AlcoSense YK-81A Посібник користувача - Сторінка 2

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Safety and precautions for use

1. Do not use the Fingertip Pulse Oximeter near operational MRI or CT equipment.

2. Explosion hazard: Do not use the Fingertip Pulse Oximeter in an explosive atmosphere.

3. The Fingertip Pulse Oximeter is intended only as a supplementary tool in patient assessment. Patients should be

diagnosed in conjunction with clinical manifestations and symptoms.

4. Check the skin around the Fingertip Pulse Oximeter regularly to ensure that the circulation and skin are unaﬀected.

5. Do not drag the rubber surface against the skin while putting on or removing the Fingertip Pulse Oximeter sensor.. This may

cause inaccurate readings, injury or irritation.

6. Please read this manual carefully before operation and retain for future reference.

7. The Fingertip Pulse Oximeter is not designed for continuous monitoring.

8. Repeated use or the patient's condition may require changing the finger used periodically. Check skin condition, circulatory

status, and correct alignment at least every 2 hours.

9. Do not autoclave, use ethylene oxide for sterilizing or immersing the Oximeter in liquid.

10. Significant levels of dysfunctional haemoglobins (such as carboxyl-haemoglobin or methaemoglobin) may cause

inaccurate readings.

11. Intravascular dyes such as indocyanine green or methylene blue may cause inaccurate readings.

12. SpO2 measurements may be adversely aﬀected in the presence of high ambient light. Please shield the Oximeter from

direct sunlight or spot lights if necessary.

13. Finger movements or patient movement may cause inaccurate readings.

14. Electromagnetic interference, high frequency radio waves or interference caused by defibrillators may lead to inaccurate

readings.

15. Venous pulsations may cause inaccurate readings.

16. Inaccurate readings may be caused if the Oximeter is in the same limb where reduced blood flow are expected, for

example from a blood pressure cuﬀ, arterial catheter or intravascular line.

17. Hypotension, severe vasoconstriction, severe anaemia, or hypothermia may cause inaccurate readings.

18. Inaccurate readings may be displayed in patients administered with Cardiotonic drugs after cardiac arrest or if the patient

is experiencing heart quiver or flutter.

19. Painted nails may cause inaccurate SpO2 readings.

Scope of application / Intended use

The fingertip pulse Oximeter can be used to measure human haemoglobin saturation and pulse rate through the finger. It can

be used in hospitals, at home, in schools and medical centres.

Contraindication: Not found

Please Note:

1. Images in this user manual may diﬀer slightly from the actual instruments.

2. Technical parameters and appearance may change without prior warning.

Maintenance, storage and disposal

1. Replace batteries when the low battery indicator is active.

2. Clean the surface of fingertip pulse Oximeter with medical alcohol before it is used to diagnose patients.

3. If the Oximeter will be stored for extended periods of time, remove the batteries from the device.

4. Store in accordance with the temperature, humidity and air pressure specified in the Technical Parameters.

5. Keep the product dry at all times. Moisture may aﬀect its expected operational lifetime and damage the product.

Please follow local guidance on the recycling of the product, packaging, accessories and batteries. The

Oximeter and batteries require disposal as Electrical Waste and must not be disposed of in normal

recycling or waste.

Classification

1. Management Class for Medical Devices: Ⅱequipment

2. Anti-electric Shock Type: Internally powered equipment

3. Anti-electric Shock Degree: Type BF equipment

Guidance and manufacturer's declaration on electromagnetic radiation for other EQUIPMENT and SYSTEMS

The Fingertip Pulse Oximeter is designed to be used in specified electromagnetic environments.

Users of the Fingertip Pulse Oximeter must use it in the following environments.

Radiation Test

Compliance

Electromagnetic environment-guidance

RF signal of Fingertip Pulse Oximeter is simply created by its internal

RF interference

Group 1

function. Therefore, its RF interference is very low and is not likely to

CISPR 11

cause any interference to nearby electronic equipment.

The Fingertip Pulse Oximeter applies to all establishments,

including domestic establishments and those directly connected

RF interference

Class B

to the public low-voltage power supply network that supplies

CISPR 11

buildings used for domestic purposes.

Symbols and Definitions

BF type

IP22

IP rating

application part

Electrical waste

Humidity range

disposal required

Consult manual

Keep dry

Caution

Product certification

European Union Representative

Product Accessories

1. One lanyard chord

2. One user manual

Serial number

Lot number

Date of manufacture

Temperature range

Manufacturer

Avoid sunlight

Standby

Store this way up

Trouble shooting

Problem

Possible reason

1. Finger is not inserted correctly

SpO2 or Pulse Rate

2. Patient is wearing nail polish

cannot be shown

3. Patient's Oxyhemoglobin value is

normally

too low to be measured

1. Finger is not inserted correctly

SpO2 or Pulse Rate is

2. Patient is wearing nail polish

inconsistent

3. The finger or patient may be

moving

1. Battery power may be exhausted

The Oximeter can not be

2. Batteries might be installed

turned on

incorrectly

3. The Oximeter may be damaged

1. The product automatically shuts

The Oximeter suddenly

oﬀ when no signal is detected for 8

turns oﬀ

seconds

2. Battery power may be exhausted

Statement

1. Repairs may only be undertaken by the factory or the company detailed in section 15 of this manual. Circuit diagrams etc

are not available.

2. Records of the certification and compliance documents for the product can be requested from the local service centre.

3. The operation, specification or design of the product may be changed without prior notice.

4. The instrument cannot be used for accuracy testing of other blood oxygen probe pulse & pulse blood oxygen monitors.

After-sales service

Ensure that users

Please read user manual before using the instrument.

Follow the requirements listed in this user manual with regard to operation, storage, maintenance and environmental

requirements.

How to contact us

Telephone lines are open Monday to Friday 0900 to 1700 GMT, excluding back holidays.

Please email [email protected] or call 01628 778885 from the UK, or from Ireland call 01 513 7065. From outside the

UK or Ireland call +44 1628 778885.

Conditions of warranty

As standard your Oximeter comes with a one-year limited warranty from the time of purchase. To qualify for warranty

repair or replacement you must provide a valid proof of purchase from an authorised retailer with any warranty claim.

Warranty does not include the following:

• Fault caused by human factors including but not limited to accidental damage beyond reasonable wear and tear;

• Use of the product outside the specified environmental requirements.

• Due to disassembly or repair attempts made by those other than the authorised service centre.

• Products beyond the warranty period of one year from purchase.

• Products bought second hand.

• Products not bought from an authorised retailer.

If you have any problem, please email [email protected] or call 01628 778885 from the UK, or from Ireland

call 01 513 7065 (International (+44 1628 778885).

Company and contact information

Exclusive UK and IE Distributor:

AlcoSense Laboratories

Part of Now Group UK Ltd

Unit 3, Maidenhead Enterprise Centre,

Cordwallis Street,

Maidenhead, Berkshire

SL6 7BE. United Kingdom

Xuzhou Yongkang Electronic Science Technology Co., Ltd

4F Building C8, 40 Jingshan Road, Economic and Technological Development Zone,

Xuzhou, China

The authorised representative of European Union:

Prolinx GmbH, Brehmstr . 56 , 40239 , Duesseldorf

Germany

Solution

1. Try reinserting the finger or swapping fingers.

2. Make sure the finger is inserted the right way up.

3. Remove nail polish, if present, and try again.

4. Try more times. Verify the product is working

correctly on another person. If you are still

experiencing problems, seek medical assistance.

1. Try reinserting the finger or swapping fingers.

2. Sit down and keep the hands and body still.

3. Remove nail polish, if present, and try again.

1. Install new AAA Alkaline batteries.

2. Reinstall the batteries, making sure they are

inserted the correct way round.

3. Contact us. Details can be found in section 15.

1. Try inserting a finger in the Oximeter again.

2. If it still won't power up, install new AAA Alkaline

batteries and insert finger again.

3. Contact us. Details can be found in section 15.

email: [email protected]

UK Tel: 01628 778885

IE Tel: 01 513 7065

International: +44 1628 778885

Opening hours: Mon-Fri 0900-1700,

exc. bank holidays

Web: www.alcosense.co.uk/oxipro