Boxym B-820 mini User Manual

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Mini Handheld Pulse Oximeter

User’s Manual

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Mini Handheld Pulse Oximeter

Disclaimer Statement

The company does not in any form guarantee the errors in this manual, installation errors and operator

errors, and does not assume any legal liability for incidental or consequential damages.

The contents contained in this manual are protected by the copyright law. All rights are reserved, and

without prior written permission of the company, any part of this manual can not be reproduced,

photographed, copied, or translated into other languages.

The company only considers to be responsible for the reliability, security and performance of the

instrument under the following circumstances, namely assembly operation, expansion, readjustment,

performance improvement and repair, all of which are performed by the personnel or institutions

authorized by the company; relevant electrical devices are in line with national standards; the instrument

is operated in accordance with the guidance in this manual.

The contents of this manual may be changed without notice.

Before using the product, please read the contents of this manual carefully for proper use of the product.

Please keep this manual after reading it, so as to access at any time when needed.

Foreword

This manual describes in detail the purpose, function and operational use of the product. Before using

this product, please carefully read and understand the contents of this manual to ensure proper use of

this product can be, and to ensure that the patient and operator safety.

The manual introduces this product according to the most complete configuration, so some contents

may not apply to your purchased product. If you have any questions, please contact with the company.

Please place this manual near the product, so as to be able to convenient and timely access when needed.

Applicable objects

This instrument is suitable for home users or professional clinical staffs, and users shall read the manual

carefully before using this instrument.

Illustrations

All illustrations in this manual are provided only for reference, and settings or data in the illustrations may

not be entirely consistent with the actual display you see on the product.

Warranty and maintenance services

Scope of Free Services:

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Mini Handheld Pulse Oximeter

Any device in compliance with the range of the company's warranty service can enjoy free services.

Scope of Paid Services:

(1) The company will implement the paid services for any device beyond the range of the company’s

warranty service;

(2) Even during the warranty period, the product needs to be repaired due to the following reasons:

human damage; grid voltage exceeding the specified range of device; irresistible natural disasters.

The company is irresponsible for the direct, indirect or final damage and delay caused by under the

following circumstances (including but not limited to):

Component disassembly, stretching and re-commissioning; replacement of accessories without

permission of the company or the machine repair by non-authorized personnel of the company.

Return of goods

Return process

The company is really necessary to be returned, follow these steps:

1. The acquired right of return. Contact our customer service department, informing of the product serial

number; if the serial number is non-legible, the return of goods will not be accepted. Please specify the

product model, serial number, and brief reason for return.

2. Freight: The device is shipped to the company for maintenance, and meanwhile users have to bear

the shipping cost (including customs fees).

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Contents

Chapter I Overview

....................................................................................................................................................

1.1 Safety Information

...............................................................................................................................................

1.1.1 Warning

..............................................................................................................................................

1.1.2 Caution

...............................................................................................................................................

1.1.3 Attention

.............................................................................................................................................

1.2 Symbol and Description

.....................................................................................................................................

Chapter II Product Overview

....................................................................................................................................

2.1 Introduction

...................................................................................................................................................

2.1.1 Intended use

.....................................................................................................................................

2.1.2 Environmental Requirements

........................................................................................................

2.1.3 Contraindications

.............................................................................................................................

2.2 Appearance

..................................................................................................................................................

2.2.1 Front View

.........................................................................................................................................

2.2.2 Rear view

.........................................................................................................................................

2.3 Screen Display

...........................................................................................................................................

2.3.1 SpO2 Parameter Area

...................................................................................................................

2.3.2 PR parameter area

........................................................................................................................

Chapter III Preparation before Use

.......................................................................................................................

3.1 Unpacking and Inspection

.......................................................................................................................

3.2 Power On

....................................................................................................................................................

3.3Shutdown

.....................................................................................................................................................

Chapter Ⅳ Menu Settings

......................................................................................................................................

4.1 Alarm

............................................................................................................................................................

4.1.1 SPO2 Alarm

....................................................................................................................................

4.1.2 Temp Alarm

.....................................................................................................................................

4.2Setup

............................................................................................................................................................

4.3System Setup

..............................................................................................................................................

4.3.1 Screen Brightness

.........................................................................................................................

4.3.2 Default Setup

...............................................................................................................................

4.3.3 Manufacturer Maintenance

..........................................................................................................

Chapter V Alarm

.......................................................................................................................................................

5.1 Alarm Type

..................................................................................................................................................

5.2 Alarm Status Icon

......................................................................................................................................

5.3 Alarm Pause

...............................................................................................................................................

5.4 Set Alarm Sound

........................................................................................................................................

5.5 Countermeasures to The Alarm

..............................................................................................................

Chapter Ⅵ SpO2

...................................................................................................................................................

6.1 Overview

..................................................................................................................................................

6.2 Safety Information

.....................................................................................................................................

6.3 Caring Stepsbin

.........................................................................................................................................

6.4 On/ Off Parameter Alarm

..........................................................................................................................

6.5 Set Alarm Limits

.........................................................................................................................................

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6.6 Measuring Influence Factors

...................................................................................................................

Chapter VII of temperature (TEMP) (optional)

....................................................................................................

7.1 Temperature Monitoring Operation Steps

.............................................................................................

7.2 Safety Information

.....................................................................................................................................

7.3 On / Off Parameters Alarm

......................................................................................................................

7.4 Set the Alarm Limit

....................................................................................................................................

7.5 Setting The Temperature Unit

.................................................................................................................

Chapter VIII Battery

.................................................................................................................................................

8.1 Overview

.....................................................................................................................................................

8.2 Installing The Batteries

.............................................................................................................................

8.3 Battery Recycling

.......................................................................................................................................

9.1 Inspection

....................................................................................................................................................

9.2 Cleaning

......................................................................................................................................................

9.3 Disinfection

.................................................................................................................................................

9.4 Scrap

...........................................................................................................................................................

Chapter Ⅹ Accessories

...........................................................................................................................................

A Product Specification

...........................................................................................................................................

B Default factory settings

........................................................................................................................................

C Alarm Information

.................................................................................................................................................

C.1 Physiological alarm information

.............................................................................................................

C.2 Technical alarm information

....................................................................................................................

D Manufacturer’s Declaration of the EUT

............................................................................................................

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Chapter I Overview

1.1 Safety Information

Warning

Tip ： potentially dangers or unsafe operations, and if they are not

avoided, it could result in death or serious personal injury or property

damage.

Caution

Tip ： potentially dangers or unsafe operations, and if they are not

avoided, it could result in slight personal injury, product failure, damage

or property loss.

Attention

Highlight important considerations, and provide instructions or

explanations to make better use of this product.

This product is not involved in the information on danger level.

1.1.1 Warning

Warning



Users before using this Palm Pulse Oximeter should follow the

instructions set out in this manual; or else, any incorrect operation

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may result in serious injury. The company will assume no warranty

for improper use of this device.



The device is used in the medical field, and measurement results

serve only as reference.

 Before use, users must check the device, cables and accessories to

ensure that they can properly work safely.

 The device is not available in the presence of flammable gases or

other flammable anesthetic gases, in order to avoid explosion.



Do not open the housing of the oximeter, to avoid the risk of electric

shock. If necessary, please the company's staff maintain.

 The oximeter is suitable for the occasions where an electrosurgical

device is used; where it shares with an electrosurgical device, the

user (doctor or nurse) should ensure the safety of the patient under

intensive care.



During defibrillation, do not touch patients; or else, it may cause

serious injury and death.

 To prevent delays in treatment, make full alarm settings for each

patient, while alarm sound should also be able to be ensured when

alarming.

 The physiological waveforms, physiological parameters and alarm

information and others displayed by the device are for doctor’s

reference, but can not be directly used as the basis for clinical

treatment.



Note to place the power line and all cables to avoid the hazard of

strangling patients or tripping other personnel.

 To avoid personal injury, in addition to qualified technicians, other

persons can not repair the device.

1.1.2 Caution

Caution

 To ensure patient safety, please use the accessories designated by

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the company.

 When the product and accessories described in this manual are

about to exceed the period of use, they must be treated in

accordance with relevant product specifications. If you want to learn

more information, please contact the company or its representative

bodies.

 Do not use a mobile phone near the oximeter, because the mobile

phone will generate too strong radiation field, which thus interferes

with the oximeter function.

 Before the device is powered on, make sure that the voltage and

frequency of the power supply are in line with the requirements

specified on the device label or in this manual.

 Please properly install or carry the device to prevent the device

falling or being damaged due to collision, receiving strong shock or

other mechanical force.

1.1.3 Attention

Attention

 Mount the device at the place where it is easy to observe, operate and

maintain.



Place this manual near the device so as to be able to easily and

timely access when needed.

 Before use, verify and correct and ensure that the device is working

properly.

 If a liquid is spilled into the enclosure of the device, disconnect the

power supply immediately, and contact the maintenance personnel at

once.

 The manual introduces the product according to the most complete

configuration, and the product you purchase may not have some of

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the configurations or functions.

 Remove nail polish or artificial nails before oxygen probes are used.

Nail polish or artificial nails may cause inaccurate oximetry readings.

1.2 Symbol and Description

Symbol

Description

Symbol

Description

BF type applied part

Refer to operation manual

Cautions, please refer to attached

documents

IP22

Level of protecting against liquid

inlet

Manufacturer

Date of manufacture

Serial number

Recycled separately from other

household waste under the

WEEE directive

Keep dry

Keep away from sunlight

Chapter II Product Overview

2.1 Introduction

2.1.1 Intended use

The oximeter is suitable for both home care and hospital use to monitor patients’ vital sign

parameters, including blood oxygen saturation, pulse rate and body temperature (body

temperature is optional) .Palm Pulse Oximeter is a novel, compact and easy-to-carry

device. This device can be used in Emergency Room, home care and other occasions.

2.1.2 Environmental Requirements

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Temperature

Operating temperature 5(C)～40(C)

Transportation and storage temperature -20(C)～ 50(C)

Humidity

Operating humidity 15%～ 85%

Transportation and storage humidity ≤ 90 %

Atmospheric pressure

86.0kPa～106.0kPa；

Altitude

Working altitude -500 ～ 4,600m (-1,600 ～ 15,000

ft)

Transportation and storage altitude -500 ～ 13,100m (-1,600 ～

43,000 ft)

The operating environment of this device must comply with the requirements of the

environment specification in this manual.

When the device is moved from one scene to another one, due to differences temperature

or humidity, which may cause the device condensation. At this point, you must keep

waiting until the condensation condition disappears to use the device.

Warning

 Please ensure that the device is operated under specified

environmental conditions; otherwise, it will not meet the technical

specification claimed in this manual, and may lead to unpredictable

consequences, which may bring damages to the device.

Attention

 The oximeter can be used in hospitals, emergency room and

ambulance, as well as for home care.

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2.1.3 Contraindications

None

2.2 Appearance

2.2.1 Front View

1. Display screen

 2.4-inch color LCD display screen

2. Power switch: In different situations, the key has different functions.

 Start: After the battery is installed, short press the button to turn on the monitor.

 Shutdown: in the startup state, long press the button for 2 seconds to turn off the

monitor.

3. Menu key

 Press this key to enter the menu screen or select an option.

4. Alarm Indicator light

235

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 Yellow and normally on

5. Up key

In different situations, the key has a different function. Press this key to move the

cursor upward, to increase the value of a menu option or to increase the pulse volume

and to complete other operations. The key also has an alarm pause function.

6. Down key

In different situations, the key has different functions. Press this key to move the cursor

upward, to reduce the value of a menu option or to decrease the pulse volume and to

complete other operations.

7. Micro USB interface

 Connect the adapter

8. Oxygen sensor socket

 connects with the oxygen saturation probes to achieve oxygen

detection.

9. Temperature sensor interface

 Connected to the temperature probes to achieve temperature measurement.

10. Power indicator



Green: Connecting the AC power adapter, the oximeter being powered.

 Off: the oximeter is not connected to AC

2.2.2 Rear view

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1. Speaker

2. Battery cover

2.3 Screen Display

The following diagram shows the screen display interface.

1. Waveform area: Shows plethysmography (Pleth) waveform

2. SpO2 value display area

3. PR value display area

4. Physiological and technical alarms area

Display alarm information, tips and information on the operating mode.

Circle display when coming with multiple messages.

5. Alarm status area: indicates the alarm sound turned off.

6. Battery status icon

7. PI bar diagram

8. Time area

2.3.1 SpO2 value display Area

1 2

687

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1. Value Name

2. SpO2 value

3. PI bar graph

4. Low alarm limit

5. High alarm limit

6. Unit

2.3.2 PR parameter area

1. Value Name

2. Unit

3. High alarm limit

4. Low alarm limit

5. PR value

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Chapter III Preparation before Use

3.1 Unpacking and Inspection

Take out the oximeter and accessories from the box carefully, and store the packaging in

case of future shipping or other use. Check the accessories according to the packing list.

If any damage happened, please contact our company’s after-sales department or agency

immediately.

Warning



Keep packaging material out of children’s reach. Concerning Disposal

packaging materials, waste disposal system must comply with relevant local

regulations or hospital’s claim.

3.2 Power On

1. Before starting, check whether the oximeter is mechanically damaged.

2. Make sure the battery has enough capacity.

3. Insert the oximeter cable into interface jack.

4. Press the power switch, and enter the boot screen.

5. Enter into the main interface after the boot screen disappearance.

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Warning



If find any function damage of oximeter, or get an error promotion, stop using

this oximeter anymore. And contact the biomedical engineer in hospital or

company’s maintenance engineer.

3.3Shutdown

Please refer to the following steps to turn off the oximeter:

1. Confirm that the work of monitoring patient comes to an end.

2. Disconnect the oximeter and oximeter cable.

3. Press the power switch and hold for two seconds to turn off the oximeter.

Chapter Ⅳ Menu Settings

The oximeter is designed with a flexible configuration. Both monitoring and alarm setting

could be free performed by user. Press the Menu key to bring up the main menu shown in

Figure 4-1.

Figure 4-1

4.1 Alarm

Select "ALARM" in the main menu, and pop out a menu as shown in Figure 4-2:

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Figure 4-2

4.1.1 SPO2 Alarm

Choose SpO2 in Alarm menu

 SPO2 adjustable range: Max: 100, Min:70



SPO2 Alarm：On/Off



Adjustment method：

Moving cursor via pressing 【 ▲ ,▼】, Choosing item as your need, then press【M 】 ,

Increase or decrease via pressing【▲ ,▼】. After your adjustment, pressing 【M】to

ensure it.

4.1.2 PR Alarm

Choose PR in Alarm menu

 PR adjustable range: Max: 254, Min: 0



SPO2 Alarm：On/Off

 Adjustment method same as 4.1.1

4.1.2 Temp Alarm (optional)

Choose Temp in Alarm menu

 Temp adjustable range: Max: 50, Min: 20



SPO2 Alarm：On/Off

 Adjustment method same as 4.1.1

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4.2 Setup

In the main menu, select [Setup], set up menu appears as Figure 4-3 below. In the

settings menu there are [Pulse Vol] , [Alarm Vol] and [TEMP Unit].

Figure 4-3

Users can modify the pulse and alarm volume, Temp unit as needed.

 Choose【Brightness】in【SETUP】, adjusting via pressing 【▲,▼】. Options have

nice levels as “1”,“2”,“3”,“4”,“5”,“6”,“7”,“8”,“9”.

 In the [Setup] menu, select the [alarm vol], Press【▲ ,▼】 to select the level of the

alarm volume . The options have five levels as "1", "2", "3" , "4", "5".

 In the [Setup] menu, select the [TEMP unit] ，Press【▲,▼】to modify TEMP unit. The

options include “℃”and“℉”

Attention

 If used outdoors or ambient light, please increase the screen brightness for

observation

 Use Alarm Off button if you need to turn off the Alarm function.

4.3 System Setup

Select "SYSTEM" from the main menu, the system menu appears as shown in Figure

4-4. The 『System』 menu include [Review], [default ] and [Return] three options.

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Figure 4-4

4.3.1 Review Choose【Review】in【SYSTEM】, you will see menu as Figure 4-5. You can setup record Open or Close, and the recording period (Time) in【Review】menu.

图4-5 历史回顾

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Choose【Trend】in【Review】, you will see menu as Figure 4-6.

图4-6 Trend

This device can review 500groups history data.

Choose【Previous Page】in【Trend】, you will see menu as Figure 4-7.

图4-7 Review

You can choose SPO2, PR, TEMP in【Review Open】read.

【PRE】to read the previous page

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【NEXT】to read the next page

4.3.2 Default Setup

In the system menu, selecting Default will pop up the "Recover factory set" dialog box,

as shown in Figure 4-8.

Figure 4-8

Select 【Yes】 to recover factory set.

Select 【No】 to quit the current operation, and the system remains unchanged original

configuration.

4.3.3 Manufacturer Maintenance

In the [System Setup], select the [Maintenance] item, and pop out a dialog box, as shown

in Figure 4-9.

Users can input specific user password to active advanced settings in user maintenance

menu.

“Factory Maintenance” function only opens to the company's designated maintenance

personnel.

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Figure 4-9

4.4 Time Setup

Choose【Time Set】in【SETUP】, menu as Figure 4-10.

Figure 4-10

Attention

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When exiting the [manufacturer maintenance], it will return to the

sub-dialog box [Setup] menu; besides, all dialog boxes will exit to the

[main menu].

Chapter V Alarm

Alarm refers to tips made by the monitor to medical staff through sound, light and other means when abnormal vital signs change is observed, or patients cannot be monitored smoothly due to the failure of the monitor oximeter itself.

5.1 Alarm Type

Alarm can be classified into two categories which are physiological alarm and technical alarm. When the alarm comes from the changes in the patient's vital signs, namely, the physiological parameters of the patient being under care exceed a specific range or the patient’s physiological abnormalities cannot be attribute to one single physiological parameter beyond the range, it can be referred to as physiological alarm; when the alarm is from the machine itself, namely, when there are technical barriers existed in the alarm or the machine itself breaks down, as a result, the patient cannot be observed accurately, it is referred to as technical alarm.

Patient or machine

Alarm category

Heart rate of the patient is 114BPM, beyond the

range of heart rate alarm which is set by the user.

Physiological alarm

SpO2 measurement module fails

Technical alarm

 Physiological alarm: the alarm light is normally on and the parameters on

the screen will flash with sound alarms accompanied.

 Technical alarm: the alarm light is normally on with sound alarms

accompanied.

5.2 Alarm Status Icon

Besides the alarm types mentioned above, the following alarm icons will

appear on the screen which means different alarm states.

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: the state when alarm tone stops.

: the state when alarm turns off.

5.3 Alarm Pause

Press the

【▲】

button, the alarm tone can be paused:

 The alarm is suspended while the alarm light and alarm information

continue display.

 The state bar on the screen shows the left time of the alarm tone.

 The state bar on the screen shows icon.

5.4 Set Alarm Sound

Select the【Menu】→【Setup】→【Alarm Volume】→ adjust the volume (Max 5, Min 1). After the oximeter is turned off and restarted, the minimum alarm volume set will not change.

Warning

 When the alarm volume is adjusted to 0, the alarm sound is off.

 Patients cannot be monitored and cared only by the sound alarm

system. When the alarm sound is adjust to a relatively small volume,

patients can be in a dangerous condition. Users should pay close

attention to the actual clinical condition of patients.

5.5 Countermeasures to The Alarm

In case that the oximeter sends out an alarm, please refer to the following steps to take appropriate measures:

1. Check the patient's condition.

2. Verify that the parameters of the ongoing alarm or the types of alarm.

3. Identify the reasons of the alarm.

4. Remove the reasons of the alarm.

5. Check whether the alarm is eliminated.

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For the specific treatment measures for each alarm, please refer to Appendix

C Alarm information.

Chapter

Ⅵ

SpO2

6.1 Overview

A continuous and non-invasive pulsation oximeter quantitative method is adopted for

SpO2 measurement. It measures the specific wavelength of light from the light source of

oxygen saturation probes, and after it is absorbed by oxyhemoglobin in the patient’s tissue

and reaches the luminous flux of photodetector end, thus to get oxygen saturation and

pulse rate. The oximeter has been calibrated and is used to display functional oxygen

saturation. The interface is as shown in Figure 7-1

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1 2

568

Figure 7- 1 SpO2 measurement interface

Measurements provide:

1. Arterial oxygen saturation (SpO2): the percentage of oxyhemoglobin in the total

hemoglobin.

2. Perfusion bar graph: proportional to the intensity of pulse.

3. Pulse rate (PR): the number of pulse detected per minute (obtained from

plethysmography waveform).

4. Plethysmography (Pleth) waveform: the strength of the patient’s pulse signal does not

affect the amplitude of Pleth waveform.

6.2 Safety Information

Warning

 Influence from carboxyhemoglobin, methemoglobin or dye dilution

chemicals will cause biased SPO2 value.

 Do not use any other SpO2 probe except the specified model in this

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manual, as well ensure that all operations are under the instruction of

the manual. Observe all warnings and precautions.

 Before starting to monitor and care, firstly check whether the oxygen

probe is normal. If the oxygen probe packaging or the probe has

been damaged, do not use this oxygen probe.

 If a patient has a tendency to hypoxia, the oximeter should be used to

analyze the oxygen probe, because the induced current may cause

serious burns of the patient.

 When the patient is under continuous long-term monitoring, finger

position in the oxygen probe should be checked once every two

hours, meanwhile move patient’s hand every 4 hours or when a

change occurred to patient’s skin. Continuous long-term monitoring

may increase risk of patient’s unpredictable skin changes, such as

allergies, reddening, blistering or oppression necrosis.

 The cables of electrosurgical devices cannot be entwined with

oximeter cable.

 Do not mount and place the oxygen probe on the limbs with arterial

ducts or intravenous tubes.

 Do not place the oxygen probe and blood pressure cuff on the same

limb.

 For the patients younger than one-year-old, do not use the device

when the ambient temperature above 40 degrees Celsius to avoid

burning baby’s skin.



If the sensor packaging or sensor has been damaged, do not use this

Sp02sensor, and it should be returned to the manufacturer.

6.3 Caring Stepsbin

1. Select the appropriate oxygen probe according to the patient’s type and weight.

2. Clean the measurement site, such as colored nail polish.

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3. Place the oxygen probe at the measurement site.

4. Connect the oximeter and oximeter cable.

6.4 On/ Off Parameter Alarm

1. Select the [Menu] → [alarm]→[SPO2 alarm]

2. Set SPO2 or PR alarm to:

[On]: When the measured parameter has alarm event, the machine will have alarm

indication;

[Off]: No alarm indication when the menu is seted to off. Alarm sound, light and

indication to be closed at the same time. There will be a sign in the SPO2 or PR

parameter area.

6.5 Set Alarm Limits

1. Select the [Menu] → [alarm]→[SPO2 alarm]

2. Set the [High Limit] of SpO2 or PR: When the measured parameter value is above the

high alarm limit, a physiological alarm of too high parameters will be triggered.

3. Set the [Low Limit] of SpO2 or PR: When the measured parameter value is below the

low alarm limit, a physiological alarm of too low parameters will be triggered.

In case that a parameter alarm occurs, the measured value of the parameter will flash and

the appropriate alarm light will be triggered.

6.6 Measuring Influence Factors

If the accuracy of the measurement results is suspected, first use other methods to

examine the patient's vital signs, and then test the oximeter and oxygen probe. In the

measurement process, the following factors may affect the accuracy of measurements:

 Outside light radiation

 Body movement (active or passive patient movement)

 Diagnostic test

 Weak perfusion

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 Electromagnetic field effects, such as nuclear magnetic

resonance device

 Electrosurgical devices

 Concentration of non-functional hemoglobin, such as carboxyhemoglobin (COHb)

and methemoglobin (MetHb)

 Presence of certain dyes, such as methylene blue and indigo rouge, inappropriate

placement of oxygen probe or incorrect use of oxygen probe

 Shock, anemia, low temperature or application of vasoconstrictor drugs leads to

reduced pulse blood flow in the water that can not be measured

Chapter VII of temperature (TEMP) (optional)

7.1 Temperature Monitoring Operation Steps (Optional)

Oximeter temperature probe can be used to measure the body temperature

data.

1. If you are using a disposable temperature probe, insert the cable’s right side

into socket and connect the other side with probe. For reusable temperature

probe, you can plug it directly into the socket.

2. The temperature probe firmly attached to the patient.

3. Connect the oximeter and temperature cable.

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Temperature measurement interface shown in Figure 8-1.

Figure 8-1 temperature measurement interface

7.2 Safety Information

Warning

 Should be tested before the start of the measurement probe cable is

normal. Unplug the temperature probe cable from the jack, the screen will

display the error message "T sensor off" and an alarm sounds. Similar to

other channels.

 Place carefully temperature probe and cable when not in use, probe and

cable should be rolled into a loose ring. If the inside of the wire pull too

tight, it will cause mechanical damage.

 Must biennial temperature measuring instrument calibration (or according

to hospital protocol indicates the time).

Note

Disposable temperature probe can only be used once. To protect the environment, disposable temperature probe should be recycled or properly

Temperature measurements

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disposed of.

 During the measurement temperature measurement function self-test

automatically once per hour. Self-Test for 2 seconds, will not affect the

normal operation of the oximeter.

7.3 On / Off Parameters Alarm

1. Select【Menu】→【Alarm】→【Alarm temperature alarm】

2. Set the 【Alarm Temp】as follows:

【Open】：When this parameter alarm occurs, the oximeter will

alarm-related parameters;

【Off】：oximeter without alarm-related parameters, alarm sounds, alarm

lights and alarms are turned off, the display Temp parameter shows “ ”

icon.

7.4 Set the Alarm Limit

1. Select【Menu】→【Alarm】→【Alarm temperature alarm

】

2. Set Temp The【High Limit】：When the measured parameter value is above the high alarm limit, an alarm will be triggered physiological parameters too high.

3. Set Temp the【Lower limit】：When the measured value is below the low alarm limit parameters, low physiological parameters will trigger an alarm. When a parameter alarm occurs, This value will flash and corresponding trigger an alarm lamp.

7.5 Setting The Temperature Unit

Select【Menu】→【Settings】→【TEMP unit】，options are "℃" and "℉"

Page 33

Chapter VIII Battery

8.1 Overview

The oximeter main power supplied is alkaline batteries. Icon in the top right corner of the screen shows the battery status of the batteries. When the battery is too low to display, you must replace the batteries or use the AC adapter for power, after a period of time. Otherwise, oximeter will automatically shut down. In the case of measuring the patient cannot be interrupted, you can oximeter with the adapter and AC power.

Note

Remove the batteries before shipping oximeter or not use for a long time.

AC adapter power supply is available simultaneous use when you are using

batteries.

Warning

Keep out of the reach of children. Use only the battery specified by the manufacturer.

8.2 Installing The Batteries

1. Hold the battery cover, push it down, remove the battery cover.

2. Install the batteries:

1) Press the batteries correct polarity into the batteries compartment;

2) The batteries cover on the top of the batteries, push up, install the battery

cover.

Be careful

Do not use different types of alkaline batteries.

Note

Battery run time depends on the device configuration and operation.

Page 34

8.3 Battery Recycling

If the battery is visibly damaged, or if the battery runs out of energy, should be

replaced, and properly recycled. When disposing of used batteries, should follow the

appropriate regulations.

Warning

Do not remove the battery, put it into a fire or short circuit. Battery burn,

explode or leak may cause personal injury.

Chapter Ⅸ Maintenance and Cleaning

Please merely use the materials and methods listed in this section for cleaning or

disinfecting of the device. The company does not provide any guarantee for damage or

accidents caused by other materials or methods.

The company does not bear any responsibility for the effectiveness of the chemicals or

methods listed as a means of infection control. About the method for infection control,

please consult the hospital’s infection prevention department or epidemiologist.

Please keep your devices and its’ accessories free of dust. To prevent damage to the

device, be sure to observe the following:



Please dilute the cleaning agent and disinfectant according to the manufacturer's

instructions, or use the lowest possible concentrations.



Do not immerse the device in the liquid.



Do not pour liquid onto the device or accessories.



Do not allow liquid to enter the enclosure.



Do not use abrasive materials (such as steel wool or silver polish), and any

strong solvents (such as acetone or acetone-containing cleaning agents).

Warning

Page 35



Before cleaning the device, you must turn off the power supply and disconnect

the power line and charger base.

Caution

 If you pour liquid onto the device or accessories due to incaution, please

contact the maintenance personnel or the company immediately.

Attention



To clean or disinfect reusable accessories, please refer to the manual provided

along with the accessories.

9.1 Inspection

Before the oximeter is used for the first time, and after it is repaired or upgraded, or at

least every two years, a comprehensive inspection on it should be conducted by qualified

maintenance personnel to ensure the normal operation and work of the oximeter.

Inspection items should include:

 The environment and power supply meet the requirements.

 The device and accessories are not mechanically damaged.

 The power line is not worn, with good insulation properties.

 Use the specified accessories.

 The alarm system functions properly.

 Battery performance.

 The monitoring function is in good working condition.

If you find any damage or unusual phenomenon, please do not use the oximeter, and

immediately contact the hospital's medical engineer or the company’s maintenance

personnel.

Page 36

9.2 Cleaning

The device should be cleaned on a regular basis, and the frequency of cleaning should be

increased in the areas suffering from serious environmental pollution or heavy sand.

Please consult or learn about the hospital’s regulations on the device cleaning before

cleaning.

The following cleaning agents are available for selection:

 Diluted soapy water and diluted ammonia

 Sodium hypochlorite (bleaching power for washing)

 Hydrogen peroxide (3%)

 Ethanol (70%)

 Isopropanol (70%)

When cleaning the device:

1. Turn off the oximeter.

2. Use a soft cotton ball and adsorb the right amount of cleaning agent, and wipe the

display screen.

3. Use a soft cloth ball and adsorb the right amount of cleaning agent, and wipe the

surface of the device.

4. Use a dry cloth to remove excessive cleaning agent when necessary.

5. The device is placed in the ventilated, shade and dry environment.

9.3 Disinfection

Disinfection operation may produce some degree of damage to the oximeter. It is

recommended to perform disinfection only when deemed necessary in your hospital

maintenance plan. The device should be cleaned before disinfection.

The recommended disinfectants are: 70% ethanol, 70% isopropyl alcohol and 2%

glutaraldehyde solution.

Caution

Page 37



Do not use gas (EtO) or formaldehyde for disinfection.

9.4 Scrap

To avoid contamination or infection to others, environment or other devices, before

scrapping the oximeter, follow the state relevant laws or regulations for its disinfection and

purification. For the oxygen probe, please follow the relevant provisions of the local

hospital on waste scrap

Page 38

Chapter

Ⅹ

Accessories

Warning

 Use only the accessories specified in this manual, and the use of

other accessories may damage the oximeter

 Disposable accessories can only be used once, because repeated

use can cause performance degradation or cross-infection.

 If accessory packages or accessories are damaged, do not use the

accessories.

 The blood oxygen saturation probe in the chapter complies with

biocompatibility requirements and meets the standards ISO 10993-1

and ISO 10993-5 and ISO 10993-10.

Blood oxygen saturation probe

Model

Applicabl

e object

Wavelength *

DB9 adult finger

clip

Adult

660nm 940nm

DB9 newborn wrap

Newborn

660 nm 905 nm

Others

Name

Model

Body temperature probe (optional)

Two core plastic plugs

Lithium battery

1.5V AAA

Page 39

A Product Specification

According to the classification standard of China's State Food and Drug Administration the

oximeter belongs to Class II device.

Safety specification (in accordance with IEC60601-1 classification)

Protection type of electric shock

Class II (including internal power supply)

Protection class of electric shock

BF (anti-defibrillator)

Explosion protection class

Ordinary device, explosion protection not provided

Protection class of inlet liquid

IPX2

Movement grade

Handheld

Working mode

Continuous

Environmental specification

Work

Storage

Temperature（℃）

0～40

-20～60

Relative humidity (non-condensing)

15％～95％

10％～95％

Atmospheric pressure (mmHg or

kPa)

425 ～ 809 mmHg or 70.0 ～

106.0 kPa

120 ～ 809mmHg or 22.0 ～

107.4 kPa

Alkaline battery

Page 40

Quantity

3 pcs

Standard

1.5V AAA

Supply time

6h, using the new and fully charged battery at the ambient

temperature 25℃, with a typical configuration (SpO2

continuous measurement, the backlight set to minimum

brightness, and the sound turned off all the time).

Shutdown delay

At most 10 minutes(since the first low battery capacity alarm)

Physical specification

W × H ×T

127×67×27 mm

Maximum weight

110g（net weight）

Hardware specification

Display screen

Color TFT, 2.4-inch, dot matrix: 240× 320

Speaker

1, alarm sound (45 ~ 85dB), multi-level volume function; alarm

sound in line with the requirements of IEC 60601-1-8 standard Alarm indicator light

1, yellow

Power indicator light

1, green

Blood oxygen probe interface

1, D 9-pin socket

Temperature probe interface

1 (optional)

Micro USB interface

1, connect adapter

Measurement specification

SpO2

Confirm the accuracy of measurements: the accuracy of SpO2 is already confirmed in human trials by

comparison with the reference value of arterial blood sample measured by CO- oxygen pressure

Page 41

gauge. The measurement results of pulsation oxygen meter meet statistical distribution, and compared

with the measurement results of CO- oxygen pressure gauge, only about two-thirds of the

measurement results is expected to be within the specified precision.

Measuring range

0～100％

Resolution

Precision

70～100％: ± 2% (adults, in the non-moving state)

± 3% (in the moving state)

0％～69％：not defined

Update cycle

1 s

Measuring range

18～300 bpm

Resolution

1 bpm

Precision

±3 bpm （in the non-moving state）

±5 bpm（in the moving state）

Update cycle

1 s

Alarm limit specification

Alarm limit

Range（％）

Step length（％）

SpO2 high limit

（low limit +1）～100

1 SpO2 low limit

50～（high limit -1）

Alarm limit

Range（bpm）

Step length（bpm）

PR high limit

（low limit +1）～300

1 PR low limit

18～（high limit -1）

Measurement specification

Page 42

TEMP

Measuring range

0~50 ℃

Resolution

0.1 ℃

Precision

±0.1 ℃ Alarm limit specification

Alarm limit

Range（℃）

Step length（％）

TEMP high limit

（low limit+1）～50

1 TEMP low limit

0～（high limit-1）

Page 43

B Default factory settings

This chapter lists some of the most important default factory settings of the oximeter. If

users can not change the factory settings, but when needed, the default factory settings of

the oximeter can be restored.

B.1 Alarm

Alarm setting

Default factory settings

Alarm volume *

Pause time for alarm tone

120 s

Alarm switch

open

Probe off

low

SPO2 alarm

open

PR alarm limit

open

B.2 SpO2

SpO2 Settings

Adults

SpO2 high alarm limit

100

SpO2 PR low alarm limit

Page 44

PR Settings

Adults

PR high alarm limit

120

PR low alarm limit

Temp setting

adults

Temp high alarm limit

38.0

Temp ow alarm limit

35.5

C Alarm Information

This chapter lists some of the most important physiological and technical alarm

information, but some alarm information is not necessarily listed.

For each alarm information, appropriate countermeasures are given out. If the problem

persists after operations following the countermeasures, contact the maintenance

personnel.

Alarm information

Reasons and countermeasures

SpO2 too high

Check the physiological condition of the patient, and confirm whether the SpO2 too low

Page 45

C.1 Physiological alarm information

C.2 Technical alarm information

Alarm information

Reasons and countermeasures

probe off

If the oxygen probe is off from the patient or host, if it fails, or an oxygen

probe not specified in this manual is used, check whether the oxygen

probe type and installation position are correct, and whether the oxygen

probe is damaged. Reconnect the oxygen probe or use a new oxygen

probe.

patient type and alarm limit settings are applied to the patient.

PR too high

PR too low

No pulse found If the patient's pulse signal is too weak, the system can not analyze.

Check the patient's condition, oxygen probe and measurement site. Temp too high

Check the physiological condition of the patient, and confirm whether the

patient type and alarm limit settings are applied to the patient.

Temp too low

Page 46

Inadequate battery

capacity

When the low battery voltage is below the alarm voltage, if the battery in

use is alkaline battery, replace the battery immediately. If the battery in

use is a lithium battery, connect the charger base and AC power supply to

recharge the lithium battery, and then use the battery to supply power as

needed.

D Manufacturer’s Declaration of the EUT

Guidance and manufacturer´s declaration – electromagnetic emission –

for all EQUIPMENT AND SYSTEMS

Guidance and manufacturer´s declaration – electromagnetic emission

The Palm Pulse Oximeter is intended for use in the electromagnetic environment specified below.

The customer or the user of Palm Pulse Oximeter should assure that it is used in such an

environment.

Emissions test

Compliance

Electromagnetic environment - guidance

RF emissions

CISPR 11

Group 1

The Palm Pulse Oximeter 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 emissions

CISPR 11

Class B

The Palm Pulse Oximeter is suitable for use in all establi

shments, including domestic establishments and those dir

ectly connected to the public low-voltage power supply ne

twork that supplies buildings used for domestic purposes.

Harmonic

emissions

IEC 61000-3-2

N/A

Voltage fluctuations

/flicker emissions

IEC 61000-3-3

N/A

Guidance and manufacturer's declaration – electromagnetic immunity –

for all EQUIPMENT and SYSTEMS

Page 47

Guidance and manufacturer´s declaration – electromagnetic immunity

The Palm Pulse Oximeter is intended for use in the electromagnetic environment specified below. The

customer or the user of the Palm Pulse Oximeter should assure that it is used in such an environment.

Immunity test

EN 60601

test level

Compliance level

Electromagnetic environment -

guidance

Electrostatic

discharge (ESD)

IEC 61000-4-2

± 6 kV contact

± 8 kV air

± 6 kV contact

± 8 kV air

Floors should be wood, concrete or

ceramic tile. If floors are covered

with synthetic material, the relative

humidity should be at least 30 %.

Electrostatic

transient / burst

IEC 61000-4-4

± 2 kV for power

supply lines

±1 kV for input/output

lines

N/A

Mains power quality should be that

of a typical commercial or hospital

environment.

Surge

IEC 61000-4-5

± 1 kV differential

mode

± 2 kV common

mode

N/A

Mains power quality should be that

of a typical commercial or hospital

environment.

Voltage dips,

short

interruptions and

voltage

variations

on power supply

input lines

IEC 61000-4-11

< 5 % U

(>95 % dip in UT)

for 0.5 cycle

40 % U

(60 % dip in UT)

for 5 cycles

70 % U

(30 % dip in UT)

for 25 cycles

< 5 % U

(>95 % dip in UT)

for 5 sec

N/A

Mains power quality should be that

of a typical commercial or hospital

environment. If the user of the

Palm Pulse Oximeter requires

continued operation during power

mains interruptions, it is

recommended that the Palm Pulse

Oximeter be powered from an

uninterruptible power supply or a

battery.

Power

frequency

(50/60 Hz)

magnetic field

IEC 61000-4-8

3 A/m

Power frequency magnetic fields

should be at levels characteristic of

a typical location in a typical

commercial or hospital

environment.

NOTE UTis the a. c. mains voltage prior to application of the test level.

Page 48

Guidance and manufacturer´s declaration – electromagnetic immunity –

for EQUIPMENT and SYSTEM that are not LIFE-SUPPORTING

Guidance and manufacturer´s declaration – electromagnetic immunity

The Palm Pulse Oximeter is intended for use in the electromagnetic environment specified below. The

customer or the user of the Palm Pulse Oximeter should assure that it is used in such an environment.

Immunity test

EN 60601 test

level

Compliance

level

Electromagnetic environment - guidance

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

N/A

3 V/m

Portable and mobile RF communications

equipment should be used no closer to any

part of the Palm Pulse Oximeter including

cables, than the recommended separation

distance calculated from the equation

applicable to the frequency of the transmitter.

Recommended separation distance

d ]

5.3

[1

d ]

5.3

[1

80 MHz to 800 MHz

d ]7[1

800 MHz to 2.5 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 transmitters, as

determined by an electromagnetic site

survey,ashould be less than the compliance

level in each frequency range.

Interference may occur in the vicinity of

equipment marked with the following symbol:

NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.

NOTE 2 These guidelines may not apply in all situations. Electromagnetic is affected by absorption and

reflection from structures, objects and people.

Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones

Page 49

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

Palm Pulse Oximeter is used exceeds the applicable RF compliance level above, the Palm Pulse Oximeter

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

may be necessary, such as reorienting or relocating the Palm Pulse Oximeter.

b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3V/m.

Recommended separation distances between portable and mobile

RF communications equipment and the EQUIPMENT or SYSTEM -

for EQUIPMENT and SYSTEMS that are not LIFE-SUPPORTING

Recommended separation distances between

portable and mobile RF communications equipment and the Palm Pulse Oximeter

The Palm Pulse Oximeter is intended for use in an electromagnetic environment in which radiated RF

disturbances are controlled. The customer or the user of the Palm Pulse Oximeter can help prevent

electromagnetic interference by maintaining a minimum distance between portable and mobile RF

communications equipment (transmitters) and the Palm Pulse Oximeter as recommended below,

according to the maximum output power of the communications equipment

Separation distance according to frequency of transmitter

Rated maximum

output of

transmitter

150 kHz to 80 MHz

d ]

5.3

[1

80 MHz to 800 MHz

d ]

5.3

[1

800 MHz to 2.5 GHz

d ]7[1

0.01/0.12

0.23

0.1/0.38

0.73

1/1.2

2.3

10/3.8

7.3

100/12

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.

NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.

NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by

absorption and reflection from structures, objects and people.