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PROFESSIONAL MEDICAL PRODUCTS
OXY-1 FINGER OXIMETER
OXÍMETRO DE PULSO OXY-1
ΠΑΛΜΙΚΌ ΌΞΎΜΕΤΡΌ OXY-1
OXY-1 FINGEROXIMETER
OXY-1 VINGEROXIMETER
PULSOXIMETRU PENTRU DEGET OXY-1
35070 / CMS50DL
CONTEC MEDICAL SYSTEMS CO., LTD
No.112 Qinhuang West Street,
Economic & Technical Development Zone,
Qinhuangdao, Hebei Province,
PEOPLE'S REPUBLIC OF CHINA
Made in China
Shanghai International
Holding Corp. GmbH (Europe)
Eiffestrasse 80, 20537,
Hamburg, Germany
Imported by / Importado por / Εισαγωγή από /
Importeret af / Geïmporteerd door / Importat de:
Gima S.p.A.
Via Marconi, 1 - 20060 Gessate (MI) Italy
gima@gimaitaly.com - export@gimaitaly.com
www.gimaitaly.com
IP22
60°C
-40°C
500 hPa
0123
1060 hPa
95%
0%
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Summary of Contents for Gima OXY-1
- Page 1 PROFESSIONAL MEDICAL PRODUCTS OXY-1 FINGER OXIMETER OXÍMETRO DE PULSO OXY-1 ΠΑΛΜΙΚΌ ΌΞΎΜΕΤΡΌ OXY-1 OXY-1 FINGEROXIMETER OXY-1 VINGEROXIMETER PULSOXIMETRU PENTRU DEGET OXY-1 35070 / CMS50DL 0123 CONTEC MEDICAL SYSTEMS CO., LTD No.112 Qinhuang West Street, Economic & Technical Development Zone, Qinhuangdao, Hebei Province, PEOPLE’S REPUBLIC OF CHINA...
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Page 2: Instructions To User
ENGLISH Instructions to User Dear users, thank you very much for purchasing the Pulse Oximeter. This Manual is written and compiled in accordance with the council directive MDD93/42/EEC for medical devices and harmonized standards. In case of modifications and soft- ware upgrades, the information contained in this document is subject to change without notice. -
Page 3: Instructions For Safe Operations
ENGLISH inspecting in the placing process. The device can not be clipped on the edema and tender tissue. The light (the infrared is invisible) emitted from the device is harmful to the eyes, so the user and the maintenance man should not stare at the light. - Page 4 ENGLISH • The person who is allergic to rubber can not use this de- vice. • The disposal of scrap instrument and its accessories and packings(including battery, plastic bags, foams and paper boxes) should follow the local laws and regulations. •...
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Page 5: Indication For Use
ENGLISH and adults(Weight should be between 15kg to 110kg). The device may not work for all patients. If you are una- ble to achieve stable readings, discontinue use. The update period of data is less than 5 seconds, which is changeable according to different individual pulse rate. -
Page 6: Major Applications And Scope Of Application
ENGLISH 2 OVERVIEW The pulse oxygen saturation is the percentage of HbO the total Hb in the blood, so-called the O concentration in the blood. It is an important bio-parameter for the respira- tion. For the purpose of measuring the SpO more easily and accurately, our company developed the Pulse Oximeter. -
Page 7: Environment Requirements
ENGLISH The product is not suitable for use in continuous supervision for patients. The problem of overrating would emerge when the patient is suffering from toxicosis which caused by carbon monoxide, the device is not recommended to be used under this circum- stance. -
Page 8: Clinical Restrictions
ENGLISH Glow and Infrared-ray Emission Tube Glow and Infrared-ray Receipt Tube Figure 1. Operating Principle 3.2 Caution 1. The finger should be placed properly (see the attached illustration of this manual, Figure 5), or else it may cause inaccurate measurement. 2. -
Page 9: Technical Specifications
ENGLISH 2. For those with a substantial amount of staining dilution drug (such as methylene blue, indigo green and acid indigo blue), or carbon monoxide hemoglobin (COHb), or methionine (Me+Hb) or thiosalicylic hemoglobin, and some with icterus problem, the SpO determination by this monitor may be inaccurate. -
Page 10: Installation
ENGLISH 9. Optical Sensor Red light (wavelength is 660nm, 6.65mW) Infrared (wavelength is 880nm, 6.75mW) 5 ACCESSORIES • One hanging rope • Two batteries (optional) • One User Manual 6 INSTALLATION 6.1 View of the Front Panel Power switch Pulse rate Pulse rate The display SpO bargraph display... -
Page 11: Mounting The Hanging Rope
ENGLISH 6.2 Battery Step 1. Refer to Figure 3. and insert the two AAA size batter- ies properly in the right direction. Step 2. Replace the cover. Please take care when you insert the batteries for the improper insertion may damage the de- vice. -
Page 12: Repairing And Maintenance
ENGLISH 7 OPERATING GUIDE 7.1 Insert the two batteries properly to the direction, and then replace the cover. 7.2 Open the clip as shown in Figure 5. 7.3 Let the patient’s finger put into the rubber cushions of the clip (make sure the finger is in the right position), and then clip the finger. -
Page 13: Troubleshooting
ENGLISH High-pressure sterilization cannot be used on the device. Do not immerse the device in liquid. It is recommended that the device should be kept in a dry environment. Humidity may reduce the useful life of the de- vice, or even damage it. 9 TROUBLESHOOTING Trouble Possible Reason... - Page 14 ENGLISH 10 SYMBOLS Symbol Description Type BF applied part % SpO The pulse oxygen saturation(%) PRbpm Pulse rate (bpm) The battery voltage indication is deficient (change the battery in time avoiding the inexact measure) 1. No finger inserted 2. An indicator of signal inadequacy Battery positive electrode Battery cathode Power switch...
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Page 15: Function Specification
ENGLISH Manufacturer Authorized representative in the European community Date of manufacture Store between -40 and 60°C Humidity limitation Atmospheric pressure limitation 11 FUNCTION SPECIFICATION Display Information Display Mode The Pulse Oxygen Digital Saturation (SpO Pulse Rate (BPM) Digital Pulse Intensity (bar-graph) Digital bar-graph display Parameter Specification Measuring range... - Page 16 ENGLISH Battery Useful Life Two batteries can work continually for 24 hours Dimensions and Weight Dimensions 57(L) × 31(W) × 32(H) mm Weight About 50g (with the batteries) Appendix:Electromagnetism Compatibility Guidance and manufacture’s declaration – electromagnetic emissions- for all EQUIPMENT and SYSTEMS Guidance and manufacture’s declaration –...
- Page 17 ENGLISH Guidance and manufacture’s declaration – electromagnetic immunity – for all EQUIPMENT and SYSTEMS Guidance and manufacture’s declaration – electromagnetic im- munity The CMS50DL is intended for use in the electromagnetic environment specified below. The customer or the user of CMS50DL should assure that it is used in such an environment.
- Page 18 ENGLISH Power 3 A/m 3 A/m Power frequency mag- netic fields sould be at frequency levels characteristic of (50/60Hz) a typical location in a Magnetic field typical commercial or IEC-61000-4-8 hospital environment. NOTE U is the a.c. mains voltage prior to application of the test level.
- Page 19 ENGLISH Where P is the maximum output power rating of the transmitter in watts (W) ac- cording 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,a should be less than the compliance level in each frequency range.b...
- Page 20 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 specific recycling point for electric and electronic equipment. GIMA WARRANTY TERMS The Gima 12-month standard B2B warranty applies.
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