Gima CMS50Q1 Manual
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Gima CMS50Q1 Manual

Oxy-0 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 com-
prendre ce manuel avant d'utiliser le produit.
CMS50Q1 (GIMA 35057)
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 -
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.
www.gimaitaly.com
+60°C
-40°C
0%
95%
1060hPa
500hPa
%
0123
IP22

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Summary of Contents for Gima 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 accordan- ce with the council directive MDD93/42/EEC for medical devices and harmonized standards. The Manual is written for the current Pulse Oxi- meter.

  • Page 3: Instructions For Safe Operations

    ENGLISH WARNING: 0 The uncomfortable or painful feeling may appear if using the device ceaselessly, especially for the microcirculation 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 in- specting in the placing process.
  • Page 4 ENGLISH 1.2 Warnings • Explosive hazard - DO NOT use the oximeter in environment with inflammable gas such as some ignitable 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. •...

  • Page 5: Indication For Use

    ENGLISH The product is suitable for children (Weight should be between 10 kg to 40kg). Prevent children from swallowing the product or its accessories.For children users, please use the product under the condition of adult guardianship The device may not work for all patients. If you are unable to achieve stable readings, discontinue use.

  • Page 6: Major Applications And Scope Of Application

    ENGLISH of children in home use environments.This device is not intended for continuous monitoring.The device can be multi-used.Pulse oximeter intended for wellness use. 2 Overview The pulse oxygen saturation is the percentage of HbO2 in the total Hb in the blood, so-called the O2 concentration in the blood. It is an important bio-parameter for the respiration.

  • Page 7: Environment Requirements

    ENGLISH nary sickroom), Oxygen Bar, social medical organizations and also the measure of saturation oxygen and pulse rate. 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 circumstance.

  • 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 attached illustration of this manual, Figure 5), or else it may cause inaccurate measu- rement.

  • Page 9: Technical Specifications

    ENGLISH pulsating blood flow of subject is required. For a subject with weak pulse due to shock, low ambient/body temperature, major bleeding, or use of vascular contracting drug, the SpO2 waveform (PLETH) will decrease. In this case, the measurement will be more sensitive to interference.

  • Page 10: Installation

    ENGLISH Resistance to surrounding light: The deviation between 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 7 Operating Guide 1) Insert the two batteries properly to the direction, and then replace the cover. 2) Open the clip as shown in Figure 5. 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.

  • Page 13: Troubleshooting

    ENGLISH • Please change the batteries when the low-voltage displayed on the screen. • Please clean the surface of the device before using. Wipe the device with medical alcohol first, and then let it dry in air or clean it by dry clean fabric.

  • Page 14: Key Of Symbols

    ENGLISH 1. The batteries are drained or almost drained. 1. Change batteries. The device can 2. The batteries are not 2. Reinstall batteries. not be turned on inserted properly. 3. Please contact the local 3. The malfunction of the service center. device.
  • Page 15 ENGLISH Serial number Alarm inhibit WEEE disposal IP22 Covering Protection rate Medical Device complies with Directive 93/42/EEC Manufacturer Date of manufacture Temperature limit Humidity limit Atmospheric pressure limit This side up Fragile; maneggiare con cura...

  • Page 16: Function Specification

    ENGLISH 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) Pulse Rate (PR) Pulse Intensity (bar-graph) LCD bar-graph display Pulse wave SpO2 Parameter Specification...
  • Page 17 Guidance and manufacture’s declaration –electromagnetic emission The CMS50Q1 Pulse Oximeter is tended for use in the electromagnetic environment specified below. The customer of the user of the CMS50Q1 Pulse Oximeter should assure that it isused in such an environment. Emission test...
  • Page 18 EQUIPMENT and SYSTEMS that are not LIFE-SUPPORTING Guidance and manufacture’s declaration-electromagnetic immunity The CMS50Q1 Pulse Oximeter is intended for use in the electromagnetic environment specified below. The customer or the user of CMS50Q1 Pulse Oximeter should assure that it is used in such an environment. 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 800MHz to 2.5GHz...
  • Page 20 RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which The CMS50Q1 Pulse Oximeter is used exceeds the applicable RF compliance level above, the CMS50Q1 Pulse Oximeter should be observed to verify normal operation.
  • 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...

This manual is also suitable for:

35057

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