Gima OXY 110 User manual

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Gima S.p.A.

Via Marconi, 1 - 20060 Gessate (MI) Italy gima@gimaitaly.com - export@gimaitaly.com

PROFESSIONAL MEDICAL PRODUCTS

www.gimaitaly.com

PULSOXIMETRO OXY 110 OXY 110 PULSE OXIMETER PULSIOXÍMETRO OXY 110 OXYMÈTRE DE POULS OXY 110

Manuale d’uso - User manual Manuel de l’utilisateur - Guía de uso

ATTENZIONE: Gli operatori devono leggere e capire completamente questo manuale prima di utilizzare il prodotto. ATTENTION: The operators must carefully read and completely understand the present manual before using the product. AVIS: Les opérateurs doivent lire et bien comprendre ce manuel avant d’utiliser le produit. ATENCIÓN: Los operadores tienen que leer y entender completamente este manual antes de utilizar el producto.

M34341-M-Rev.2.02.20

34341 / SP-20

Shenzhen Creative Industry Co., Ltd.

Floor 5, BLD 9, BaiWangxin High-Tech Industrial Park, Songbai Road, Xili Street, Nanshan District, 518110 Shenzhen, P.R. China Made in China

Shanghai International Holding Corp. GmbH (Europe) Eiffestrasse 80, 20537, Hamburg, Germany

0123

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Table of Contents

1 Overview ...................................................................................................... 40

1.1 Appearance ............................................................................................40

1.2 Product Name and Model ......................................................................42

1.3 Structure ................................................................................................. 42

1.4 Features .................................................................................................. 42

1.5 Intended Use ..........................................................................................42

1.6 Working Environment ..............................................................................42

2 Power Supply .............................................................................................. 43

3 Make Measurement .................................................................................... 45

3.1

SpO2 Measurement ......................................................................................45

3.2 Temperature Measurement (optional) .................................................... 46

4 Operation ..................................................................................................... 47

4.1 Power on/off the Oximeter......................................................................47

4.2 Default Display Screen ...........................................................................48

4.3 Menu ....................................................................................................... 49

4.4 Record ................................................................................................... 58

5 Technical Specications ............................................................................ 61

6 Over-limit Indication ...................................................................................63

6.1 Limit settings ..........................................................................................63

6.2

Over-limit indication sound mute setting .......................................................63

7 Packing List ................................................................................................. 63

8 Repair and Maintenance ............................................................................ 64

8.1 Maintenance ........................................................................................... 64

8.2 Cleaning and Disinfecting Instruction ..................................................... 64

9 Troubleshooting .......................................................................................... 65

10 Frequently Asked Questions ...................................................................... 66

Appendix ..........................................................................................................67

I. Key of Symbols .......................................................................................... 67

II. Common Knowledge ................................................................................ 69

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1 Overview

1.1 Appearance

Display screen

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Alert indicator

Menu/Conrm

Auto-rotate /Up Power indicator

Power/Left

Figure 1.1 Front view

TEMP:

Temperature

probe

connector

Figure 1.2 Upper-side view

Figure 1.3 Bottom side view

Record/Back

Right /Sound

Setting/Down

SpO2: SpO2 probe connector

USB connector

DC power input contact shoes with polarity indication

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1. Display screen: Display measurement result, trends and menus.

2. (Power/Left): Power on/off the device by longtime pressing; On menu or

sub-menu screen, short time press it to move the cursor left or adjust the parameter values.

3. (Right/Sound): On data recall screen, longtime press this key, then the

delete dialog pops up; On measuring screen, longtime press it to disable or enable the global sound.

On measuring screen, if the global sound is enabled, and alert event occurs, then

short time press it to perform audible alert reset (that’s to say, to alert sound will be mute). When the current alert event ends or a new type of alert event occurs, then status of audible alert reset will be ended (that’s to say, the alert sound will be generated again when an alert event occurs). On menu or sub-menu screen, short time press it to move the cursor right or adjust the parameter values.

4. (Auto-rotate/Up): On measuring screen, longtime pressing to enable or dis-

able the automatic screen orientation (on horizontal or vertical direction); On menu or sub-menu screen, short time press it to move the cursor upwards or adjust the parameter value.

(Setting/Down): On measuring screen, longtime pressing to enter into set-

ting screen; On menu or sub-menu screen, short time press it to move the cursor downwards or adjust the parameter value.

6. (Menu/Conrm): Short time press it to enter into menu screen, or to con-

rm the selection.

7. (Record/Back): Short time press it to enter into

or to back to the previous level of menu.

8. (Alert indicator): If the probe is not well placed or disconnected,

or the measured value exceeds the preset alert limit value, then the alert indicator will ash with orange color.

9. (Power saving mode indicator) If the device is set as power saving mode,

then the indicator lights up. And on measuring screen, the indicator ashes with the pulse beep.

10. Icon: “SpO2”: ( ):

SpO2 Probe Connector.

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SpO2 record list screen,

11. Icon: “TEMP”: ( ): Temperature Probe Connector.

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12. ( ) USB connector. Used for data uploading or charging.

13. ( ): DC power input contact shoes with polarity indication. Used

for connecting external DC power input for charging the built-in rechargeable battery via the base.

1.2 Product Name and Model

Name: Handheld Pulse Oximeter Model: SP-20

1.3 Structure

It consists of the main unit and (Note: with optional temperature prob, this Oximeter can make temperature measurement.)

SpO2 probe.

1.4 Features

• It is lightweight, small in size and easy to carry.

• Color LCD to display plethysmogram and parameters.

• Measure

• PI (Perfusion Index) display is available.

• Up to 580 hours data storage for

• 16 user IDs for marking data and can be added.

• A built-on holder for convenient standing on desktop and display viewing.

• Real-time battery status display and low battery voltage indication.

• Auto power off is available.

• Audible and visual alert function is available.

• Data uploading to PC for management (Optional).

• Power saving mode is available.

SpO2, Pulse Rate and Temperature simultaneously.

SpO2 and PR and can be recalled.

1.5 Intended Use

This Handheld Pulse Oximeter is intended for measuring and recording the pulse rate, functional oxygen saturation ( detecting

SpO2, pulse rate and temperature of adult and neonate patients in clinical

institutions and homes.

SpO2) and temperature (optional). It is applicable for

1.6 Working Environment

Operating temperature: 5~40°C Operating humidity: 15%~93% (non-condensing) Atmospheric pressure: 70kPa~106kPa

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2 Power Supply

1. Internal power supply with built-in battery:

Built-in battery specication: 2000mAh lithium battery.

2. External power from the AC power adapter:

Use the AC power adapter provided by the manufacturer. Make sure the mains

power supply is 100-240VAC with 50/60Hz.

Note: it’s recommended to use the AC power adapter provided by the manufacturer.

3. The Base:

Input: Micro USB connector, 5VDC/1A Output: Contact pins. 5VDC/1A

Micro USB connector

Figure 2.1A Base--front view Figure 2.1B Base--top view

Description:

The base is used to hold the oximeter, and also for charging the oximeter. You can charge the oximeter by the following methods:

When the oximeter is held by the base, you can connect one end of the USB cable to the USB connector on the back of the base marked with “DC 5V/1A”, and the other end to the USB power source with output capacity of 5V DC/1A.

2) If the oximeter is not held by the base, then you can just connect one end of the USB cable to the USB connector on the device marked with “ ”, and the other end to the USB power source with output capacity of 5V DC/1A.

Notes:

1) During charging, if the oximeter is held by the base, please do not tilt the base backwards too much, or the USB cable and the USB connector may be damaged.

2) Put the device into the base properly, and pay attention to the polarity markings, as shown in gure 2.2.

Polarity markings

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Oximeter

Insert the oximeter

into the base by this

direction

Base

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Figure 2.2 Connection between oximeter and base

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3 Make Measurement

3.1

SpO2 Measurement

Operation procedures:

1. Connect the with “ the connector rmly and pull).

2. The red blinking light inside the clip of the nection.

3. Insert one nger (index nger is preferred, the nail should be not too long) into the clip of the probe according to the nger mark,as shown in gure 3.1.

4. The device will begin to take the measurement, and the measured result will be displayed on the screen, as shown in gure 4.2.

Figure 3.1 demonstration for SpO2 probe

Safety instructions for SpO2 measurement

 Long term use of the

pain, especially for those with microcirculatory problems. It is recommended that the probe should NOT be applied to the same place for over two hours, change the measurement site periodically and when necessary.

 When the ambient temperature is over 35℃, please change the measuring site every

two hours; when the ambient temperature is over 37℃, please do NOT use the sensor, as using in high temperatures can cause burns.

 Do NOT place the  Do NOT put the

blood pressure measurement may affect the

 The device is calibrated to display functional oxygen saturation  Do NOT allow the sensor cable to twist or bend.  Check the

sor.

 When the temperature of the

SpO2 probe to the connector on the upper-side of the device marked

SpO2”. (Note: When disconnecting the connector, be sure to hold the head of

SpO2 probe indicates a successful con-

SpO2 probe on the same place may result in discomfort or

SpO2

SpO2 probe on a nger with edema or fragile tissue.

SpO2 probe and pressure cuff on the same limb, otherwise the

SpO2 sensor and cable before use. Do NOT use a damaged

SpO2 sensor is abnormal, do not use it further.

SpO2 measurement.

SpO2 sen-

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 Remove nail polish or other cosmetic products from the ngernail.  The ngernail should be of normal length.  The

SpO2 sensor cannot be immersed into water, liquid or cleanser.

 The

SpO2 sensor can be repeatedly used. Please clean and disinfect before reuse.

 Connector with the label “

SpO2” can only be connected with

SpO2 probe, and connector with the label “TEMP” can only be connected with the temperature probe.

3.2 Temperature Measurement (optional)

The infrared temperature probe is a delicate transducer. To operate please follow these steps and procedures. Failure to accurately operate may cause damage to the probe.

The infrared temperature probe is as shown in gure 3.2.

Please place the infrared temperature probe in a stable ambient temperature for 30 minutes before taking a measurement.

Measuring tip of

temperature probe

Temperature

Probe Cover

Measuring key

Small screen

Power on/off key

Battery cover

Big display screen

Figure 3.2 the infrared temperature probe

Operation procedure:

1. Connect the infrared temperature probe to the connector on the upper side of device marked with “TEMP”.

2. When the screen shows as the big display screen in gure 3.2 and the temperature unit “°C” is blinking, the user can begin to take the measurement.

3. Insert the tip of the temperature probe into the earhole and press the measuring key to start the measurement. A short beep means the measurement has nished and the result will be displayed on the big display screen on temperature probe and the display screen of the Oximeter.

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Nota:

• If the temperature probe detects a hardware failure, the display screen on the infra-

red temperature probe will show “Err” and will not enter into measurement mode.

• The infrared temperature probe will switch to standby state automatically if there is

no operation for 1 minute. If a further measurement is needed, press the measuring key and repeat step 2 and step 3.

• Normal body temperature varies depending on the position/area the measurement

is taken from. The following table shows the varying temperature ranges of the different body positions.

Temperature varying range at different body positions:

Arm 34,7 ~ 37,3°C Oral 35,5 ~ 37,5°C Rectal 36,6 ~ 38,0°C Ear 35,8 ~ 38,0°C

Safety Instruction for Temperature Measurement

 Do NOT take a measurement when the patient is moving.  Patients with tympanitis or otitis problems should NOT use this device.  When the infrared temperature probe is connected to the device, the probe will

consequently be at power-on status, therefore pressing the power on/off key on the temperature probe will not cause any effect.

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4 Operation

4.1 Power on/off the Oximeter

• Long pressing “ ” Power/Left key for 1~2 seconds, then the oximeter will be

powered on. The oximeter will do self-test and then the software version and warning message “Professional attendance is required for continuous monitoring!” will be shown on the screen, as shown in gure 4.1 (refer to your oximeter for actual version).

Figura 4.1

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4.2 Default Display Screen

Press “ ” power key for 2 seconds to start up the Oximeter, then the screen will display the default screen, as shown in Figure 4.2.

Auto-rotate icon

Auto power off

disable icon

User ID

Patient type

SpO2 mark

SpO2 value

SpO2 high/low

limit setting

value

Pulse rate

mark and unit

HR high/low limit

setting value

Perfusion index

Current time

Figure 4.2A Default Display Screen---in vertical

Wireless icon Recording mode Sound indicator

Battery indicator

Pulse Strength bar-graph

Pulse symbol

Pulse rate value

TEMP value

Plethysmogram

Description:

• During measurement, if the nger is not inserted properly, or the probe is not con-

nected or the probe is off from the nger, then “Check Probe” message prompts and keeps blinking on the screen, and “bibibi...” alert sound appears simultaneously. Alert sound is sustaining for about 3 minutes, and if there is no any key operation in this period, then the device will power off automatically (if the auto power off function is enabled).

• During measurement, longtime pressing Auto-rotate/Up key “ ”, then

the Auto-rotate white icon “ ” appears on the upper right corner of the

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screen, it means the auto rotation function is enabled, if you place this oximeter horizontally, then the display shows in horizontal, as shown in gure 4.2B.

Figure 4.2B Default Display Screen---in horizontal

•

Sound indicator “ ” means that the global sound is disabled, the user can enable

the global sound by longtime pressing “ ”. key. Longtime pressing “ ”

key again can disable the global sound, that’s to say, the speaker is turned off at all, therefore, no pulse beep sound, no audible alert and no key click sound.

• If the global sound is enabled by longtime pressing “ ”, key, then during the

measurement, over-limit alert event or probe off event can activate the audible alert. Refer to Section 6.2 for detailed alert indication sound.

• If the memory is full, the corresponding memory full icon appears on the screen:

“ ”, means temperature memory is full,“ ” means

memory is full; “ ”, means

SpO2 trend record memory is full. No display of the

SpO2 spot-check record

icon means the current corresponding storing space is not full. If the memory is full, the data storing will continue in such way the new record will overwrite the oldest record, so that it’s recommended to upload the stored data into the computer in time.

4.3 Menu

On the default measuring screen, short time press “ ” Menu/Conrm key for

entering into main menu screen (as shown in Figure 4.3).

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There are 9 functional icons in main menu screen, press Up/Down/Left/ Right key can move the cursor to make selection and press “

” Menu/Conrm key again to conrm the selection.

• User ID: Add new or edit the current

User ID.

• User: Select patient type, “Adult”

and “Neonate” for option.

Note: when the device is set to the neonate patient type, then the User icon

“ ”

turns to grey

“ ”, and the patient type on upper left corner turns to pink “ ”.

• Recording mode: Select the data

recording mode, “Spot-check Record” and “Trend Record” for option.

• SpO2 record: Recall and review the

records stored on the oximeter, two types of record for option: “Spotcheck Record” and “Trend Record”,

Figure 4.3 Main menu

see Section 4.4 for details.

• TEMP Record: Review the temper-

ature record list.

• Date: Set the time and date, see Section 4.3.6 for details.

• Settings: Set the system parameter, including brightness, sound volume, display

language, power saving mode etc., see Section 4.3.7 for details.

• Alerts: Set the low alert limit for

SpO2 and the high/low alert limit for PR, see Section

4.3.8 for details.

• Help: To view the tips information of

SpO2 measurement and temperature measure-

ment, see Section 4.3.9 for details.

4.3.1 User ID

On main menu screen, move the cursor on “User ID” and press Conrm key “ ”, then the oximeter enters into User ID Setup screen, as shown in gure 4.4.

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Figure 4.4A User ID setup screen

Move the cursor on “Edit” and press Conrm key “ ”; when the cursor turns to blue, then the user can edit the User ID, and move the cursor on “OK” to conrm the edit, the edit screen is as shown in gure 4.4B.

Figure 4.4B User ID edit screen

4.3.2 User

On main menu screen, move the cursor on “User” and press Conrm key “ ”, then the oximeter enters into Patient type Setup screen, as shown in gure 4.5.

Figure 4.5 Patient type setup screen

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4.3.3 Recording Mode

On main menu screen, move the cursor on “Recording Mode” and press Conrm key “ ”, then the oximeter enters into Recording Mode Setup screen, as shown in gure

4.6.

Figure 4.6 Recording mode setup screen

Note: When selecting “Spot-check Record” for data recording, the measuring time should last over 10 seconds to get one spot-check reading, or no reading value will not be recorded in Spot-check data record; When selecting “Trend Record”, the measuring time should exceed 30 seconds, or no one record will be recorded in Trend data record list.

4.3.4 SpO2 Record

On main menu screen, move the cursor on “ “ ”, then the oximeter enters into

SpO2 Record” and press Conrm key

SpO2 record review method selecting screen,

as shown in gure 4.7.

Figure 4.7 SpO2 record review method selecting screen

Refer to Section 4.4 for details.

4.3.5 TEMP Record

On main menu screen, move the cursor on “TEMP Record” and press Conrm key “ ”, then the oximeter enters into temperature record list screen, as shown in gure 4.8.

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Figure 4.8 TEMP record list screen

4.3.6 Date

On main menu screen, move the cursor on “Date” and press Conrm key “ ”, then the oximeter enters into date setup screen, as shown in gure 4.9.

Figure 4.9 Date setup screen

Date setting procedure:

1) Move the cursor stays on the Year of the date, press Conrm key “ ” to active

Year option, the cursor ashes on the Year of the date.

2) Press Up/Down key to adjust Year.

3) Press “ ” (Conrm) key to conrm and exit from date setting.

4) The procedures of adjusting Month, Day, Hour, Minute and Second value are the

same with Year adjustment.

Date Format: DD-YY-MM; Time Format: HH:MM:SS

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Note: The setting operations of other parameters (such as User ID, User, Auto Power Off, Power Saving etc.) are the same with date setting.

4.3.7 Settings

On main menu screen, move the cursor on “Settings” and press Conrm key “ ”, then the oximeter enters into system setting screen, as shown in gure 4.10.

Figura 4.10

System

setting screen

Description:

• Brightness: To set the brightness of backlight, 6 levels for optional, the factory

default is level 3, as shown in gure 4.10A.

• Volume: To set the sound volume (including alert sound, pulse beep sound and key

click sound), 6 levels sound volume for optional, the factory default is level 3, as shown in gure 4.10B.

• Pulse beep: To turn on/off pulse beep, the factory default is “On”, as shown in gure

4.10C. If the global sound is enables by longtime pressing , key, and the pulse

beep is set to “On” option, and when there is no over-limit event, then pulse beep sound can be heard during

SpO2 measurement.

• Language: This oximeter provides the display with two languages: English and Sim-

plied Chinese, the factory default is “English”, as shown in gure 4.10D.

• Auto power off: To turn on/off the Auto Power Off mode, the factory default is “On”,

as shown in gure 4.10E.

• Wireless: To turn on/off the wireless connection function, the factory default is “On”,

as shown in gure 4.10F.

• Power saving mode: To turn on/off the Power Saving mode, the factory default is

“On”, as shown in gure 4.10G.

• TEMP unit: To set the temperature unit, “°C (Celsius)” and “°F (Fahrenheit)” for

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option, the factory default is “°F”, as shown in gure 4.10H.

• Factory Default: Enter into the factory default setting, as shown in gure 4.10I.

• Version: For viewing version number of the software, as shown in gure 4.10J.

• Demo: Enter into the Demonstration mode, as shown in gure 4.10K.

Figure 4.10A Brightness setup Figure 4.10B Volume setup

Figure 4.10C Pulse beep setup Figure 4.10D Language setup

Figure 4.10E Auto Power OFF setup Figure 4.10F Wireless setup

Figure 4.10G Power Saving setup Figure 4.10I TEMP unit setup

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Figure 4.10H Version info Figure 4.10J Default setting

Notes:

• When the Auto Power Off is set to “On” option, if there is no key operation for 3 minutes, then the oximeter will power off automatically.

• When the Power Saving Mode is set to “On” option, during the measurement, if there is no key operation for 1 minute, the screen display will be dim for power saving. The display brightness will resume to normal condition by pressing any key.

Figura 4.10K Modalità Demo

4.3.8 Alerts

On main menu screen, move the cursor on “Alerts” and press Conrm key “ ”, then the oximeter enters into alerts setting screen, as shown in gure 4.11.

Figure 4.11 Alerts setting screen

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• SpO2 Lo-Limit:

SpO2 low limit setting; range: 50%~99%, the step is 1%. The fac-

tory default value for adult is 90% and 95% for Neonate.

• PR Hi-Limit: High limit setting of pulse rate; range: 100~240bpm. From 100 to 150,

the step is 1bpm, and from 150 to 240, the step is 5bpm. The factory default value for adult is 120bpm and 160bpm for neonate.

• PR Lo-Limit: Low limit setting of pulse rate; range: 30~99bpm, and the step is

1bpm. The factory default value for adult is 50bpm and 60bpm for neonate.

Note: When the

SpO2 reading is lower than or equal to the preset alert setting or the PR reading is higher than or equal to the preset high limit or the PR reading is lower than or equal to the preset low limit, then the over-limit alert event will be activated, that’s, the alert sound “bibibibi...” occurs, and the corresponding reading(s) blinks. When measured on neonate, if the

SpO2 reading is lower than or equal to the preset

alert setting for 10 seconds, then the alert sound and blinking display will be activated.

4.3.9 Help

On main menu screen, move the cursor on “Help” and press Conrm key “ ”, then the oximeter help information screen, which shows

SpO2 and temperature meas-

urement tips, as shown in gure 4.12.

Help

Baby L

Infant Pediatric

Note: Make sure the light

emitting and receiving ends

are aimed at each other. V

1/2

Help

Note: Remove temperature probe

cover, insert the probe into earhole,

then press key to start measurement.

2/2

Figure 4.12 Help information Figure 4.12 Help information

---SpO2 measurement ---TEMP measurement

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4.4 Record

4.4.1 Data Recall

On main default screen, short time press Record/Back key “ ” to enter into data recall screen, as shown in gure 4.13.

Figure 4.13 SpO2 record

SpO2 records include two types, Spot-check and Trend Record, Spot-check Record is a list showing the recording time, spot-checking event, as shown in gure 4.14

The corresponding

User ID for the

selected record

SpO2 value and pulse rate value for each

User and

Figure 4.14 Spot-check Record list

If Trend Record is selected, then the screen shows a list of trend data record, and each record corresponds to a period of recording at a xed time interval (1 second),

as shown in gure 4.15, press Up/Down key ( /  ) to select one record you need to review. Select one record you need to review, and press Conrm key “ ”, then the screen shows the corresponding User, User ID, and trend graph, as shown in gure

4.16.

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The corresponding

User and

User ID for the

selected record

Figure 4.15 Trend record---List

The corresponding

User and

User ID for the

selected record

SpO

trend graph

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Recording time

PR trend graph

Figure 4.16 Trend record---Trend graph

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4.4.2 Data Deletion

On the record list screen shown in gure 4.14 or 4.15, move the cursor on the record

you want to delete, and longtime pressing Sound/Right key (“ ”), then an message “Are you sure to delete all?” prompts on the screen, as shown in gure 4.16.

Figure 4.16 Delete records

At this time, short time press Menu/Conrm (“ ”) key to conrm and delete the records. Or short time press Record/Back (“ ”) key to return to record list screen.

4.4.3 Data Upload

If you want to upload the stored data (

SpO2, PR and TEMP values) to the computer, then Make sure the provided USB data cable is well connected between the device and PC before uploading data, as shown in gure 4.17. Refer to the instruction in “Oximeter Data Manager User Manual”for detailed operation.

Figure 417 Data uploading screen

• During data uploading, the user can not do any operation on the oximeter.

When the wireless transmission function is on, the Handheld Pulse Oximeter can communicate with a host (such as computer or mobile) for viewing and management. a. Open the host’s wireless function and procedure and start to scan the SP-20 Oxi-

meter. b. The host will pair with the SP-20 Oximeter at a moment. c. After connecting, the host can display and manage the measurement data of SP-20

by wireless

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The pairing and transmitting distance of wireless function is 8 meters in the normal. If the host can’t pair with the SP-20, you will try to narrow the distance between the host and SP-20. The SP-20 can pair and transmit with the host under the wireless coexistence environment, but other wireless device may still interface with pairing and transmission between the host and the SP-20 device under uncertain environment. If the host and the SP-20 display inconsistent, you may need to change the environment.

4.4.4 Data Management

The user can go to our website to download the corresponding PC Software “Oximeter Data Manager” for this oximeter with the link: http://www.creative-sz.com/ downloads With the computer installed this PC software, you can upload the data stored in the oximeter to your PC via wireless or data cable . It’s convenient for user to review the data records and statistical result, aa well as archive patients’ data.

5 Technical Specications

A. Display Panel: 3.5 inch color TFT LCD; B. Power Supply:

Internal power supply: 2000mAh lithium battery AC power adapter: 5VDC/1A, Working current: ≤180mA Input power for AC power adapter: <15VA The typical continuous operation time of the battery: 18 hours (when screen display

is automatically off and wireless function is disabled). The typical service life of the battery: 5 years.

C. SpO2 Measurement

Transducer: dual-wavelength LED sensor with wavelength: Red light: 663 nm, Infrared light: 890 nm. Maximal average optical output power: ≤ 2mW Display range: 0~100% Measuring accuracy: A

for

SpO2 range from 70% to 100%.

SpO2 low alert limit setting range: 50%~99% The device is calibrated to display functional oxygen saturation. The functional tester cannot be used to assess the accuracy of the

the device.

D. Pulse Rate Measurement

Display and measuring range: 30bpm~250bpm Accuracy: ±2bpm or ±2% (whichever is greater)

E. Perfusion Index Display

Range: 0.2%~20%

value (dened in ISO 80601-2-61) is not greater than 2%

RMS

SpO2 probe or

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F. Temperature Measurement

Measuring range: 32.0°C~43.0°C Measuring accuracy: ±0.2°C for temperature range from 35.0°C to 42.0°C, and

±0.3°C for the rest. Response time: ≤5s Patient Group: Adult and Neonate Measuring site: earhole Deviation: ≤0.1°C

G. Operating Environment

Operating Temperature: 5°C ~40°C Operating Humidity: 15%~93% Atmospheric pressure: 70kPa~106kPa Note: portable and mobile RF communications equipment may affect the perfor-

mance of the Oximeter.

H. Low Perfusion Performance

The accuracy of

SpO2 and PR measurement still meet the precision described

above when the modulation amplitude is as low as 0.4%.

I. Resistance to interference of surrounding light:

The difference between the

SpO2 value measured in the condition of indoor natural

light and that of darkroom is less than ±1%.

J. Wireless (bluetooth) function

Frequency band: 2.4GHz Working prole: BLE V4.0 K. Dimensions: 158 mm (L) × 73 mm (W) × 25 mm (H) Net Weight: about 230g (including battery)

L. Classication Type of protection against electric shock:

Internally powered equipment and Class II.

Degree of protection:

Type BF applied parts. Degree of protection against harmful ingress of liquids: The equipment is IP22

with protection against harmful solid foreign objects and ingress of liquid. Mode of operation: Continuous operation. Electro-Magnetic Compatibility: Group I, Class B

M. Data update period

The update time for determining

SpO2 and PR value is 8 seconds, and the display-

ing update time is 1 second. Remark: The oximeter calculates the

SpO2 and PR value, every second by use of recently acquired data segment, then yields the displaying value by moving average of the latest calculated parameters. The reading value of

SpO2 and PR on the oximeter is updated every second, and the displayed plethysmogram is a normalized waveform. If the signal is no integral (such as with too much noise, or poor signal to noise ratio or signal is lost), then the

SpO2 and PR will be identied as an invalid value, that’s to say, the numeric reading will disappear and be displayed as “--” instead.

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Note: The oximeter is calibrated in the factory before sale, and there is no need for

user to calibrate again.

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6 Over-limit Indication

6.1 Limit settings

•

SpO2 low limit setting range: 50% ~ 99%.

• Pulse Rate limits setting range: High: 100bpm--240bpm Low: 30bpm--99bpm

During the measurement, if the measured value exceeds the preset value, the alert beeping sound will be activated, the value that is over-limit will blink at the same time.

6.2

Over-limit indication sound mute setting

• During the measurement, if the global sound is enables, then short time press “ ” key to perform audible alert reset (that’s to say, the alert sound will be mute, and icon

“ ” appears on the upper right corner of the screen), but the over-limited value

still keeps blinking. when the current alert event ends or a new type of alert event occurs, then the status of audible alert reset will be ended (that’s to say, the alert sound can be generated when an alert event occurs, and icon “ ” appears on the upper right corner of the screen).

• When the global sound is enables, then the longtime pressing “ ” key cam

disable the global sound, and the sound icon becomes “ ”. Longtime pressing

“ ” key again can enable the global sound.

Note: “ ” means the speaker volume is set as 1 or 2 grid(s); “ ” means the

speaker volume is set as 3 or 4 grids; “ ” means the speaker volume is set as 5 or 6 grids.

• During the measurement, if the probe is off or disconnected, the message “Check Probe” shows and keeps blinking on the display screen. The alert sound starts (interval is 5 seconds). If the probe is still off and lasts for about 3 minutes, then the Oximeter will power off automatically.

7 Packing List

1. An Oximeter

2. A

SpO2 probe

3. User Manual

4. A oximeter rubber cover

5. A charging base

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6. A temperature probe (optional)

7. Charging cable (optional)

8. A USB data cable (optional)

Notes:

1. The accessories are subject to change. See the package in your hand for detailed items and quantity.

2. All the parts of the device should NOT be replaced at will. If necessary, please use the components provided by the manufacture or those that are of the same model and standards as the accessories along with the device which are provided by the same factory. Otherwise, negative effects concerning safety and biocompatibility etc. may be caused.

3. This device can only connect with the manufacture nominated device.

8 Repair and Maintenance

8.1 Maintenance

The expected service life(not a warranty) of this device is 5 years. In order to ensure its long service life, please pay attention to the maintenance;

•

If the battery is damaged, please contact your local sales representative or the manufacture.

•

Please store the device carefully to avoid being damaged by pets, pests or children.

•

The recommended storage environment of the device: Ambient temperature: -20ºC ~60ºC Relative humidity: 10%~95% Atmospheric pressure: 50kPa~107.4kPa Storage and Transportation between uses: – 25°C without relative humidity control; and + 70°C at a relative humidity up to 93% (non-condensing).

•

The oximeter is calibrated in the factory before sale, there is no need to calibrate it

during its life cycle. However, if it is necessary to verify its accuracy routinely, the user can do the verica-

tion by means of

SpO2 simulator, or it can be done by the local third party test house.

8.2 Cleaning and Disinfecting Instruction

• Surface-clean sensor with a soft cloth by wetting with a solution such as 75% iso-

propyl alcohol, if low-level disinfection is required, use a 1:10 bleach solution.

• Then surface-clean by a dampened cloth and let it air dry or wipe it with a cloth.

• Please clean and disinfect the device after using to avoid cross infection.

High-pressure disinfection cannot be used on the device. Do not immerse the device in liquid

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9 Troubleshooting

Trouble Possible Reason Solution

Unstable SpO2 and Pulse Rate display

Unable to measure Temperature

Device will not switch on

No Display 1. The device will power off

No Signal 1. Probe off or incorrect

1. The nger is not placed far enough inside.

2. The nger is shaking or the patient is moving.

1. Temperature probe is not connected properly

1. The batteries are drained or almost drained.

2. The device is malfunctioning.

automatically when there is no signal and no operation for 1 minute.

2. The battery voltage is low.

connection.

2. Incorrect nger insert

3. Probe is damaged.

1. Place the nger correctly inside and try again.

2. Reduce patient movement.

2. Reinsert the probe into the device

1. Recharge battery.

2. Please contact the local service center.

1. Normal.

2. Recharge battery.

1. Reconnect the probe.

2. Reinsert the nger.

3. Replace a new probe.

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10 Frequently Asked Questions

1. Q: What’s SpO2?

SpO2 means the saturation percentage of oxygen in the blood.

2. Q: What’s the normal range of SpO2 value for healthy people?

A: The normal range varies by individual, but usually over 95%, otherwise, please

consult your physician.

3. Q: What’s the normal range of PR value for healthy people? A: Usually, the normal range is 60bpm~100bpm.

5. Q: Why do the display value of SpO2 and PR vary with time? A: The measured

of patient’s physiological conditions.

5. Q: What to do if there is no SpO2 and PR reading? A: Do not shake the nger, and keep calm during the measurement. Please also

avoid the oximeter and the cuff on the same limb for blood pressure and oxygen saturation measurement simultaneously.

6. Q: How to conrm that the SpO2 reading is true or accurate? A: Hold breath for a while (50 seconds or more), if the

decreases, it means that the change.

7. Q: When to charge the batteries? A: The icon of low battery will appear on the screen when the battery voltages are

low. By then, device need to be charged.

8. Q: What factors will affect the SpO2 accuracy?

A: a) Intravascular dyes such as indocyanine green or methylene blue;

b) Exposure to excessive illumination, such as surgical lamps, bilirubin lamps, u-

orescent lights, infrared heating lamps, or direct sunlight;

c) Vascular dyes or external used color-up product such as nail enamel or color

skin care; d) Excessive patient movement; e) Placement of a sensor on an extremity with a blood pressure cuff, arterial cath-

eter, or intravascular line; f) Exposure to the chamber with High pressure oxygen; g) There is an arterial occlusion proximal to the sensor; h) Blood vessel contraction caused by peripheral vessel hyperkinesias or body

temperature decreasing; i) Low perfusion condition (Perfusion Index is small).

SpO2 and PR value changes in correspondence with the change

SpO2 value signicantly

SpO2 reading truly reects the physiological condition

Please contact the local distributor or manufacturer if necessary.

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Appendix

I. Key of Symbols

Symbols on the screen

Symbol Description

%SpO2 The oxygen saturation

PI% Perfusion Index

bpm

Pulse rate (Unit: beats per minute)

Pulse bar graph

Low battery voltage

Battery is full

Alert reset icon

Speaker mute icon

Speaker volume icon

SpO2 spot-check record memory full

SpO2 trend record memory full

ENGLISH

Temperature memory full

Wireless transmission icon

(Neonate/Adult) Patient type

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Symbols on the panels

Symbol Description Symbol Description

SpO2SpO2 probe connector

TEMP

Temperature probe connector

Power/Left Key Product code

Right/ Sound Key Lot number

Caution: read instructions (warnings) carefully

Keep in a cool, dry place

Auto-rotate/Up Key

Setting/Down Key Date of manufacture

Menu/Conrm key or Record/Back key

Serial number Type BF applied part

Medical Device complies with Directive 93/42/EEC

Authorized representative in the European community

WEEE disposal No alarm

Keep away from sunlight

Manufacturer

Follow instructions for use

Do not litter at will

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II. Common Knowledge

1 Meaning of SpO

SpO

is the saturation percentage of oxygen in the blood, so called O2 concentration

in the blood; it is dened by the percentage of oxyhemoglobin ( hemoglobin of the arterial blood. reect the respiration function; it is calculated by the following method:

SpO2 = HbO2 / (HbO2 +Hb)×100%

O2 are the oxyhemoglobins (oxygenized hemoglobin), Hb are those hemoglobins

which release oxygen.

2 Principle of Measurement

Based on Lamber-Beer law, the light absorbance of a given substance is directly proportional with its density or concentration. When the light with certain wavelength emits on human tissue, the measured intensity of light after absorption, reecting and attenuation in tissue can reect the structure character of the tissue by which the light passes. Due to that oxygenated hemoglobin (HbO2) and deoxygenated hemoglobin (Hb) have different absorption character in the spectrum range from red to infrared light (600nm~1000nm wavelength), by using these characteristics, termined. percentage of the hemoglobin that can transport oxygen. In contrast, hemoximeters report fractional oxygen saturation – a percentage of all measured hemoglobin, including dysfunctional hemoglobin, such as carboxyhemoglobin or metahemoglobin. Clinical application of pulse oximeters: to reect the respiration and ventilation function, so cal becomes more popularly, such as monitoring the patient with serious respiratory disease, the patient under anesthesia during operation, premature and neonate. The status of patient earlier, thereby preventing or reducing accidental death caused by hypoxia effectively.

3 Normal SpO2 Range and Default Low Limit

In campagna area, healthy people’s ues below 94% are determined as hypoxia.

threshold for determining anoxia by most researchers, so ter is set as 90% generally.

4 Factors affecting SpO2 accuracy (interference reason)

• Intravascular dyes such as indocyanine green or methylene blue.

• Exposure to excessive illumination, such as surgical lamps, bilirubin lamps, uorescent lights, infrared heating lamps, or direct sunlight.

• Vascular dyes or external used color-up product such as nail enamel or color skin care.

) in the total

SpO

is an important physiological parameter to

SpO2 can be de-

SpO2 measured by this oximeter is the functional oxygen saturation -- a

SpO2 is an important physiological parameter

SpO2 monitoring used in clini-

SpO2 can be determined in time by measurement and nd the hypoxemia

SpO

value is greater than 94%, so the val-

SpO2 <90% is considered as the default

SpO2 low limit of the oxime-

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• Excessive patient movement.

• Placement of a sensor on an extremity with a blood pressure cuff, arterial catheter, or intravascular line.

• Exposure to the chamber with High pressure oxygen.

• There is an arterial occlusion proximal to the sensor.

• Blood vessel contraction caused by peripheral vessel hyperkinesias or body temperature decreasing.

5 Factors causing low SpO2 value (pathology reason)

• Hypoxemia disease, functional lack of HbO2.

• Pigmentation or abnormal oxyhemoglobin level.

• Abnormal oxyhemoglobin variation.

• Methemoglobin disease.

• Sulfhemoglobinemia or arterial occlusion exists near sensor.

• Obvious venous pulsations.

• Peripheral arterial pulsation becomes weak.

• Peripheral blood supply is not enough.

Disposal: The product must not be disposed of along with other domestic waste. The users must dispose of this equipment by bringing it to a specic recycling point for electric and electronic equipment. For further information on recycling points contact the local authorities, the local recycling center or the shop where the product was purchased. If the equipment is not disposed of correctly, nes or penalties may be applied in accordance with the national legislation and regulations.

GIMA WARRANTY CONDITIONS

Congratulations for purchasing a GIMA product. This product meets high qualitative standards both as regards the material and the production. The warranty is valid for 12 months from the date of supply of GIMA. During the period of validity of the warranty, GIMA will repair and/or replace free of charge all the defected parts due to production reasons. Labor costs and personnel traveling expenses and packaging not included. All components subject to wear are not included in the warranty. The repair or replacement performed during the warranty period shall not extend the warranty. The warranty is void in the following cases: repairs performed by unauthorized personnel or with non-original spare parts, defects caused by negligence or incorrect use. GIMA cannot be held responsible for malfunctioning on electronic devices or software due to

outside agents such as: voltage changes, electro-magnetic elds, radio interferences, etc.

The warranty is void if the above regulations are not observed and if the serial code (if available) has been removed, cancelled or changed. The defected products must be returned only to the dealer the product was purchased from. Products sent to GIMA will be rejected.

Page 34

FRANÇAIS

Cher client, Merci pour avoir acheté ce produit de qualité. Veuillez lire attentivement le mode d’emploi avant d’utiliser l’appareil. Le non respect de ces instructions peut causer des anomalies dans les résultats de la mesure ou endommager l’oxymètre. Il est interdit de photocopier, reproduire ou traduire ce document sans l’accord écrit préalable du fabricant. Nous nous réservons le droit de mettre à jour ou de modier ce mode d’emploi à tout moment sans préavis.

Remarques :

• Les informations contenues dans ce mode d’emploi pourront être modiées sans préavis.

• Les informations fournies par Creative sont considérées comme étant précises et ables. Toutefois, Creative n’assume aucune responsabilité quant à leurs utilisations, aux problèmes de violation de brevets ou d’autres droits de tiers qui seraient la conséquence de leur utilisation.

Instructions pour une utilisation en toute sécurité

Contrôlez l’appareil pour vous assurer de l’absence de dommages visibles qui pourraient compromettre la sécurité de l’utilisateur et les résultats des mesures. Il est recommandé de contrôler l’appareil au moins avant chaque utilisation. En cas de dommage évident, cessez immédiatement d’utiliser l’appareil. Les opérations d’entretien et de réparation ne doivent être effectuées que par des techniciens qualifiés. Les utilisateurs ne sont pas autorisés à effectuer ces opérations par eux-mêmes. L’oxymètre ne doit être utilisé qu’avec les équipements et accessoires spécifiés dans le Mode d’emploi.

Mises en garde

 Risques d’explosion — NE PAS utiliser l’oxymètre dans un environnement conte-

nant des gaz inammables, tels que certains produits anesthésiants inammables.

 N’utiisez PAS l’oxymètre sur le patient pendant une procédure d’IRM ou de CT. Cet

appareil N’EST PAS compatible avec les procédures IRM.

Mises en garde



Une gêne ou une douleur peuvent apparaitre si le capteur de l’appareil est appliqué au même endroit pendant longtemps, en particulier chez les patients souffrant d’une mauvaise microcirculation. Veuillez ne pas appliquer l’oxymètre au même endroit plus de 2 heures de suite et de réduire le temps d’application en cas de conditions anormales. Contrôlez et repositionnez fréquemment le capteur de l’oxymètre.

 Une mauvaise application du capteur

SpO2, créant une pression excessive pen-

dant une période prolongée, peut causer des blessures.

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FRANÇAIS

 Le fait de serrer trop le doigt avec le capteur

SpO2 peut provoquer des pulsations veineuses et gêner la circulation du sang, risquant ainsi de créer un œdème interstitiel, des phénomènes d’hypoxie et d’obtenir des mesures inexactes.

 Des tests de biocompatibilité ont été effectués sur toutes les parties appliquées,

mais certains patients particulièrement allergiques pourraient quand-même faire un choc anaphylactique. N’utilisez pas cet appareil chez ces patients.

 Dans le cas de certains patients, l’évaluation de l’endroit où placer le capteur doit

être effectuée de façon particulièrement soigneuse. Le capteur ne peut pas être appliqué sur un œdème ou sur une partie sensible.

 Respecter la réglementation locale lors de l’élimination de l’appareil et de ses ac-

cessoires, une fois leur durée de vie utile terminée.

 NE faites PAS faire fonctionner l’appareil dans des environnements où sont pré-

sentes de fortes interférences électromagnétiques produites par exemple par des appareils de radiologie, des télévisions, des talkie-walkies, etc.

 FaItes attention au câble du capteur

SpO2 lorsque vous utilisez l’oxymètre, an

d’éviter qu’il ne serre le cou du patient.

Remarques

 Protéger l’oxymètre en le tenant éloigné de la poussière, des vibrations, des subs-

tances corrosives, des substances explosives, des températures élevées et de l’humidité.

 Si l’oxymètre devait être mouillé, cessez de l’utiliser jusqu’à ce qu’il soit sec.

Contrôlez qu’il fonctionne encore correctement avant de recommencer à l’utiliser. Lorsque l’appareil est déplacé d’un lieu froid à un lieu chaud et humide, ne l’utilisez pas immédiatement. Attendez au moins 15 minutes pour que la température de l’oxymètre atteigne la température ambiante.

 N’appuyez PAS sur les boutons placés sous l’écran avec des outils coupants ou

pointus.

 NE stérilisez PAS l’oxymètre et les capteurs avec de la vapeur à haute pression

ou avec des procédures de stérilisation à haute température. Faites référence au chapitre de ce Mode d’emploi relatif au nettoyage et à la désinfection.

 Cet appareil n’est pas prévu pour une utilisation thérapeutique.  L’équipement a un degré de protection IP22 contre l’intrusion de corps solides et

liquides. Cela signie qu’il est protégé contre l’intrusion de corps solides supérieurs à 12,5 mm et contre les chutes de gouttes d’eau jusqu’à 15° de la verticale.

 Faites attention aux effets des bres textiles, de la poussière, de la lumière (lumière

solaire comprise), etc.

Déclaration de conformité

Le fabricant déclare que cet appareil est conforme aux normes suivantes : CEI 60601-1:2005+A1 : 2012, CEI60601-1-2: 2014, CEI60601-1-11: 2010, ISO 806012-61:2011 et suit les dispositions de la directive du conseil MDD93/42/CEE.