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Manuale d’uso - User manual 

Manuel de l’utilisateur - Guía de Uso

Gima S.p.A. 

Via Marconi, 1 - 20060 Gessate (MI) Italy

[email protected] - [email protected]

www.gimaitaly.com

35162

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.

ATENCIÓN: 

Los operadores tienen que leer y entender 

completamente este manual antes de utilizar el producto.

M35162-M-Rev

.4-07.19

Gima S.p.A.

Via Marconi, 1 - 20060 Gessate (MI) - Italy

Made in China

MONITOR SPOT-CHECK PC-300

PC-300 SPOT-CHECK MONITOR

MONITEUR SPOT-CHECK PC-300

MONITOR SPOT-CHECK PC-300

PROFESSIONAL MEDICAL PRODUCTS

0476

Summary of Contents for 35162

Page 1: ...ust carefully read and completely understand the present manual before using the product AVIS Les op rateurs doivent lire et bien comprendre ce manuel avant d utiliser le produit ATENCI N Los operador...

Page 2: ...The manufacturer s warranty service does not cover such faults Warnings Do NOT use the device under flammable gas condition or in any environment that may lead to explosion The device and accessories...

Page 3: ...ions as the accessories If the monitor falls off a surface accidentally please do NOT operate it before its safety and technical performance have been tested and positive results obtained Do NOT open...

Page 4: ...2 Installation 67 2 2 1 Power Supply 67 2 2 2 Starting the Monitor 68 2 2 3 Downloading APP software onto Android smart phone 69 2 3 Taking Measurement 70 2 3 1 Blood Pressure Measurement 70 2 3 2 SpO...

Page 5: ...1 Operating Environment 98 4 7 2 Classification 99 Chapter 5 TROUBLESHOOTING 100 Chapter 6 ERROR MESSAGE INTERPRETING 101 Chapter 7 PACKING LIST 102 Chapter 8 MAINTENANCE AND SERVICE 103 8 1 Technica...

Page 6: ...t infrared temperature probe ensures quick and accurate measurements of body tempe rature Blood pressure oxygen saturation pulse rate and temperature can be measured simultaneou sly Blood Glucose mete...

Page 7: ...nction is not available 1 3 Intended Use The Spot Check Monitor is a device designed for spot checking the user s physiological para meters such as non invasive blood pressure NIBP functional oxygen s...

Page 8: ...hold to change the parameter values quickly on the review display screen short press to review the history data records press and hold to recall the history data records quickly 3 Memory key on the me...

Page 9: ...key on the measurement display screen press and hold the menu key to enter the setup screen on the setup or review display screen press and hold the key to go back to the measurement display screen 5...

Page 10: ...gure 2 2 Figure 2 3A Vista lato superiore The power switch and external DC power input socket are on the right side of the monitor as shown in figure 2 2 The signal input output ports are on the upper...

Page 11: ...on device and Figure 2 3B is the upper side view for the current version device The difference between the two versions is seen on the upper side panel The previous version device has only 2 ports mar...

Page 12: ...USB data interface 5 GLU Connector to link to the blood glucose meter 6 NIBP Cuff connector 7 SpO2 Smart SpO2 probe connector 8 TEMP Temperature probe connector 9 ECG Connector to link with ECG access...

Page 13: ...rce with output capacity of 5Vdc 1 2A 2 2 2 Starting the Monitor By pressing and holding down the switch the software version will be displayed after relea sing the switch the device will enter the me...

Page 14: ...hen successfully scanned a web link for downloading the APP software will be displayed 4 Open the web link to download the APP software Install the software when successfully downloaded For terminal d...

Page 15: ...n is shown in figure 2 5 3 Connect the hose from the cuff to the connector on the upper side of the device where marked NIBP 4 Long press menu key to enter the setup screen select the proper patient c...

Page 16: ...ow within the upper arm then the cuff pressure is deflated slowly and all the change of cuff pressure in the deflation process is recorded to calculate blood pressure based on certain algorithm The de...

Page 17: ...he equipment can be used on pregnant or pre eclamptic patients The proper operating steps are needed to obtain accurate resting Blood Pressure reading routinely Patient position in normal state includ...

Page 18: ...lead to pressed arm reduced blood flow low blood pressure and result in an inaccurate reading It is recommended that the measurements are taken in intervals of more than two minutes Before use empty...

Page 19: ...unique hardware and software design By use of red and infra red light emitting through the patient s finger the photo detector at the other side senses the transmitted light and converts to current fo...

Page 20: ...use it further Remove nail polisher or other cosmetic products from the fingernail The fingernail should be of normal length The SpO2 sensor cannot be immersed into water liquid or cleanser The SpO2...

Page 21: ...robe in a stable ambient temperature for 30 minutes before taking a measuring Figure 2 7A sonda per la temperatura a infrarossi Figure 2 7B Operation procedure 1 Connect the infrared temperature probe...

Page 22: ...hardware failure the display screen on the infrared tempe rature probe will show Err and will not enter into measuring mode The infrared temperature probe will switch to stand by automatically if ther...

Page 23: ...the operating ranges specified by the manufacturer Performance of the device may be adversely affected when one or more of the following occur A Operation outside of the manufacturer specified subjec...

Page 24: ...od 2 Test strip slot a test strip is inserted into the slot to perform a test 3 LCD display display the test result and help you go through the testing process 4 M key recall previous test results fro...

Page 25: ...Save the safety tab for lancet disposal 3 Carefully screw the cover back onto the lancing device Avoid contact with the exposed nee dle Make sure the cover is fully sealed on the lancing device 4 Adj...

Page 26: ...r is turned on 2 The blinking test strip and blood drop icon will indicate that the test strip is inserted correctly and a drop of blood can be added 3 Touch the blood sample to the sample tip at the...

Page 27: ...used with the On Call Plus Glucose Meter Do NOT clean or disinfect finger with iodine The calibration code must be the same with what on the packaging The On Call Plus Glucose Meter will automaticall...

Page 28: ...stbin 2 3 5 ECG Measurement Optional 1 Connect the Easy ECG Monitor to the connector on the upper side of device marked ECG PORT1 or PORT2 for previous version of the device 2 Choose one of the method...

Page 29: ...84 Figure 2 10A Easy ECG Monitor Start Stop Start Stop ECG measurement Figure 2 10B Figure 2 10C Figure 2 10D Palm measurement Chest measurement Leg measurement ENGLISH...

Page 30: ...ctrodes Note lead wire is op tional as detailed in table below Safety Instructions for ECG Measurement 1 Check the device to make sure that there is no visible damage that may affect the user s sa fet...

Page 31: ...sure Accuracy Check Method Operation procedure 1 Unscrew the M3x6 screw from the battery compartment on the back of the Spot Check Mo nitor as shown in figure 2 11 2 Take a NIBP connector plug from th...

Page 32: ...ton to go to the settings Press and hold the large NIBP measurement button to enter the Pressure Check Mode 6 Start pumping and check if the pressure reading on the Spot Check Monitor matches the merc...

Page 33: ...onnector to link with blood glucose meter Memory icon Date of manufacture Follow instructions for use Power on off switch WEEE disposal Product code Type BF applied parts Pulse rate unit bpm beat per...

Page 34: ...when the icon is blinking the wireless connection set up is unsuccessful when this icon is steady the wireless connection set up is successful the wireless transmission function is off 3 Beep sound in...

Page 35: ...Nor mal H N High normal and HT hypertension 8 10 Indicates the NIBP measurement mode the indicator appears on the corresponding patient type for Adult for Child and for Infant 11 M memory 12 ID the p...

Page 36: ...splay screen as shown in figure 3 2 The user can choose the settings for the wireless function pulse beep blood pressure unit temperature unit date and time Operation Instruction 1 Press and hold the...

Page 37: ...4 A short press of the key confirms the setting 5 Press and hold the key brings the screen display back to the measurement display scre en The monitor will also switch back to the measurement display...

Page 38: ...tient s ID number will blink at the same time 2 A short press of the key will browse the patient s ID number 3 A short press of the key will confirm the setting and the recorded number No will blink 4...

Page 39: ...management Chapter 4 TECHNICAL SPECIFICATIONS 4 1 Blood Pressure Measurement 1 Technique Oscillometric 2 Pressure measuring range 0mmHg 300mmHg 3 Cuff inflation time 20 seconds typical adult cuff 4 O...

Page 40: ...pO2 range from 70 to 100 undefined during range 0 70 Note Arms is defined as root mean square value of deviation according to ISO 80601 2 61 ISO 9919 4 Measuring mode spot checking 5 SpO2 display upda...

Page 41: ...ta is obtained from UP 7000 K123711 which has the same technology as the PC 300 through a controlled induced hypoxia study which was conducted with healthy adult volunteers The device uses the same Sp...

Page 42: ...he rest 0 4 F is for TEMP range from 96 8 F to 102 2 F and 0 5 F is for the rest 3 Response time 5s 4 5 Blood Glucose Measurement Optional 1 Technique Amperometric glucose oxidase 2 Measuring range 1...

Page 43: ...ure humility and atmospheric pressure range or damage maybe caused to the device and as a consequence record inac curate results 5 If the device gets wet by accident the operator should NOT turn on th...

Page 44: ...on against electric shock Class II equipment and internally powered equipment 2 The degree of protection against electric shock Type BF applied part 3 Define apply part cuff SpO2 probe temperature pro...

Page 45: ...Wrap the cuff around the arm correctly The windpipe is not correctly inserted to the NIBP jack Insert the windpipe to the NIBP jack No SpO2 result The SpO2 probe is not plugged into the SpO2 connecto...

Page 46: ...e is detected ERR 04 Excessive motion artifact ERR 05 Invalid measured result ERR 06 Air leakage is detected ERR 07 Self test fail ERR 08 Pneumatic system error ERR 09 Signal saturation ERR 10 Air lea...

Page 47: ...Charger with USB socket One piece 7 Temperature probe One piece 8 Smart SpO2 probe One piece 9 Glucose Meter with lancing device and link cable One set 10 Blood glucose test strips with blood lances...

Page 48: ...out Check the monitor for any mechanical damage Inspect the exposed parts and the inserted parts of all the leads and the accessories Examine all the functions of the monitor that are likely to be use...

Page 49: ...spose of the battery according to local regulations do NOT throw into fire Do NOT hit or strike the battery with force Do NOT use this battery in other devices Do NOT use this battery below 20 C or ab...

Page 50: ...of the monitor and transducers with an alcohol impregnated wipe and dry with a clean cloth or just air dry Dilute the cleaner Do NOT use scrubbing materials The monitor can be disinfected Please clea...

Page 51: ...ter disinfection To prevent cross infection the user wipes the temperature sensitive probe with 75 alcohol before and after use then wipes the residue clean with clean dry cloth Disinfect the temperat...

Page 52: ...of Blood Pressure Level ENGLISH Category SYS mmHg DIA mmHg Reference The 1999 WHO ISH Guidelines for the Management of Hypertension Optimal 120 80 Normal 130 85 High normal 130 139 85 89 Grade 1 hype...

Page 53: ...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 subj...

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