A320 User Manual April 2016

WARNING: Do not modify this equipment without authorisation of the manufacturer. WARNING: If this equipment is modified, appropriate inspection and testing must be conducted to ensure continued safe use of equipment. CAUTION: Keep the operating environment free of dust, vibrations, corrosive, or flammable materials, and extremes of temperature and humidity. CAUTION: 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. CAUTION: Never use sharp or pointed objects to operate the frontpanel switches. CAUTION: The batteries must be taken out from the battery compartment if the device will not be used for more than 12 months. CAUTION: The device should only be used if the battery cover is closed. CAUTION: The batteries must be properly disposed of according to local regulation after their use. CAUTION: The device should be kept away from children & pets to avoid swallowing.

2

1.3 Definitions and Symbols Symbol

Description Type BF Equipment Batch code# Date of manufacture#

SN

Serial No.# Information of manufacture, including name and address Temperature limitation When the end-user wishes to discard this product, it must be sent to separate collection facilities for recovery and recycling Follow instruction for use

IPX4 Warning Caution Note #

Anti-dust & Anti-water class 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 The important information you should know

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

Section 2

Introduction 2 .1 General This chapter provides a general description of the Pulse Oximeter including a brief device description and product features.

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 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-exercise. Pre/post-operative conditions. Monitoring respiratory conditions. 2.3 Product Features 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. CAUTION: The device cannot be used in children less than 1 year old as the result may not be accurate.

CAUTION: 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. ^ Plethysmograph: 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).

Section 3

Installation, Setup and Operation 3.1. Description of the Front Panel (as figure 3.1.1)

Figure 3.1.1 Parts of front & back panel Table 3.1.1 Part Name and Description Item

Name

1

Power Button

Turn on/off the machine

2

Direction Button (M)

Direction change & parameter setting within the menu

3

Battery Compartment Compartment for batteries

4

OLED Panel

Description

Displays the SPO2/PR data & Plethysmograph

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

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

(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. 3.3.4.1. 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.

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. 3.3.4.2. 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 word on appears. 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 word off appears. 3.3.4.3. 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.

Figure 3.3.2 Figure 3.3.1 Note: 1.The alarm sound has a 1 second delay after an incorrect result is detected.

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. Note: 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. CAUTION: Do not use strong solvent. e.g acetone. CAUTION: Never use an abrasive such as steel wool or metal polish. CAUTION: Do not allow any liquid into the product, and do not immerse any parts of the device into any liquids. CAUTION: Avoid pouring liquid on the device while cleaning. CAUTION: Do not leave any cleaning solution on the surface of the device.

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. 5.2 Troubleshooting Table 5.2.1 Troubleshooting Problems Oxygen saturation or pulse rate is reading abnormally.

Oxygen saturation or pulse rate is unstable

Possible Reason

Resolutions

1. Finger is not placed correctly.

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

2. Patient's perfusion is too low to be measured.

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

1. Finger is not placed correctly.

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

2. Finger is trembling 2. Ensure patient is not or patient is moving. moving during measurement.

Problems

Possible Reason

Resolutions

1. Finger is not placed correctly.

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

1. There maybe inadequate power left in the batteries. 2. Batteries may have been installed incorrectly.

1. Please replace batteries.

3. The Pulse Oximeter may be damaged.

3. Please contact local customer service center.

Oxygen saturation or pulse rate is abnormal and caused alarm to 2. Patient's SpO2 & PR 2. Please consult healthcare sound. is abnormal. professional.

Pulse Oximeter does not turn on.

The device automatically turns off.

2. Please re-install the batteries.

1. The product is 1. This is normal. automatically powered off when no signal is detected longer than approx. 10-15 seconds. 2. There maybe inadequate power left in the batteries.

2. Please replace the batteries.

Section 6

Specifications Pulse Oximeter Specifications: Physical Characteristics Machine Dimensions : 37mm (W)× 74mm (D) × 38mm (H) Weight : approx: 50g(including 2×AAA battery）

Retail package Dimensions:90mm (W) × 120mm (D) × 67mm (H) Gross Weight: 175g Classifications:： 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^ ^ IPX4 means shell of this product can withstand the water from any direction dropping to the surface.

Power Internal

2x AAA 1.5V alkaline battery

Power Consumption

Less than 30mA(Normal)

Operation Environmental Condition: Operating Temperature Relative Humidity Air Pressure Operating Altitude

5°C to 40°C 15% to 80% non-condensing 86kPa-106kPa 0-2000 m

Transportation and Storage Environmental Condition: Storage Temperature

-10°C to 50°C

Relative Humidity

10% to 80% non-condensing

Air Pressure Operating Altitude

60kPa-106kPa 0-2000 m

Alarm default value Parameter

Value

Oxygen Saturation

Upper limit: 100 / Lower limit: 90

Pulse Rate

Upper limit: 130 / Lower limit: 50

Probe LED Specification Wave Length RED

660±2 nm

Radiant Power 1.8 mW

Infra RED

905±2 nm

2.0 mW

Electronics Parameters Parameter

Value

Oxygen Saturation Display

35-100%

Pulse Rate Display

30-250 BPM Oxygen Saturation

Resolution Measure Accuracy

Pulse Rate Oxygen Saturation Pulse Rate

1% 1 BPM ±2% (70%-100%) unspecified(≤70%) ±2 BPM

user in regards to

,

Customer Service

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 purchase. 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.