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Heart Sure A320 User Manual

Made by: Heart Sure
Type: User Manual
Category: Medical Equipment
Pages: 20
Size: 2.60 MB


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Section 1


1.1 Instructions for the Safe Operation and Use of the Pulse Oximeter 


Do not use the Pulse Oximeter 

in a flammable atmosphere where concentrations of flammable 
products exist.


 Do not throw batteries in fire as this may cause them to



Do not attempt to recharge normal dry-cell batteries as 

they may leak, cause a fire or explode.


Do not use the Pulse Oximeter in an MRI or CT 


1.2 Warnings 


Do not attempt to service the Pulse Oximeter yourself. Only qualified 
service personnel should attempt any necessary internal servicing.
Prolonged use or depending on the patient's condition may require 
changing the sensor site periodically. Change sensor site and check skin 
integrity, circulatory status and correct alignment at least every 2 hours.
SpO2 measurements may be adversely affected in the presence of high 
ambient light. Shield the sensor area if necessary. 
The following will cause interference to the testing accuracy of the  
Pulse Oximeter:
  High-frequency electrosurgical equipment.   
  Placement of the sensor on an extremity with a blood pressure cuff,  
  arterial catheter, or intravascular line.   
  Patients with hypotension, severe vasoconstriction, severe anaemia or 
  The patient is in cardiac arrest or is in shock.      
  Fingernail polish or false fingernails may cause inaccurate SpO2 


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 Keep the operating environment free of dust, vibrations, 

corrosive, or flammable materials, and extremes of temperature and 


Do not operate the unit if it is damp or wet. Avoid using 

the equipment immediately after moving it from a cold environment to 
a warm, humid location.


 Never use sharp or pointed objects to operate the front-

panel switches.


The batteries must be taken out from the battery compart-

ment if the device will not be used for more than 12 months.


The device should only be used if the battery cover is 



 The batteries must be properly disposed of according to 

local regulation after their use.


The device should be kept away from children & pets to 

avoid swallowing.


If this equipment is modified, appropriate inspection and 

testing must be conducted to ensure continued safe use of equipment.


 Do not modify this equipment without authorisation of the 




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Batch code, Date of manufacturer and Serial No. are printed on the label on the 
battery cover

Section 2


2 .1 General

     This chapter provides a general description of the Pulse Oximeter 
including a brief device description and product features.

1.3  Definitions and Symbols



When the end-user wishes to discard this product, it must 
be sent to separate collection facilities for recovery and 

Temperature limitation

Serial No.





Information of manufacture, including name and address


Anti-dust & Anti-water class


The important information you should know 

The information you should know to protect patients and 
medical staff from possible injury
The information you should know to protect the equipment 
from possible damage

Date of manufacture




Type BF Equipment



Batch code




Follow instruction for use




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2.2  Brief Device Description


     The Pulse Oximeter is intended for non-invasive spot-check 
measurements of functional oxygen saturation of arterial haemoglobin 
(SpO2). The advanced DSP algorithm


 can minimize the influence of 

motion and improve measurement accuracy of low perfusion




 The device cannot be used in children less than 1 year 

old as the result may not be accurate.

            Measures oxygen saturation (SpO2) and pulse rate (PR).
            Lightweight & portable. 
            Easy to use. 
            Manually adjust the direction of interface (6 display modes).
            Dual colour OLED display, simultaneous display for testing value 
            and plethysmograph^ . 
            Low perfusion: 0.2%.
            Anti-shaking technology.
            Visual & sound alarm function. 
            Real-time spot-checks.
            Low battery voltage indicator.
            Automatic switch off.
            Standard 2x AAA 1.5V Alkaline batteries will provide more than 20 
            hours continuous output.

2.3 Product Features

     The Pulse Oximeter can be used to measure human oxygen saturation 
and pulse rate through the finger. The product is suitable for use by 
individuals and healthcare professionals in multiple situations, including; 
home, clinical & sporting environments. For example:




Pre/post-operative conditions.


Monitoring respiratory conditions.


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Section 3

Installation, Setup and Operation

Figure 3.1.1 

Parts of front & back panel

Table 3.1.1 Part Name and Description

3.1. Description of the Front Panel (as figure 3.1.1)








Power Button

Turn on/off the machine

Direction Button 


Battery Compartment
OLED Panel

Direction change & parameter setting within 

the menu
Compartment for batteries
Displays the SPO2/PR data & Plethysmograph


The fingertip Pulse Oximeter is intended only as an 

adjunct in patient assessment. It must be used in conjunction with 

other methods of assessing clinical signs and symptoms.

2.3.1 ^ Defintions



DSP algorithm: 

Digital signal processor algorithm.



Low perfusion: 

In physiology, perfusion is the process of a body 

delivering blood to a capillary bed in its biological tissue. Under the 

condition of low perfusion, the measurement of non-invasive saturation 

of pulse-blood oxygen can be low.




Instrument for measuring changes in volume 

within an organ or whole body (usually resulting from fluctuations in 

the amount of blood or air it contains).


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3.2.1 Display Modes

The OLED display can rotate four directions with six different display 
modes when pressing the direction button (M) as shown below:  

3.3  Operation
3.3.1   Install battery

Remove cover & install 2 x AAA batteries into the battery cassette in 
correct polarities and place cover back on.

3.3.2  Turn the Pulse Oximeter On

Press the power button for 2 seconds to turn the Pulse Oximeter on. Open 
the clamp, then place one finger into rubber hole of the Pulse Oximeter 

3.2 Display

After being switched on, the OLED display is as follows: 


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(it is best to put the finger as far in as possible) with nail surface upward, 
then release the clamp to shut.

3.3.3. Read data on the display screen

The data may take a few seconds to appear while a reading is obtained. 
Only your Healthcare Professional can interpret your individual readings.

3.3.4.   Parameter Settings

In the parameter settings menu you can set high/ low alarm values for both 
SpO2 and PR, as well as turning sound on/off.  To access the parameter 
settings hold down the (M) button for one second. 
There are two types of submenus; Alarm Setup and Sounds Setup. To 
switch between the setups, ensure the * is next to the word Sounds Setup 
or Alm Setup, then press (M) for one second to switch between menus, 
as per figures 3.3.1 and 3.3.2. Sounds Setup

Hold down the (M) button for one second to bring up the sound menu as 
per figure 3.3.1. Press (M) quickly to move down the menu. 

To increase parameter values

Press (M) quickly to move down the menu until your * signal appears next 
to the + / - sign. Then hold down (M) for one second until the + sign 
appears. This will now increase the value of any parameter in this menu. 
Quickly press (M) to move to the parameter value you wish to change. 
Once you have reached the parameter value you want to change, hold 
down (M) for one second and you will see the value increase. Once you've 
reached your desired level, release the (M) button. 


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To decrease parameter values

Press (M) quickly to move down the menu until your * signal appears next 
to the + / - sign. Then hold down (M) for one second until the - sign 
appears. This will now decrease the value of any parameter in this menu. 
Quickly press (M) to move to the parameter value you wish to change. 
Once you have reached the parameter value you want to change, hold 
down (M) for one second and you will see the value decrease. Once 
you've reached your desired level, release the (M) button. Alarm Setup

Hold down the (M) button for one second to bring up alarm menu as per 
figure 3.3.2. Press (M) quickly to move down the menu. 

To turn Alarm or Beep ON

Press (M) quickly to move down the menu until your * signal appears next 
to the word ALM or Beep. Then hold down (M) for one second until the 



To turn Alarm or Beep OFF

Press (M) quickly to move down the menu until your * signal appears next 
to the word ALM or Beep. Then hold down (M) for one second until the 


 appears. To Exit Parameter Settings Menu

Press (M) quickly to move down the menu until your * signal appears next 
to the word Exit. Then hold down (M) for one second to exit menu. 


1.The alarm sound has a 1 second delay after an incorrect result 

is detected. 

 Figure 3.3.1

 Figure 3.3.2


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1. When the battery power is at lowest level, the battery indicator 

symbol  "      " appears, indicating replacement of battery is required.
2. The plethysmograph can been regarded as correct if the wave is 
fluctuating constantly.

Section 4

Cleaning and Disinfection

4.1 Cleaning & Disinfection 

Switch off the power and take out the batteries before cleaning. Keep 
the surface of the device clean and free of dust and dirt. Clean the 
surface (OLED display screen included) of the unit with a soft dry 
cloth. Disinfect the machine if being used in a clinical setting or by 
multiple users. To disinfect, use a small amount of 70-75% density 
medical alcohol on a soft dry cloth to avoid alcohol permeating into 
the device.



Do not leave any cleaning solution on the surface of the 



 Do not allow any liquid into the product, and do not 

immerse any parts of the device into any liquids.


Never use an abrasive such as steel wool or metal polish. 

3.4.4  Turn the Pulse Oximeter Off

Press & hold the power button for 2 seconds. Alternatively the device 
will automatically shut off after approximately 10-15 seconds.


Do not use strong solvent. e.g acetone. 


Avoid pouring liquid on the device while cleaning. 


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Section 5

Troubleshooting and Maintenance

5.1 Maintenance


Replace the batteries when the battery indicator symbol is low.


Clean/disinfect surface of thе Pulse Oximeter before use.


Remove the batteries inside the battery cassette if the Pulse Oximeter  

    will not be operated for more than 12 months.


Store the product in a place where ambient temperature is -10 to 50


    and humidity is 15% to 80%.


Regularly inspect the device to make sure that no obvious damage 

    exists that will effect the safety and performance of device.

1. Finger is not 
    placed correctly.

2. Finger is trembling 
    or patient is moving.

Oxygen saturation or 
pulse rate is unstable

1. Retry by placing the finger 
    in the correct position as 
    per instructions. 

2. Ensure patient is not 
    moving during 


Possible Reason


2. Patient's perfusion 
    is too low to be 

1. Finger is not placed 

Oxygen saturation or 
pulse rate is reading 

1. Retry by placing the finger 
    in the correct position as 
    per instructions.

2. Retry the measurement, if 
    still reading abnormally, 
    please consult healthcare 

5.2 Troubleshooting 



Table 5.2.1 Troubleshooting


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Section 6


Pulse Oximeter Specifications:
Physical Characteristics

Dimensions : 37mm (W)× 74mm 



× 38mm (H)

Weight : approx: 50g


including 2×AAA battery


Possible Reason


1. Finger is not placed 

1. Retry by placing the finger 
    in the correct position as 
    per instructions.

Oxygen saturation or 
pulse rate is abnormal 
and caused alarm to 

2. Patient's SpO


 & PR

    is abnormal.

2. Please consult healthcare 

Pulse Oximeter 
does not turn on.

1. There maybe  
    inadequate power 
    left in the batteries. 

3. The Pulse Oximeter 
    may be damaged.

2. Batteries may have 
    been installed 

3. Please contact local
    customer service center.

2. Please re-install the 

1. Please replace batteries. 

1. The product is 
    powered off when 
    no signal is detected 
    longer than approx. 
    10-15 seconds.

2. Please replace the batteries.

1. This is normal.

The device 
turns off. 

2. There maybe 
    inadequate  power   
    left in the batteries.


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Retail package 



90mm (W) × 120mm (D) × 67mm (H)

Gross Weight: 175g


Anti-electric Shock Type: Internally powered equipment
Anti-electric Shock Degree: Type BF equipment
EMC: Type B class IMode of operation: Continuous Operation 
Enclosure Degree of ingress protection: IPX4






means shell of this product can withstand the water from any 

direction dropping to the surface.

Operating Temperature

5°C to 40°C 

Relative Humidity 

15% to 80% non-condensing

Air Pressure


0-2000 m


2x AAA 1.5V alkaline battery   

Less than 30mA(Normal)


Power Consumption

Operating Altitude

Operation Environmental Condition: 

Storage Temperature

-10°C to 50°C 

Relative Humidity 

10% to 80% non-condensing

Air Pressure


0-2000 m

Operating Altitude

Transportation and Storage Environmental Condition: 


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Alarm default value


Oxygen Saturation

Pulse Rate


Upper limit: 100 / Lower limit: 90

Upper limit: 130 / Lower limit: 50

Electronics Parameters


Oxygen Saturation Display 

Pulse Rate Display


Oxygen Saturation

Pulse Rate

Measure Accuracy

Oxygen Saturation

Pulse Rate


30-250 BPM



±2  BPM

Probe LED Specification


Infra RED

Radiant Power

Wave Length

660±2 nm

905±2 nm

1.8 mW

2.0 mW

±2% (70%-100%)




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Should   repair  be  needed  within  the  warranty 
period, enclose the tear off  section of this 
warranty card and your proof of purchase receipt. 
Please ensure all


relevant details are completed  

before sending your unit in for service.  Please 
ensure your contact details are current and 
include a brief description of the problem you are 
experiencing together with your proof of 
Include the unit with all product


components in 

your package. This is


extremely important, as it 

will assist our repair technicians in making the 
correct diagnosis of any problems. 


in regards to 


Customer Service


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J.A.Davey Pty Ltd- Heart Sure Repairs


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