Gima PC-900B User Manual
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Gima PC-900B User Manual

Gima PC-900B User Manual

Capnograph and oximeter
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PROFESSIONAL MEDICAL PRODUCTS
PC-900B CAPNOGRAPH AND
OXIMETER
User Manual
PC900B (Gima 33698)
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
Gima S.p.A.
Via Marconi, 1 - 20060 Gessate (MI) Italy
gima@gimaitaly.com - export@gimaitaly.com
www.gimaitaly.com
Gima S.p.A.
Via Marconi, 1 - 20060 Gessate (MI) Italy
gima@gimaitaly.com - export@gimaitaly.com
www.gimaitaly.com

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  • Page 1 Gima S.p.A. Via Marconi, 1 - 20060 Gessate (MI) Italy gima@gimaitaly.com - export@gimaitaly.com www.gimaitaly.com PROFESSIONAL MEDICAL PRODUCTS PC-900B CAPNOGRAPH AND OXIMETER User Manual PC900B (Gima 33698) Shenzhen Creative Industry Co., Ltd. Floor 5, BLD 9, BaiWangxin High-Tech Industrial Park, Songbai Road, Xili Street, Nanshan District, 518110 Shenzhen, P.R.
  • Page 2 Notice Thanks for buying PC -900B Capnograph and Oximeter. This manual is copyright reserved. It is prohibited to copy, duplicate or translate into other languages without our written permission. Please read this manual carefully and then follow its instructions when operating this monitor.

  • Page 3: Table Of Contents

    CONTENTS 1 Preface ......................4 1.1 Brief ....................... 4 1.2 Warranty and Maintenance ................ 4 1.3 Safety Requirements ................... 5 2 Technical specifications and characteristics ........... 8 3 Introduction of Monitor ................15 4 Patient connection ..................17 and Respiration rate measurement ........... 17 4.1 CO 4.2 CO2 Measure principle ................

  • Page 4: Preface

    1 Preface 1.1 Brief The purpose of this manual is to provide the user with a brief understanding of the characteristics, functions and operation of the monitor thereby preventing incorrect operation and user error. This monitor can measure four physical parameters at the same time: concentration of EtCO /FiCO , respiration rate, heart pulse rate and saturation of...

  • Page 5: Safety Requirements

    1.3 Safety Requirements For the purposes of safety, please read the following and abide by these instructions for medical instrumental products. Contraindications Do not use the device in an MR environment. Do not use the device during defibrillation. Do not use the device in an explosive atmosphere or in the presence of flammable anaesthetics or gases.
  • Page 6 blood pressure cuff or intravascular infusion line. • Do not use a damaged Sensor. • The monitor should only be operated by trained licenced practitioners. • The machinery life of Capnograph and Oximeter is 8 years. The Capnograph and Oximeter shall be collected and recycled in accordance with local law after 8 years.

  • Page 7: Symbols On The Monitor

    used must comply with regulations specified by the country in which the equipment is to be used. • Do not modify the monitor without authorization of the manufacturer. 1.4 Symbols on the Monitor Symbols Meaning Symbols Meaning Date of manufacture Manufacturer Serial number Caution...

  • Page 8: Technical Specifications And Characteristics

    2 Technical specifications and characteristics Intended Use The Capnograph and Oximeter is designed for monitoring the vital physiological signs of the patient. It is used for non-invasive continuous monitoring of oxygen saturation (SpO2), pulse rate, CO2 and respiration rate. The Capnograph and Oximeter is intended for use in adults, pediatrics and infants in a hospital environment.
  • Page 9 Transducer: Dual-wavelength LED Range: 0 - 100% Accuracy: ±2% for SpO range from 70 - 100%, 70% of the following does not require Memory: 24 hours on Screen Trend and Numeric Patient Modes: Adult and Pediatric Data Update Time: The functional tester cannot be used to assess the accuracy of the SpO2 probe or the device.
  • Page 10 Atmospheric pressure: 50 - 120 kPa Dimensions of Monitor Size: 70 x 160 x 40mm (W x H x D) Weight: Monitor 380g, Weight on Airway ETT/LMA <25g. Warranty & Maintenance/ Calibration One year warranty on main unit and lithium ion rechargeable battery Auto self-zeroing calibration, annual calibration check recommended IP rating IP32 when used in specified carry case...
  • Page 11 ambient temperature and humidity at that time. If the heat and humidity exchanger is added to the pipeline to filter part of moisture, the relative difference between the CO concentration measured by the device and the dry CO concentration is less than 1%. If converted to CO concentration in human alveoli (temperature 37°C, tidal pressure 47mmHg, BTPS), a compensation calculation is required.
  • Page 12 Table2: Interfering gas and vapour effects Interference to EtCO Interfering Gas or vapour +5% of reading 60% N Need to send N O concentration to the device to correct the data by compensation 4% Halothane Negligible interference Negligible interference 5% Enflurane Negligible interference 5% Isoflurane Negligible interference...
  • Page 13 Note5: Arms is defined as root-mean-square value of deviation according to ISO 80601-2-61. The table 3 with measured SpO accuracy specification in the discrete SpO ranges: Table 3 SpO2 range Arms 70%~80% 1.37 80%~90% 1.33 90%~100% 1.48 70%~100% 1.38 The graphical plot of all sampled data points, as shows in Figure 2.1: The above data (table 3 and Figure 2.1) is obtained from clinical validation study of the PC-900A (K093016) through a controlled, induced hypoxia study conducted with healthy adult volunteers.
  • Page 14 Figure 2.1 Note6: Reference method for pulse rate accuracy: Connect the monitor and the pulse oximeter simulator, set the SpO value of the simulator to 96%, and then set the pulse rate of the simulator to 30bpm, 60bpm, 120bpm, 200bpm, and 250bpm respectively. Observe the pulse rate value displayed by the monitor.

  • Page 15: Introduction Of Monitor

    3 Introduction of Monitor Figure 3.1 (1) Screen: Displays waves, menu, alarm and all measuring parameters. /▲: Function button: ▲ a) When menu (except the TREND menu) is activated, press this button to move the cursor. b) When the TREND menu is activated, this button changes between the trend graph and data table On the main display, to press this button to silence alarms for 2 minutes (3) ▼: Press this button to move the cursor when menu is activated.
  • Page 16 (6) ENTER: Confirmation button; a) Press this button to “Confirm” on the menu. b) In the main menu, press this button restart the pump if it has automatically switched OFF. Press this button to enter or quit menu or change display. Power button: hold for >2 seconds to activate.

  • Page 17: Patient Connection

    4 Patient connection 4.1 CO and Respiration rate measurement Push in and twist 45° clockwise to connect the Filter to the Connector on the top of the Monitor. Attach the selected Gas Sampling Line to the CO filter Female Luer Connector (Use a Male to Male Luer adapter if necessary) and then select a sampling point as close as possible to either the patient or the Ventilator Breathing Circuit.
  • Page 18 Figure 4.2 Instruction for use of the Filter 1.) Insert the convex cleat of Filter into the notch of the inlet port of device and turn 45°clockwise. 2.) Attach male luer lock sample line connector to Filter (Use a Male to Male Luer adapter if the sample line has Female Luer connector) 3.) Connect the other end of the Sample line to the chosen sampling point of patient or Ventilator Circuit.

  • Page 19: Co2 Measure Principle

    4.2 CO Measure principle 1). Theory introduction The device working theory is NON-DISPERSIVE INFRA GAS ANALYZER. The principle is based on the fact that CO molecules absorb infrared light energy of specific wavelengths, with the amount of energy absorbed being directly related to the CO concentration.

  • Page 20: Oximeter Density Measurement (Optional)

    show "OCCLUSION ', the operator needs to change the filter. 4.3 Oximeter density measurement (optional) 1). Theory introduction SpO2 is measured by Pulsating oximetry. This is a continuous, non-invasive method to measuring hemoglobin oxygenation saturation. It is determined the number of sensor light emitted from the light source side penetrating the patient tissue (such as a finger or ear), to the receiver sensor.

  • Page 21: Notice

    PLEASE NOTE: when SpO is not being monitored the probe should be disconnected from the monitor to save battery life, or the two windows of sensor should be kept face to face, otherwise the light window will remain operational and the photoplethysmogram wave will be disordered and the screen will display “FAIL SEARCH”.
  • Page 22 The approved sampling lines provided by or specified by the manufacturer or distributor, shall be used, otherwise readings may be inaccurate. Fast changes in ambient Temperature may cause inaccuracy and in this instance the Display will show “TEMP IMBALANCE”. The measured data may be influenced by different kinds of anaesthetic gases. If it is required to calibrate interference gases please refer to Appendix 2.

  • Page 23: Screen Display And Operation

    5 Screen display and Operation 5.1. Screen main display menu Figure 5.1 The monitor is designed as a portable device, with the operator usually standing by the patient's bed and holding the device in their hands. 1. The first line of data shows time (hour, minute)/patient ID, patient type: Adult or pediatric, the memory area full indicator （...

  • Page 24: Alarm Setting

    patient ID. Alternatively, select AUTO LOOP to overwrite the oldest data when memory is full , please see the details in 5.9 NEW PATIENT 2.) If the symbol appears, the menu is locked, the setting menu will be ▼ disabled unless user press the three buttons at the same time, or enters engineer menu to unlock the menu（Refer to Appendix 2.

  • Page 25: Alarm Delay

    Physiological alarm refers to the alarm causing by physiological change of patient, patient’s life may in danger. Technical alarm refers to system fault which cause Capnograph and Oximeter working unproperly. This Capnograph and Oximeter adopt only medium priority alarm. Medium priority alarm means serious warning. Physiological alarm includes physiological parameters exceeding alarm limits, APNEA alarm.

  • Page 26: Alarm Indication

    seconds. The sum of the mean ALARM CONDITION DELAY plus the mean ALARM SIGNAL GENERATION DELAY is less than 5 seconds. Alarm indication: 1.) If the EtCO ’s value exceeds the limit of high or low alarm level, the data will be yellow and flashing and alert with alarm.

  • Page 27: Alarm Light

    1 m from the “Beep-Beep-Beep”, Medium priority geometric triggered each 8 45～70dB alarm center of the seconds device Alarm light: Alarm light looks like following description. Level of alarm Light Intermediate Parameter data turn yellow, the screen will show ' ', and alarm blinking with frequency of 0.5Hz...

  • Page 28: Initial Monitoring Screen

    ’ flashing once on the screen and hear a beep, it indicates that the system alarm function is normal. 5.2 Initial Monitoring Screen Long press (about 3 seconds) power key " " to start the monitor, the initial monitoring screen is as shown below: Figure 5.2 In this menu, press ▲...

  • Page 29: The Main Menu

    5.3 The Main Menu Figure 5.3 Press the MENU button to enter the Main Menu to set monitor parameters ：All Menu Settings are LATCHING and remain when the WARNING Monitor is powered off. Ensure that all necessary settings are reviewed and are suitable for the patient BEFORE use.

  • Page 30: Co Set Menu

    5.4 CO SET Menu Figure 5.4 In this menu, press ▲ or ▼button to move the cursor up or down, press + button or - button to change the data highlighted by the cursor. To return to the main menu highlight EXIT and press the ENTER button. If you want to return the monitor to its default settings highlight LOAD DEFAULTS and Press the ENTER button.
  • Page 31 12.) EtCO average computation time: EtCO Averaging: every breath, 10sec, 20sec, 30sec 13.) Default reload: LOAD-DEFAULTS 14.) Exit: EXIT Attention: Pump auto-closing time means that the pump will automatically be closed down when no respiration occurs in the set period (default 10 min). The wave scale means the maximum value of waveform amplitude display but it does not mean data on full-scale.

  • Page 32: Spo Set Menu

    5.5 SpO SET Menu Figure 5.5 In this menu, press ▲ or ▼button to move the cursor up or down, press + button or - button to change the data highlighted by the cursor. To return to the main menu highlight EXIT and press the ENTER button. If you want to return the monitor to its default settings highlight LOAD DEFAULTS and Press the ENTER button.

  • Page 33: Time Set Menu

    Pulse Rate alarm low limit: 50bpm Curve: Line 5.6. TIME SET Menu Figure 5.6 In this menu, press ▲ or ▼button to move the cursor up or down, press + button or - button to change the data highlighted by the cursor. Attention: Any time adjustment will delete any stored trend data, so please take care before making this adjustment.

  • Page 34: Sound Set Menu

    Figure 5.7 5.7. Sound SET Menu Figure 5.8 In this menu, press ▲ or ▼button to move the cursor up or down, press + button or - button to change the data highlighted by the cursor. This menu includes following setups: Pulse sound volume: BEEP_VOLUME: 0(OFF)-8 Alarm sound volume: ALARM_VOLUME: 0(OFF)-8 Page 34 of 60...

  • Page 35: Trend

    5.8. Trend The graph trend Figure 5.9 The monitor stores EtCO2, PR, SpO2 and PR as a group of data every 12seconds (Adjustable in Store Interval under New Patient menu) with accumulated trend up to 24hours respectively. The stored data is retained even the device is shut off. The symbol will appear on screen when the storage is full.
  • Page 36 turns on the device once or more times the trend table will show one or several blue vertical lines with full amplitude, at this time press ▼, then the top row will display the initial information at that turn on time: patient’s ID number and initial time.

  • Page 37: New Patient Menu

    Press /▲button again, to return to graph trend . Every trend table shows 20 groups of data, including time, EtCO (Et), respiration rate (RR), SpO , pulse rate (PR). The store interval is adjustable at 12econds in STORE INTERVAL under NEW PATIENT menu. There are 24 sum pages when the storage is full.
  • Page 38 3.) ID: patient’s ID, press "Enter" key to enter or exit from the Set menu. Press + button or - button to move the cursor up or down，press ▲ or ▼button to change the data highlighted by the cursor. 4.) TYPE: patient type, Adult or pediatric options 5.) STORE INTERVAL: adjustable at 4/6/12 seconds 6.) POWER ON ID PROMPT: to set if the monitor enters into the "input new patient"...

  • Page 39: Charging, Maintenance, Cleaning

    6 Charging, Maintenance, Cleaning 6.1 Charging Connect the AC/DC power adapter via the Mini USB port turn on the unit. The unit will charge the battery with power at the same time as operating. The battery charge will end after battery is full. The battery of this unit is a long life rechargeable lithium battery.

  • Page 40: Maintenance

    6.2 Maintenance If the monitor appears abnormal (e.g. software system is halted), then to reboot the device hold the Power ON/OFF button down for 5 seconds. OCCLUSION: If the Display shows ‘occlusion', check if the filter and/or sampling line tubing or connectors are blocked. Replace as necessary and clear the occlusion or switch OFF to prevent damage to the sampling pump.
  • Page 41 1.) Cleaning the Monitor It is recommended that the Monitor is used in the supplied Carry Case which offers protection from both contamination, liquid ingress and damage. Do not sterilize by high pressure, autoclave or washer Do not dip or expose to liquid Do not use the Monitor if there is any sign of damage Use only PH Neutral Cleaning products.

  • Page 42: Trouble Shooting Analysis

    7 Trouble Shooting Analysis Simple analysis of problems Phenomena Causes Solution The values of CO is reading 1.Leaking of filter or 1. Check and replace too low, or 'OCCLUSION' sampling tube filter or sample line appears on the screen. 2. Occlusion of filter or 2.
  • Page 43 4. Red light in the 5.Clean internal parts sensor no flashing. of SpO Sensor 5. Infrared and collector of sensor is not clean Flashing red color 1. No Battery Charge. 1. Connect to Battery closed down automatically. Charger. Still flashing red color 1.

  • Page 44: Appendix 1. Explanations Of Terms In This Manual

    Appendix 1. Explanations of Terms in this Manual MENU Menu EtCO The CO concentration of expiration end phase FiCO The CO concentration of inspiration phase Oxygen saturation Respiration rate Pulse rate mmHg Millimeters Mercury Kilopascal ALARM-H Alarm high limit ALARM-L Alarm low limit LINE Line curve...

  • Page 45: Appendix 2. Changing Compensation Of Balance Gas

    Appendix 2. Changing compensation of balance gas Attention: Only the trained personnel may carry out the following the procedure. Contact your Supplier for training and advice. Enter the engineer menu as follows: and ▼ two buttons simultaneously to enter the following menu. Press Figure A2.1 In this menu, press ▲...
  • Page 46 MENU: UNLOCK, LOCK LOAD DEFAULTS CALIBRATE Attention: 1.) When the menu is locked, this menu is disabled. To unlock the menu, press + and ▼ to enter engineer menu and change “unlock” to “lock” in the MENU setting. This is to avoid the misoperation of the patient against the preset of the doctor. 2.) CALIBRATE is for CO concentration recalibration.

  • Page 47: Appendix 3. Calibration Of Etco 2 Accuracy

    Appendix 3. Calibration of EtCO Accuracy Attention: Only trained personnel are allowed to carry out the following procedure. Contact your Supplier for training and advice. The monitor has been calibrated before being shipped by the manufacturer. Generally the user does not need to calibrate this device other than the recommended annual check.
  • Page 48 Figure A3.1 3. Warm-up Turn on power and run the unit for 20-30 minutes and adjust the pump flow rate to over 120cc/min. To check if there is a leak use the following method: Squeeze the sampling tube by hand, the operating noise of the sampling pump will increase noticeably.
  • Page 49 Figure A3.2 Highlight STANDARD GAS and adjust the value to that of the concentration of standard gas. If the standard gas concentration precision is to 2 decimal places numbers round up accordingly. Then highlight CAL-BEGIN and long press the ENTER button for 8 seconds, at the same time, open the standard gas and the device will begin to calibrate.
  • Page 50 the calibration is unsuccessful. If you require to exit this menu during the calibration press the MENU button or highlight CANCEL and press the ENTER button. Note: Remember to close the valve of the standard gas to prevent wastage. Page 50 of 60...

  • Page 51: Appendix 4. Part Numbers And Consumables Listing

    Appendix 4. Part Numbers and Consumables listing CR-ASK900B Intubated Adult/Paediatric Airway Sampling Kit s x 10 Pack - each kit includes 1 of each item: Water Trap/Filter T3 for PC-900B Monitor Circuit Adaptor, 22F/15M with Gas Sample Port Gas Sampling Tee, Male/Male Luers, 1.27mm ID x 3.0m...
  • Page 52 CR-12VDC9B 12V DC Vehicle Power Adapter to 5V DC Mini USB 3m length Pack of 1 PROBAG-CAP Heavy Duty Cushioned Carry Case for PC-900B Monitor Pack of 1 Warning: PLEASE USE ONLY GENUINE RECOMMENDED SPARE PARTS AND ACCESSORIES OTHERWISE YOUR WARRANTY WILL BE INVALIDATED...

  • Page 53: Appendix 5. Guidance And Manufacturer's Declaration

    Appendix 5. Guidance and manufacturer’s declaration - Electromagnetic compatibility Table 1 Guidance and manufacturer’s declaration-electromagnetic emission-for all EQUIPMENT AND SYSTEMS This device is intended for use in the electromagnetic environment specified below. The customer or the user of the equipment or system should assure that it is used in such an environment. Emissions test Compliance Electromagnetic environment-guidance...
  • Page 54 Table 2 Guidance and manufacturer’s declaration-electromagnetic immunity for all EQUIPMENT AND SYSTEMS This device is intended for use in the electromagnetic environment specified below. The customer or the user of the equipment or system should assure that it is used in such an environment.
  • Page 55 0 % UT 0 % UT interruptions typical commercial or (100 % dip in UT) (100 % dip in UT) voltage hospital for 1 cycles for 1 cycles variations 70 % UT 70 % UT environment. If the (30 % dip in UT) (30 % dip in UT) power supply...
  • Page 56 Table 3 Guidance and manufacturer’s declaration – electromagnetic immunity-for EQUIPMENT and SYSTEM that are not LIFE-SUPPORTING This device is intended for use in the electromagnetic environment specified below. The customer or the user of this device should assure that it is used in such an electromagnetic environment.
  • Page 57 Table 4 Recommended separation distances between portable and mobile RF communications equipment and the equipment or system-for EQUIPMENT and SYSTEM that are not LIFE-SUPPORTING Recommended separation distances between portable and mobile RF communications and the device equipment This device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.
  • Page 58 equipment and result in improper operation. The following types of cable must be used to ensure compliance with interference remissions and immunity standards. Table 5 overview of cable Length of cable Shielded Name Remark (Yes or No) Power adapter cable Probe cable ⚫...
  • Page 59 Manufacturer Date of manufacture Lot number Follow instructions for use Keep in a cool, dry place Imported by Product code Authorized representative in the European community WEEE disposal This item is compliant with Directive 93/42/EEC Caution: read instructions (warnings) carefully Keep away from sunlight IPX1 Covering Protection rate...
  • Page 60 GIMA WARRANTY TERMS The Gima 12-month standard B2B warranty applies. 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.

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