Gima OXY-0 CMS50Q1 Instructions To User
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Gima OXY-0 CMS50Q1 Instructions To User

Pediatric oximeter
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PROFESSIONAL MEDICAL PRODUC TS
PULSOXIMETRO PEDIATRICO OXY-0
OXY-0 PEDIATRIC OXIMETER
OXYMÈTRE PÉDIATRIQUE OXY-0
OXÍMETRO PEDIÁTRICO OXY-0
OXY-0 PEDIATRIC OXYMETER
OXY-0 PULSOXIMETRU PEDIATRIC
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.
ATENÇÃO: Os operadores devem ler e entender completamente este manual antes de usar o
produto.
FÖRSIKTIGHET: Operatörer måste läsa och helt förstå denna manual innan produkten används.
ATENȚIE: Operatorii trebuie să citească și să înțeleagă pe deplin acest manual înainte de a
utiliza produsul.
CMS50Q1 (GIMA 35056)
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
Importato da / Imported by / Importé par / Importado por /
Importat de / Importerad av:
Gima S.p.A. Via Marconi, 1 - 20060 Gessate (MI) Italy
gima@gimaitaly.com - export@gimaitaly.com
www.gimaitaly.com
+60°C
%
-40°C
0%
95%
1060hPa
500hPa
0123
IP22

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Summary of Contents for Gima OXY-0 CMS50Q1

  • Page 1 Shanghai International Holding Corp. GmbH (Europe) Eiffestrasse 80, 20537, Hamburg, Germany Importato da / Imported by / Importé par / Importado por / Importat de / Importerad av: Gima S.p.A. Via Marconi, 1 - 20060 Gessate (MI) Italy gima@gimaitaly.com - export@gimaitaly.com www.gimaitaly.com 1060hPa +60°C...

  • Page 2: Pulse Oximeter

    ENGLISH Pulse Oximeter CMS50Q1 Instructions to User Dear Users, thank you very much for purchasing our product. This Manual is written and compiled in accordance with the council directive MDD93/42/EEC for medical devices and harmonized standards. The Manual is written for the current Pulse Oximeter. In case of modifi- cations and software upgrades, the information contained in this document is subject to change without notice.

  • Page 3: Instructions For Safe Operations

    ENGLISH 0 The uncomfortable or painful feeling may appear if using the device ceaselessly, especially for the micro- circulation barrier patients. It is recommended that the sensor should not be applied to the same finger for over 2 hours. 0 For the individual patients, there should be a more prudent inspecting in the placing process.
  • Page 4 ENGLISH anesthetic agents. • DO NOT use the oximeter while the testee measured by MRI and CT. • The person who is allergic to rubber can not use this device. • The disposal of scrap instrument and its accessories and packings(including battery, plastic bags, foams and paper boxes) should follow the local laws and regula- tions.

  • Page 5: Indication For Use

    ENGLISH  Do not use the device on infant or neonatal patients.  The product is suitable for children (Weight should be between 10 kg to 40kg).  Prevent children from swallowing the product or its ac- cessories.For children users, please use the product under the condition of adult guardianship  The device may not work for all patients.

  • Page 6: Major Applications And Scope Of Application

    ENGLISH The Pulse Oximeter is a non-invasive device intended for the spot-check of saturation of arterial hemoglobin(- SpO2) and the pulse rate of children in home use en- vironments.This device is not intended for continuous monitoring.The device can be multi-used.Pulse oximeter intended for wellness use.

  • Page 7: Environment Requirements

    ENGLISH indicate the pulse intensity by the bar-display. The product is suitable for use in family, hospital (Ordinary sickroom), Oxygen Bar, social medical organizations and also the measure of saturation oxygen and pulse rate. The product is not suitable for use in continuo- us supervision for patients..

  • Page 8: Clinical Restrictions

    ENGLISH Glow and Infrared-ray Emission Tube Glow and Infrared-ray Receipt Tube Figure 1 Operating principle 3.2 Precautions 1. The finger should be placed properly (see the atta- ched illustration of this manual, Figure 5), or else it may cause inaccurate measurement. 2.

  • Page 9: Technical Specifications

    ENGLISH (PLETH) will decrease. In this case, the measurement will be more sensitive to interference. 2. For those with a substantial amount of staining dilu- tion drug (such as methylene blue, indigo green and acid indigo blue), or carbon monoxide hemoglobin (COHb), or methionine (Me+Hb) or thiosalicylic he- moglobin, and some with icterus problem, the SpO2 determination by this monitor may be inaccurate.

  • Page 10: Installation

    ENGLISH en the value measured in the condition of man-made light or indoor natural light and that of darkroom is less than ±1%. 8. It is equipped with a function switch: The product will enter standby mode when no signal is in the product within 5 seconds.

  • Page 11: Mounting The Hanging Rope

    ENGLISH Figure 3 Batteries installation Figure 4 Mounting the hanging rope 6.2 Battery Step 1. Refer to Figure 3. and insert the two AAA size batteries properly in the right direction. Step 2. Replace the cover, turn the screw. Please take care when you insert the batteries for the improper insertion may damage the device.

  • Page 12: Repairing And Maintenance

    ENGLISH Figure 5 Put finger in position 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. 4) Press the button once on front panel. 5) Do not shake the finger and keep the patient at ease during the process.

  • Page 13: Troubleshooting

    ENGLISH 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 device, or even damage it. 9 Troubleshooting Problem Possible cause Solution 1.

  • Page 14: Key Of Symbols

    ENGLISH 10 Key of Symbols Type BF applied part Follow instructions for use The pulse oxygen saturation (%) Pulse rate (bpm) PR bpm The battery voltage indication is deficient (change the battery in time avoiding the inexact measure) 1. No finger inserted 2.

  • Page 15: Function Specification

    ENGLISH Humidity limit Atmospheric pressure limit This side up Fragile; maneggiare con cura Keep away from sunlight Keep away from sunlight Product code Lot number Caution: read instructions (warnings) carefully Authorized representative in the European community 11 Function Specification Display Information Display Mode The Pulse Oxygen Saturation (SpO2)
  • Page 16 ENGLISH Measuring range 0% ~ 100%, (the resolution is 1%). 70% ~ 100%: ±2%, Below 70% Accuracy unspecified. Red light (wavelength is 660 nm) Optical Sensor Infrared (wavelength is 880 nm) Pulse Parameter Specification 30 bpm ~ 250 bpm (the resolution Measuring range is 1 bpm) Accuracy...
  • Page 17 ENGLISH Electromagnetic Emission test Compliance environment-guidance The CMS50Q1 Pulse Oximeter uses RF energy only for their internal RF emissions function. Therefore, its RF Group 1 CISPR 11 emissions are very low and are not likely to cause any interference in nearby electronic equipment.
  • Page 18 ENGLISH Power frequency Power magnetic fields frequency should be at levels (50Hz) characteristic of a 3 A/m 3 A/m magnetic field typical location in a typical commercial 61000-4-8 or hospital environment. Guidance and manufacture’s declaration-electromagnetic immunity for EQUIPMENT and SYSTEMS that are not LIFE-SUPPORTING Guidance and manufacture’s declaration-electromagnetic immunity...
  • Page 19 ENGLISH Portable and mobile RF communication equipment should be used no closer to any part of the CMS50Q1 Pulse Oximeter, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. recommended separation distance 80MHz to 800MHz...
  • Page 20 ENGLISH NOTE 1 At 80MHz and 800MHz, the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. a. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcastcannot be predicted theoretically with accuracy.
  • Page 21 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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