Gima PC-900B User Manual Download

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PROFESSIONAL MEDICAL PRODUCTS

Gima S.p.A.

Via Marconi, 1 - 20060 Gessate (MI) Italy

[email protected] - [email protected]

www.gimaitaly.com

CAPNOGRAPH AND OXIMETER

PC-900B

User manual

ATTENTION:

The operators must carefully read

and completely understand the present manual

before using the product.

M33698-GB-Rev

.1.05.18

Shenzhen Creative Industry Co., Ltd. 2/F Block 3

Nanyou Tian’an Industry Town - 518054 Shenzhen, GD - P.R.C.

Made in China (P.R.C.)

Shanghai International Holding Corp. GmbH (Europe)

Eiffestrasse 80, 20537 Hamburg, Germany

33698 / PC-900B

0123

Summary of Contents for PC-900B

Page 1: ...ser manual ATTENTION The operators must carefully read and completely understand the present manual before using the product M33698 GB Rev 1 05 18 Shenzhen Creative Industry Co Ltd 2 F Block 3 Nanyou Tian an Industry Town 518054 Shenzhen GD P R C Made in China P R C Shanghai International Holding Corp GmbH Europe Eiffestrasse 80 20537 Hamburg Germany 33698 PC 900B 0123 ...

Page 2: ...lly and then follow its instructions when operating this monitor It is not permitted to open the monitor s main cover modify or disassemble it without our permission or official service training The buyer will not be advised of Technology updates which do not influence the monitor s key functionality Furthermore please pay attention to the difference between the parts or components provided as inf...

Page 3: ...or 7 Chapter IV Patient connection 9 Chapter V Screen display and Operation 13 Chapter VI Charging Maintenance Cleaning 23 Chapter VII Trouble Shooting Analysis 25 Appendix 1 Explanations of Terms in this Manual 26 Appendix 2 ENGINEER MENU Changing compensation of balance gas 27 Appendix 3 Calibration of EtCO2 Accuracy 28 ...

Page 4: ... monitor is damaged due to misuse or incorrect operation i e without following the User manual instruction the monitor is damaged due to incorrect connection with another instrument the monitor is accidentally damaged or dropped if the user modifies or changes the monitor without written authority of the company the serial number is deliberately damaged torn off or unreadable Maintenance If the mo...

Page 5: ... proprietary non dispersive InfraRed Spectroscopy Range 0 150mmHg or 0 20kPa or 0 20 v v Accuracy 2mmHg for EtCO2 range 0 40mmHg 5 for EtCO2 range from 41 70mmHg 8 for EtCO2 range from 71 100mmHg Over 100mmHg 10 Note The accuracy of CO2 concentration measurement is influenced by any interfering gas and or vapour for example N2O gas can raise the CO2 reading 2 10 and Helium and O2 can reduce the CO...

Page 6: ...ter Cable Optional Vehicle 12V to 5V Mini USB Charger Lead Battery Type Built in rechargeable lithium battery pack 3 6V 3000mAH Charging Time 4 hours from flat Operating Time 10 hours on full charge Operating Conditions Temperature 5 to 50 C Humidity 93 non condensing 29 45 hPa Atmospheric pressure 70 120 kPa Storage Conditions Temperature 30 to 70 C Relative Humidity 93 non condensing Atmospheric...

Page 7: ... per IEC 60601 1 CSA601 1 UL2601 1 Type of Protection Class II Degree of Protection Type BF Applied Part Mode of Operation Continuous 93 42 EEC Medical Device Directive Compliant CE 0123 Shenzhen Creative Industry Co Ltd Chapter III Introduction of Monitor I Introduction Figure 1 ...

Page 8: ...as automatically time switched OFF c If the device is connecting with Bluetooth printer press this button for 2 seconds to print capnography and other result parameters EtCO2 RR SpO2 PR 7 Press this button to enter or quit menu or change display 8 Power button hold for 2 seconds to activate 9 Indicator POWER Blue LED is lit when the Monitor is either switched ON or subject to external power when n...

Page 9: ...Use a Male to Male Luer adapter if necessary and then select a sampling point as close as possi ble to either the Patient or the Ventilator Breathing Circuit Figure 2 Filter water trap T3 WARNING Do not use the Monitor if the filter water trap T3 is not installed to avoid contamination and damage to the IR measurement cell In order to avoid vapor and respiratory mucus entering into the IR Cell the...

Page 10: ...ent or Ventilator Circuit 4 Change the filter water trap T3 as needed This item may dried if very wet and re used subject to local Infection Control requirements If the filter water trap T3 becomes dirty or the Occlusion Alarm is activated when it is dry then the filter water trap must be replaced WARNING Ensure that connections are air tight as if there is leakage measured values are likely to be...

Page 11: ...e thereby improving the accuracy of the waveform PLEASE NOTE that if the filter water trap becomes full of water or dirt the display will show OCCLUSION the operator needs to change the filter water trap T3 The old filter can be reused after natural drying in a ventilated and dry environment Discard the old filter water trap if dirty IV Oxygen saturation measurement optional 1 It is also recommend...

Page 12: ...nt information 1 CO2 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...

Page 13: ...systole occur the pulse signal may disappear Chapter V Screen display and Operation I Screen main display menu Figure 5 The first line of data shows time hour minute patient ID patient type Adult ADU or Neonate NEO the memory area full indicator alarm sound closing silence or non silence bluetooth symbol and battery indicator Attention a When the memory full indicator is displayed further patient ...

Page 14: ... the unprotected IR detector Cell Alarm indication 1 If the EtCO2 s value exceeds the limit of high or low alarm level the word EtCO2 will flash and alert with the audible high priority alarm This high priority alarm will also sound for respiration rate SpO2 and pulse rate alarms 2 If the battery level is almost fully depleted the battery indicates completely empty the monitor will alarm continuou...

Page 15: ...FORE use This menu includes the following options The setting menu for CO2 CO2_SETUP The setting menu for SpO2 SpO2_SETUP The trend menu TREND The time menu TIME_SETUP The sound menu SOUND_SETUP The new patient menu NEW PATIENT In this menu to press or button to move the cursor up or down to highlight an option and Press the ENTER button to select and enter the next level of the menu To return to ...

Page 16: ...f respiration rate RESP ALARM_H 5 60 breaths min off 4 The low alarm limits of respiration rate RESP ALARM_L off 4 40 breaths min 5 Pump flow rate setup FLOW SET 50cc min 250cc min 6 The setup of apnea time APNEA TIME 15s 44s off 7 The unit of CO2 CO2 UNIT mmHg or kPa 8 Pump switch ON or OFF 9 Pump auto closing time AUTO OFF TIME 10 30min 10 Screen speed of capnograph SWEEP SPEED SLOW NORMAL or FA...

Page 17: ...eaths min FiCO2 alarm high limit OFF FLOW_SET 100 CC Min Apnea time 30S CO2 unit CO2_PUMP ON AUTO_OFF_TIME 10 Min SWEEP SPEED NORMAL EtCO2 Averaging 1 Breath WAVE SCALE 54mmHg IV SpO2 SET Menu Figure 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 To return to the main menu highlight EXIT and press the ENTER button If...

Page 18: ...th part of photoplethsmogram is filled LINE indicates the photoplethysmogram is drawn in curve line Default values as follow SpO2 alarm high limit 100 SpO2 alarm low limit 92 Pulse Rate alarm high limit 130 beats min Pulse Rate alarm low limit 50 beats min Curve Line V TIME SET Menu Figure 9 In this menu press or button to move the cursor up or down press button or button to change the data highli...

Page 19: ...e cursor and highlight NO and press Enter 4 Only by confirming can the time adjustments be made Figure 10 VI Sound SET Menu Figure 11 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 20: ...e storage is full There are three options to further store the data 1 Change patient ID under NEW PATIENT menu 2 Change store mode to AUTO under NEW PATIENT menu in auto mode data will be stored and renewed when reaches its limits 3 Select CLEAR MEMORY under NEW PATIENT menu to empty the stored data Figure 12 shows that the time base for the trend page is 1 hours and every point indicates the resu...

Page 21: ...nd on for several patients The time at beginning and ending parts of abscissa in this picture respectively indicates the beginning and ending time for trend of this page If the data is not complete it shows the monitor was turned off although it has not completed 2 hours record In this menu press ENTER button to change the trends of CO2 concentration respiration rate SpO2 and pulse the latter 2 pa...

Page 22: ... in Figure 13 In fully stored status 24 pages can be paged up or down by button or button The page no is indicated on right top of the screen in Figure 13 To quickly check if the four parameters of a data group are all zero the display will display the parameter columns in blue VIII NEW PATIENT Menu Figure 14 In this menu press or button to move the cursor up or down press button or button to chan...

Page 23: ...s possible After DC power is connected the monitor will recharge the battery and will stop charging after the battery has fully recharged Operation time for a fully charged unit is 10 Hours Charge time is approx 4 Hours Battery replacement method Note that the operation must be done with the DC Charger disconnected ensuring that the operator s safety is not compromised Press down and slide off to ...

Page 24: ...onment disposable sample line or filter shall be treated suitably or recycled III Cleaning Warning Before to clean the monitor and probe power shall be turned off and removed from any charging source 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 to sterilize the Monitor b...

Page 25: ...of problems No Phenomena Causes Solution 1 2 3 4 5 The values of CO2 is reading too low or OCCLUSION appears on the screen The values of CO2 is zero 1 Screen indicating PUMP ERR and big noise 2 Screen indicating IR LAMP BAD 3 Screen indicating CO2 SENSOR ERR Screen indicating CAL ERR Screen indicating POWER ERR The CO2 wave is not normal 1 Screen indicating TEMP HIGH 1 Leaking of filter or samplin...

Page 26: ... period of time Breaths Min Breaths per minute CAL Offset Calibration SET Setup 2 Screen indicating TEMP LOW 3 Screen indicating TEMP IMBALANCE No values of SpO2 or no wave Flashing LOW BATTERY and closed down automatically Still flashing LOW BATTERY after the power is supplied and AC indicator no light 1 Finger too cold 2 Interference of very strong external light 3 The measurement test of SpO2 a...

Page 27: ...ed personnel may carry out the following the procedure Contact your Supplier for training and advice Enter the engineer menu as follows Press and two buttons simultaneously to enter the following menu Figure 15 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 Some items of this menu can be directly adjusted such as LOAD ...

Page 28: ...ndix 3 Calibration of EtCO2 Accuracy Attention Only trained personnel are allowed to carry out the following procedure Contact your Supplier for training and advice 1 Attentive items and preparative work The monitor has been calibrated before being shipped by the manufacturer On each occasion that the monitor is switched on it will do a self check and gain adjustment according to working environme...

Page 29: ... of the Zero base vent the connections from the three way adapter and the monitor to outdoor 1 2 Connect as follows Figure 16 2 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 If the samplin...

Page 30: ... 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 as set per Figure17 and the device will begin to calibrate The screen will display the message ADJUSTING as sown in FIGURE 18 Figure 18 The thick cross bars in the display will be erased as time passes and the calibration will end when they are ...

Page 31: ...e is a leak or standard gas has run out the pressure indicator of gas bottle shows 0 The Calibration menu will remain if 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 32: ... the warranty GIMA will repair and or replace free of charge all the defected parts due to production reasons Labor costs and personnel traveling expenses and packaging not included All components subject to wear are not included in the warranty The repair or replacement performed during the warranty period shall not extend the warranty The warranty is void in the following cases repairs performed...

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