: Specifications

A.1 Basic parameter

SpO

, PR, EtCO2, RR.

A.2 Average operation time

≥1000 hours.

A.3 Normal operation time

a) Environment temperature range:（0 ～ 50）℃,

b) Relative Humidity range: ≤ 95 %, c) Atmospheric pressure range:（700～1060）hPa,

d) Power Voltage: AC 100V-

e) Power frequency: 50/60 Hz,

f) Battery type: 4xAA size Ni-MH rechargeable battery or alkaline battery (Forbidden to charge

alkaline battery).

A.4 Safety requirements and classifications

a) Electric shock type: Type II equipment with internal power supply.

b) Electric shock degree: All application parts are BF type.

c) Harmful liquid material proof degree: Liquid proof.

d) Disinfection: follow manufacturer’s recommended methods.

e) Safety on flammable gas: not suitable to use where flammable gas is present.

f) The monitor has applicable.

g) Power supply:

Internal power supply:4.4～6.0V（4xAA size battery）,

II type power adapter: input a.c.100-

240V,

240V,50/60Hz，output d.c. 9V, (operation power) and 6.0V

删除的内容: ～

删除的内容: ~

（Recharging power）.

h) The monitor has signal input and signal output parts, i.e., keypad, LCD, wireless interface.

i) Using external power supply, the monitor is a continuous working system.

A.5 Trend data transfer

1) Wireless, via USB dongle for PC end

2) RF frequency: 2.440GHz

3) Modulate mode: GFSK

4) Effective transfer distance（clear area without interferential source or barrier）: ≤10m

5) Transfer speed: ≤ 40kbps

6) Transfer time: ≤ 40secs per ID

7) Power consumption: Rx or Tx Peak ≤13mA

A.6 SpO

■Measurement range:(0 ～ 100）%.

■Measurement accuracy:(70 ～ 100)%,±2 %,

(0 ～ 69)%, not required.

A.7 PR

■Measurement range: (30 ～ 250)bpm,

A-1

Appendix A

■Measurement accuracy: 1 bpm or ±2%, take the bigger one.

A.8 EtCO

■Measurement range: 0~150mmHg.

■Resolution: 0.1mmHg (0~69mmHg), 0.25mmHg (70~150mmHg).

■Measurement accuracy:

±2mmHg (0~40mmHg)

±5% (41~70mmHg)

±8% (71~100mmHg)

±10% (101~150mmHg)

A.9 RR

■Measurement range: 0~150 BPM

■Measurement accuracy: ±1 BPM

A.10 Alarm

■Alarm Mode:

Priority

High Medium

Mode

Low voltage, Pulse lost, Sensor

Technical alarm

off, Cable off, CO2 sampling line

off, No breath.

Physiological

alarm

Parameter’s value exceed limits(The priority can be

adjusted)

Dee,Dee,Dee -Dee,Dee

Dee,Dee,Dee

Audible alarm

Period: 10secs

Display “- - -’’, related value will

Period: 25secs

Numeric Blinking

Digital alarm

wink, refers to chapter 5.1.

Blinking, Red

Frequency 0.625Hz

Blinking, Yellow

Light alarm

Frequency 2Hz

Frequency 0. 5Hz

Event Record the event, such as the date, time, parameters, etc.

■Alarm Object：

z Physiological alarm: Indicate patient’s physiological parameters exceed limits. z Technical alarm: Indicate system failure to lead wrong results, i.e., sensor off. z Normal alarm: In normal range, no harm to patients’ health, .i.e. Battery low voltage.

A.11 Factory default value of alarm parameter

Default value of alarm high

Default value of alarm low

Alarm parameter(unit)

limit

A-2

limit

Appendix A

Adult Pediatric Neonate Adult Pediatric Neonate

EtCO2（mmHg）

RR（BPM）

SpO2（%）

PR（BPM）

60 60 60 0 0 0

150 150 150 3 12 12

100 95 95 85 80 80

100 200 200 55 100 100

A.12 Setting range and allowable tolerance of alarm high/low limits

Alarm parameter Setting range of alarm high

limit

SpO2

EtCO2

21%～100% 20%～99%

35 bpm～250 bpm 30 bpm～245bpm

5～100mmHg 0～99mmHg

1～150bpm 0～149bpm

Default value of alarm low

limit

A.13 Continuous operation time

Power supply: Internal 4xAA alkaline or Ni-MH battery or external wall-power. Capable of charging

when connect to external wall-power or power stack. Be capable of charging Ni-MH batteries only.

(DO NOT to charging alkaline batteries).

Internal power continuous operation time:SpO

≥ 10h，SpO2 & CO2 ≥ 3.5h.

A.14 Trend data storage

■ Store time of trend data:

Total 99 patients’ ID，72h trend data per ID

■ Store parameters of trend data:

Include SpO

, Pulse Rate, EtCO2, Respiration Rate, time etc.

A.15 Dimensions and weight

Model Dimensions（mm）L*W*H Net weight（kg） Gross weight（kg）

Host 125x73x23 0.137

Wireless USB

Dongle

Charger adapter

61.8x18.2x9.0

95x57x32 0.260 -

0.0075 -

0.233（with batteries）

A.16 Packing, transportation, storage

■Packing

Place the monitor in a plastic bag, place it in a corrugated carton filled with the foam or other

fillers. Seal the carton.

■Transportation

A-3

Appendix A

The monitor can be transported by airplane, train or automobile. Prevent fierce collision

during transportation. Do not keep it with perishables. The transportation environment

should be:

a)Environment temperature range: -20℃～＋70℃;

b) Relative humidity range: ≤95%; c) Air pressure range: 500hPa～1060hPa.

■Storage

The monitor should be stored indoors with a temperature range: -10 ~+40 , relative ℃℃

humidity≤80%, no corrosive gas, and with good ventilation.

A.17 Explanations of interface

Connector type Description

Wireless（PC end） Connected PC via wireless USB dongle（2.440GHz ISM band）

Wireless(handheld end） Built-in RF IC to communicate with wireless USB Dongle，with data rate up

to 40kbps.（2.440GHz ISM band）

DB9 SpO2 Connector Standard DB9-F Connector

DB9 CO2 Connector Standard DB9-F Connector

A.18 Compliance standards

CE Applied Standard of NT1D

Requirement CE(MDD 93/42/EEC)

General Safety

EMC conformity

R&TTE(99/5/EC)

EN 60601-1:1990+A1:1993

+A2:1995+A13：1996

EN 60601-2-49:2001 Particular requirements for the safety of multifunction Patient

EN60601-1-2:2001

ETSI EN 301 489-1

1.6.1(2008-04)

Medical electrical equipment-Part1: General requirements for

basic safety and essential performance

monitoring equipment

Medical equipment-Part1-2: General requirements for

safety-Collateral standard: Electromagnetic

compatibility-Requirements and tests

Electromagnetic compatibility and Radio spectrum Matters

(ERM); ElectroMagnetic Compatibility (EMC) standard for

radio equipment and services; Part 1: Common technical

requirements

A-4

Appendix A

ETSI EN 301 489-17

V1.3.2(2008-04)

ETSI EN 300 328 V1.7.1(2006-10)

Software validation

IEC 60601-1-4:2000

requirement

Usability

IEC 60601-1-6:2007

requirement

larm conformity IEC60601-1-8:2005

Spo2 Particular

EN ISO9919:2005

standard

Electromagnetic compatibility

and Radio spectrum Matters (ERM);

ElectroMagnetic Compatibility (EMC)

standard for radio equipment;

Part 17: Specific conditions for 2,4 GHz

wideband transmission systems,

5 GHz high performance RLAN equipment and

5,8 GHz Broadband Data Transmitting Systems

Electromagnetic compatibility

and Radio spectrum Matters (ERM);

Wideband transmission systems;

Data transmission equipment operating

in the 2,4 GHz ISM band and

using wide band modulation techniques;

Harmonized EN covering essential requirements

under article 3.2 of the R&TTE Directive

General requirements for safety Collateral Standard:

Programmable electrical medical systems

Medical electrical equipment Part 1-6: general requirements for basic safety and essential performance collateral standard: usability

Medical electrical equipment－Part 1-8：General requirements for safety-Collateral Standard：General requirements，tests and guidance for alarm systems in medical electrical equipment and medical systems in medical electrical equipment and medical electrical systems Medical electrical equipment－Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use

CO2 Particular

standard

Biological

compatible

requirement

EN ISO 21647:2004/AC:2006

Medical electrical equipment — Particular

requirements for the basic safety and

essential performance of respiratory gas

monitors

ISO 10993-1: 2003 Biological evaluation of medical devices part-1:Evaluation and

testing ISO 10993-1

ISO 10993-5:1999 Biological evaluation of medical devices –test for in vitro

cytotoxicity

A-5

Appendix A

ISO 10993-10:2002 Biological evaluation of medical devices – tests for irritation and

delayed-type hypersensitivity

Risk management

requirement

Label and symbol EN:980：2003

Information

supplied by the

manufacturer

Clinical

requirement

ISO 14971:2007

EN 1041:1998

EN ISO 14155-1:2003 Clinical investigation of medical devices for human subjects

EN ISO 14155-2:2003

Guidance of clinical evaluation

Meddev 2.7.1

Medical devices－Application of risk management to medical devices

Graphical symbols for use in the label of medical devices

Information supplied by the manufacturer with medical devices

–General requirements

Clinical investigation of medical devices for human subjects

–Clinical investigation plans

Evaluation of clinical data: a guide for manufacturers and

notified bodies

A-6

Appendix B

Appendix B: EMC (Electro-Magnetic Compatibility)

Caution: The monitor complys with the limits for medical devices to IEC601-1-2: 1993, EN60601-1-2:

1994, Medical Device Directive 93/42/EEC, and this monitor has been tested for CISPR 11 class A.

Guidance and manufacturer’s declaration-electromagnetic emissions-

for all EQUIPMENT and SYSTEMS

Guidance and manufacturer’s declaration-electromagnetic emission

The NT1D is intended for use in the electromagnetic environment specified below. The customer of the user of NT1D should assure that it is used in such environment.

Emission test Compliance Electromagnetic

environment-guidance

RF emissions

CISPR 11

Group 1 The NT1D 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.

RF emission CISPR 11

Class A

The NT1D is suitable for use in all

establishments other than domestic,

and those directly connected to a low

voltage power supply network which

supplies buildings used for domestic

purposes.

Guidance and manufacture’s declaration-electromagnetic immunity –

for all EQUIPMENT and SYSTEMS

Guidance and manufacturer’s declaration-electromagnetic immunity

The NT1D is intended for use in the electromagnetic environment specified below. The customer or the user of NT1D should assure that it is used in such an environment.

Immunity test

Electrostatic

discharge(ESD)

IEC 61000-4-2

IEC 60601 test

level

±6 kV contact

±8 kV air

Compliance level

±6 kV contact

±8 kV air

Electromagnetic

environment-guidance

Floors should be wood,

concrete or ceramic tile.

If floor are covered with

synthetic material, the

relative humidity should

be at least 30%.

Power frequency

(50Hz) magnetic

field IEC 61000-4-8

3A/m 3A/m Power frequency

magnetic fields should

be at levels

characteristic of a

B-1

Appendix B

typical location in a

typical commercial or

hospital environment.

Guidance and manufacturer’s declaration-electromagnetic immunity-

for EQUIPMENT and SYSTEMS that are not LIFE-SUPPORTING

Guidance and manufacturer’s declaration-electromagnetic immunity

The NT1D is intended for use in the electromagnetic environment specified below. The customer or the user of NT1D should assure that it is used in such an environment.

Immunity test IEC 60601 test level

Conducted RF

IEC 61000-4-6

Radiated RF

IEC 61000-4-3

3 Vrms

150 kHz to 80 MHz

3 V/m

80 MHz to 2.5 GHz

Compliance

level

3 Vrms

3 V/m

Electromagnetic environment

– guidance

Portable and mobile RF communications equipment should be used no closer to any

part of the NT1D. Including

cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.

Recommended separation distance

5.3

⎤

⎡

d =

⎢ ⎣

⎡

d =

⎢ ⎣

MHz

⎡

d =

⎢ ⎣

GHz Where p is the maximum output

power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in metres (m). Field strengths from fixed RF transmitter as determined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol:

⎥

⎦

5.3

⎤

80 MHz to 800

⎥

⎦

⎤

P 800 MHz to 2.5

⎥

17E

⎦

B-2

Appendix B

NOTE 1 At 80 MHz. the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. a Field strengths from fixed transmitters, such as base stations for radio(cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters. An electromagnetic site survey should be

considered. If the measured field strength in the location in which the NT1D is used exceeds the applicable RF compliance level above, the monitor should be observed to

verify normal operation. If abnormal performance is observed, additional measures may be

necessary, such as reorienting or relocating the NT1D.

b Over the frequency range 150 kHz to 80MHz. Field strengths should be less than 3

V/m.

Recommended separation distances between portable and mobile RF

RF communications equipment and the EQUIPMENT or SYSTEM-

For EQUIPMENT or SYSTEM that are not LIFE-SUPPORTING

Recommended separation distances between

Portable and mobile RF communications equipment and the monitor

The monitor is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the NT1D can help prevent

electromagnetic interference by maintaining a minimum distance between portable and

mobile RF communications equipment (transmitters) and the NT1D as recommended

below according to the maximum output power of the communications equipment.

Separation distance according to frequency of transmitter

d =

(m)

⎡ ⎢

⎣

800 MHz to 2.5

GHz

d =

⎡ ⎢

⎣

5.3

⎤ ⎥

⎦

Rated maximum

output power of

transmitter

(W)

0.01 0.12 0.12 0.23

0.1 0.37 0.37 0.74

1 1.17 1.17 2.33

10 3.69 3.69 7.38

100 11.67 11.67 23.33

150 kHz to 80 MHz

5.3

⎤

⎡

d =

⎢ ⎣

⎥

⎦

80 MHz to 800 MHZ

⎤

⎥

17E

⎦

B-3

Appendix B

For transmitters rated at a maximum output power not listed above, the recommended

separation distance d in metres (m) can be estimated using the equation 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.

NOTE1 At 80 MHz and 800 MHz, the separation distance for the higher frequency

range applies.

NOTE2 These guidelines may not apply in all situations. Electromagnetic propagation

is affected by absorption and reflection from structures, objects and people.

These limits are designed to provide reasonable protection against harmful interference in a typical medical installation. However, because of the proliferation of radio-frequency transmitting equipment and other sources of electrical noise in the health-care and home environments (for example, cellular phones, mobile two-way radios, electrical appliances), it is possible that high levels of such interference due to close proximity or strength of a source, may result in disruption of performance of this device.

The monitor generates, uses, and can radiate radio frequency energy and, if not installed and used in accordance with these instructions, may cause harmful interference with other devices in the vicinity. Disruption may be evidenced by erratic readings, cessation of operation, or other incorrect functioning .If this occurs, the site of use should be surveyed to determine the source of this disruption, and actions taken to eliminate the source:

● Turn equipment in the vicinity off and on to isolate the offending equipment

● Reorient or relocate the other receiving device

● Increase the separation between the interfering equipment and this equipment

B-4

Newtech USB1, NT1D Usr manual

Specifications and Main Features

Frequently Asked Questions

User Manual