Gima PC-300 User Manual
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Gima PC-300 User Manual

Spot-check monitor
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PROFESSIONAL MEDICAL PRODUCTS
MONITOR SPOT-CHECK PC-300
PC-300 SPOT-CHECK MONITOR
MONITEUR SPOT-CHECK PC-300
MONITOR SPOT-CHECK PC-300
Manuale d'uso - User manual
Manuel de l'utilisateur - Guía de Uso
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.
35162
Gima S.p.A.
Via Marconi, 1 - 20060 Gessate (MI) - Italy
Made in China
Gima S.p.A.
Via Marconi, 1 - 20060 Gessate (MI) Italy
gima@gimaitaly.com - export@gimaitaly.com
www.gimaitaly.com
0476

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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 MONITOR SPOT-CHECK PC-300 PC-300 SPOT-CHECK MONITOR MONITEUR SPOT-CHECK PC-300 MONITOR SPOT-CHECK PC-300 Manuale d’uso - User manual Manuel de l’utilisateur - Guía de Uso ATTENZIONE: Gli operatori devono leggere e capire completamente questo manuale prima di utilizzare il prodotto.
  • Page 2 ENGLISH Instructions for User Dear Customers, Thank you for purchasing the PC-300 Spot-Check Monitor. Please read the following informa- tion before using the device. These instructions describe the operating procedures which are to be strictly followed, read these instructions carefully before using the Spot-Check Monitor. Failure to follow these in- structions can cause monitoring abnormalities, damage to the monitor and personal injury.
  • Page 3 ENGLISH tation and as a result this can cause potential danger to the user.  Although biocompatibility tests have been performed on all the applied parts, under excep- tional circumstances, allergic patients may have anaphylaxis. Do NOT use the monitor on patient with anaphylaxis.

  • Page 4: Table Of Contents

    ENGLISH Table of contents Chapter 1 OVERVIEW ......................61 Features ......................61 Product Name and Model .................. 62 Intended Use ...................... 62 Impact on the Environment and Resources ............63 Chapter 2 OPERATION INSTRUCTIONS ................63 Appearance ......................63 2.1.1 The Front Panel ..................63 2.1.2 The Right and Upper Sides of the Device ..........
  • Page 5 ENGLISH History Data Review Screen ................93 Data Uploading ....................94 Chapter 4 TECHNICAL SPECIFICATIONS ................ 94 Blood Pressure Measurement ................94 Measurement .................... 95 Pulse Rate Measurement ................... 97 Temperature Measurement ................. 97 Blood Glucose Measurement (Optional)............. 97 ECG Measurement (Optional) ................97 Others .........................

  • Page 6: Chapter 1 Overview

    ENGLISH Chapter 1 OVERVIEW 1.1 Features • Small in size, light in weight, easy to carry and operate; • Clear and large numeric display, segmented LCD panel, real-time clock display; • Accurate blood pressure measurements can be activated or canceled by one shortcut button; •...

  • Page 7: Product Name And Model

    ENGLISH 1.2 Product Name and Model Name: PC-300 Spot-Check Monitor Model and Configuration: Configuration Model NIBP Pulse rate Temperature Blood Display Glucose √ √ √ √ √ PC-300 NOTE: 1. Spot-Check Monitor can configure with ECG and blood glucose function, details see the User Manual for Easy ECG Monitor and Glucose Meter respectively.

  • Page 8: Impact On The Environment And Resources

    ENGLISH 1.4 Impact on the Environment and Resources Chapter 2 OPERATION INSTRUCTIONS 2.1 Appearance 2.1.1 The Front Panel Description: 1/2. up/down key: on the setup display screen, a short press will change the parameter value step by step, press and 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.
  • Page 9 ENGLISH can be set in anticlockwise order by pressing and holding , key, similarly, a short press of key will set the parameters in clockwise order. Menu key: on the measurement display screen, press and hold the menu key to enter the setup screen;...

  • Page 10: The Right And Upper Sides Of The Device

    ENGLISH 2.1.2 The Right and Upper Sides of the Device Figure 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 side of the monitor as shown in figure 2.3.
  • Page 11 ENGLISH Description: : External DC power input socket. : Power switch: = press and hold to turn on/off monitor. 3. Battery cover. : Charge / USB data interface. : Connector to link with the blood glucose meter. 6. NIBP: Cuff connector. 7/8.

  • Page 12: Installation

    ENGLISH Description: : External DC power input socket. : Power switch: = press and hold to turn on/off monitor. 3. Battery cover. : Charge / USB data interface. Figure 2.3B Upper-side view 5. GLU : Connector to link to the blood glucose meter.

  • Page 13: Starting The Monitor

    ENGLISH When the battery indicator displays full grids, the built-in battery is fully charged. When it blinks, the battery voltage is low, and the user should charge the battery by connecting the device to the AC power adapter or a USB power source via USB cable. When the grids of the battery indicator are rolling circularly, the battery is being charged.

  • Page 14: Downloading App Software Onto Android Smart Phone

    ENGLISH 2.2.3 Downloading APP software onto Android smart phone Terminal devices such as Android smart phones can be used to receive data from the Spot- Check Monitor in real-time, store the received data, and also review the stored data. To use this function, download the corresponding APP software onto the smart phone device.

  • Page 15: Taking Measurement

    ENGLISH 2.3 Taking Measurement 2.3.1 Blood Pressure Measurement 1. An appropriate cuff should be selected according to the age and arm circumference of the patient. The cuff width should be 2/3 of the length of the upper arm. The inflatable part should be long enough to permit wrapping approximately 80% of the limb.
  • Page 16 ENGLISH , which means that the adult’s blood pressure result is normal. Please re- fer to the form below for detailed blood pressure levels. Note: blood pressure level indication is only for "Adult" patient type. Level Blood pressure range (Unit: mmHg) N (Normal) SIS <130mmHg, and DIA <85mmHg H-N (High normal)
  • Page 17 ENGLISH Safety Instructions for blood pressure measurement  Blood pressure measurement is prohibited to those who have severe hemorrhagic tenden- cies or with sickle cell disease, as partial bleeding maybe caused.  Too frequent measurements or connection tube kinking may result in purpura, neuralgia and lack of blood.

  • Page 18: Spo Measurement

    ENGLISH  Avoid compressing or restricting the connection tubing.  The patient should be comfortably seated with their legs uncrossed and feet flat on the floor. The patient's back and arm should be supported, and the middle of the cuff should be level with the right atrium of the heart.
  • Page 19 ENGLISH connector, be sure to hold the head of the connector firmly and pull. 2. The red blinking light inside the clip of the SpO probe indicates a successful connection. 3. Insert one finger (index finger is preferred, the nail should be not too long) into the clip of the probe according to the finger mark shown as below.
  • Page 20 ENGLISH same place for over two hours, change the measurement site periodically and when neces- sary.  Do NOT place the SpO probe on a finger with edema or fragile tissue.  When the ambient temperature is over 35°C, please change the measuring site every two hours;...

  • Page 21: Temperature Measurement

    ENGLISH 2.3.3 Temperature Measurement The infrared temperature probe is a delicate transducer. To operate please follow these steps and procedures. Failure to accurately operate may cause damage to the probes 1. The infrared temperature probe Please place the infrared temperature probe in a stable ambient temperature for 30 minutes before taking a measuring.
  • Page 22 ENGLISH displays , this indicates that the probe is successfully connected. 2. When the screen shows as figure 2.7B and the temperature unit "°C" is blinking, the user can begin to take the measurement. 3. Insert the tip of the temperature probe into the earhole and press the measuring key to start the measurement.
  • Page 23 ENGLISH Besides, each person has his/her own normal temperature value, and the normal temperature value also changes at different time within a day. Therefore, it's recommended to report your doctor not only the temperature value, but also the measuring position, if possible you may provide your own normal temperature range to your doctor for reference.

  • Page 24: Blood Glucose Measurement (Optional)

    ENGLISH 2.3.4 Blood Glucose Measurement (Optional) Using the optional link cable for the On Call Plus Blood Glucose Meter, connect the Glucose Meter to the connector on the right side of the Spot-Check Monitor marked "GLU” Appearance and key functions of the On Call Plus Blood Glucose: 1.
  • Page 25 ENGLISH Operations for the Lancing Device and Blood Lancet Cocking barrel Lancet holder Sterile lancet Cocking barrel Release button Safety tab Puncture depth Lancing device cover settings 1. Unscrew the lancing device cover from the body of the lancing device. Insert a sterile lancet into the lancet holder and push it until the lancet comes to a complete stop in the lancet hol- der.
  • Page 26 ENGLISH Figure 2.9A Operation for Lancing Device and Blood Lancet Quick operation procedure for On Call Plus Glucose Meter: 1. Insert a new test strip into the strip slot, contact bars end first and facing up, to turn on the meter and display all the display segments.
  • Page 27 ENGLISH Figure 2.9B Testing instruction Refer to the provided User Manual of the “On Call Plus Blood Glucose Monitoring System” for further detailed instructions. Safety Instruction for Blood Glucose Measurement  The provided test strips should be used with the On Call Plus Glucose Meter. ...

  • Page 28: Ecg Measurement (Optional)

    ENGLISH  Do NOT press or scrape the bleeding finger.  The testing strip should be used as soon as possible after unpacking, and the unused strips should be kept in the bottle with airproof condition.  Take measurement only once within 1 min. ☞...
  • Page 29 ENGLISH 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...
  • Page 30 ENGLISH To obtain a clear and high quality ECG signal, the lead wire measurement can be used. Connect the lead wire firmly to the lead wire socket of the device. Place the electrodes and connect the lead wires as shown in Figure 2.10E to obtain the Lead II ECG signal. If you want to measure Lead I and Lead III ECG signal, connect the lead wires to the electrodes (Note: lead wire is op- tional) as detailed in table below.

  • Page 31: Blood Pressure Accuracy Check Method

    ENGLISH Table 1 ECG Leads Configuration and Electrodes Location Table Electrode Lead Lead I Lead II Lead III Name & Color Electrode Location The intersection between the centerline R (Red)/ R (Red)/ L (Yellow)/ of the right clavicle and Rib 2. RA (White) RA (White) LA (Black)
  • Page 32 ENGLISH 4. Connect the NIBP connector end to the NIBP port on the Spot-Check Monitor as shown in figure 2.14. 5. Turn on the Spot-Check Monitor. Press the menu button to go to the settings. Press and hold the large NIBP measurement button to enter the Pressure Check Mode. 6.

  • Page 33: Symbols

    ENGLISH 2.5 Symbols Symbol Description Symbol Description Symbol Description External DC power Wireless Keep in a cool, dry place input Charger or USB Data interface / Alarm Keep away from sunlight Connector to link with blood glucose meter Follow instructions for Memory icon Date of manufacture Power on/off switch...

  • Page 34: Chapter 3 Monitoring Screen Display

    ENGLISH Chapter 3 MONITORING SCREEN DISPLAY 3.1 Measuring Screen Screen Description: USB connection icon wireless transmission icon; means that the wireless transmission function is on; when the icon is blinking, the wireless connection set up is unsuccessful; when this icon is steady, the wireless connection set up is successful;;...
  • Page 35 ENGLISH When the indicator is blinking, it means the battery voltage is low and the user should charge the battery. Please connect the device to the external power supply to ensure the correct use of the monitor, and the battery will be charged. During charging, the grids in the battery indi- cator with roll circularly.

  • Page 36: System Setting Screen

    ENGLISH the heart beat symbol which flashes with heart beat. 23. TEMP/GLU: the current displayed temperature with an option of °C for Celsius, or °F for Fahrenheit. When the optional GLU (Blood glucose) is chosen, the blood glucose value will be displayed with the default unit of mmol/L.
  • Page 37 ENGLISH in the order of anti-clockwise by pressing and holding the , key, the order will be: ID ’ Minute ’ Hour ’ Day ’ Month ’ Year ’ TEMP ’ NIBP unit ’ Alarm sound ’ Wireless transmission function ’ NIBP mode). 3.

  • Page 38: History Data Review Screen

    ENGLISH 3.3 History Data Review Screen On the measurement display screen, press and hold key to recall the stored data records, as shown in figure 3.3. Operation instructions: 1. Press and hold the , key, release the key after hearing one beep. The memory mark" will appear (i.e.

  • Page 39: Data Uploading

    ENGLISH 3.4 Data Uploading 1. When the wireless transmission function is on, the monitor can communicate with a host device such as a PC, smart phone or other wireless enabled devices for real-time data tran- smission. 2. When connected to a USB cable, the history data can be uploaded to a PC for viewing and management.

  • Page 40: Spo 2 Measurement

    ENGLISH 4.2 SpO Measurement 1 Technique: optical with dual-wavelength LED wavelength: Red light: 663nm, Infrared light: 890nm Maximal optical output power: less than 2mW maximum average 2. SpO display range: 0%~100% 3. SpO measuring accuracy: Arms is not greater than 3% for SpO 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 /...
  • Page 41 8. The graphical plot of all sampled data points: 9. Note: The data 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 SpO measurement technology provided in the subject device.

  • Page 42: Pulse Rate Measurement

    ENGLISH 4.3 Pulse Rate Measurement 1. PR measuring range: 30bpm~240bpm 2. Pulse rate measuring accuracy: ±2bpm or ±2%, which is greater 4.4 Temperature Measurement 1. Measuring range: 32.0°C~43.0°C 2. Measuring accuracy: ±0.2°C is for TEMP range from 36.0°C to 39.0°C, and ±0.3°C is for the rest;...

  • Page 43: Others

    ENGLISH 4.7 Others 4.7.1 Operating Environment 1 Operating temperature: 5°C~40°C; Relative humidity: 30%~80%; Atmospheric pressure: 70.0kPa~106.0kPa; Power supply: a.c. 110V-240V AC, 50/60Hz; Internal power supply: d.c.3.7V (rechargeable Lithium battery); Input: 15VA 2. The device should be situated in a place protected against direct sunlight, to prevent overhe- ating inside of the equipment.

  • Page 44: Classification

    ENGLISH • The device may not function properly due to the strong magnetic and radiofrequency fields generated by the MR scanner. Warning: Do not use any other adapters than those provided. 4.7.2 Classification 1. Protection against electric shock: Class II equipment and internally powered equipment 2.

  • Page 45: Chapter 5 Troubleshooting

    ENGLISH Chapter 5 TROUBLESHOOTING Trouble Possible reason Solution Ca not turn on the device The built-in battery is drained Recharge by connecting the power supply adapter Battery is not installed Install the Lithium battery Some parts provided by other manufactu- Remove the related parts and try again res are inserted to the connector No blood pressure result...

  • Page 46: Chapter 6 Error Message Interpreting

    ENGLISH Chapter 6 ERROR MESSAGE INTERPRETING Error code Description ERR 01 Fails to inflate pressure to 30mmHg within 7 seconds (The cuff is not well-wrapped) ERR 02 Cuff pressure is over 295mmHg (Overpressure protection) ERR 03 No valid pulse is detected ERR 04 Excessive motion artifact ERR 05...

  • Page 47: Chapter 7 Packing List

    ENGLISH Chapter 7 PACKING LIST Item Description Quantity Check Spot-Check Monitor One piece Handbag One piece User Manual One piece Cuff One piece USB cable One piece Charger (with USB socket) One piece Temperature probe One piece Smart SpO probe One piece Glucose Meter (with lancing device and link cable )

  • Page 48: Chapter 8 Maintenance And Service

    ENGLISH Chapter 8 MAINTENANCE AND SERVICE The Spot-Check Monitor should be properly maintained to ensure its maximum performance and long service life. In addition to the warranty period, the company also offers long-term ser- vice for each customer. It is important that the user reads and follows the operation instructions, important information and maintenance measures.

  • Page 49: Battery Maintenance

    ENGLISH  The SpO function has been adjusted before vending. If the user needs to adjust the SpO adjust by using the simulator mode FLUKE INDEX2.  The adjustable units in the monitor such as the potentiometer cannot be adjusted without permission so to avoid unnecessary failures that may affect the normal application.

  • Page 50: Cleaning And Disinfection Of The Main Unit

    ENGLISH automatic and seamless.  If the battery is damaged, please replace it with a battery with "CCC" or "CE" mark. The model and specifications of the battery should be the same as the original battery. The user must ensure that the battery meets all applicable safety codes. The user can also contact the distributor for service.

  • Page 51: Cleaning And Disinfection Of Accessories

    ENGLISH  Do NOT pour disinfectant on the monitor's surface while disinfecting. 8.3 Cleaning and Disinfection of Accessories It is recommended to clean and disinfect the accessories (excluding the SpO probe) with a piece of gauze soaked in 75% Alcohol or 70% Isopropanol. ...

  • Page 52: Transportation

    ENGLISH 8.5 Transportation The monitor should be transported by land (vehicle or railway) or air in accordance with the contractual terms. Do NOT hit or drop with force. Appendix I Classification of Blood Pressure Level Category SYS (mmHg) DIA (mmHg) Optimal <120 <80...
  • Page 53 The warranty is valid for 12 months from the date of supply of GIMA. During the period of validity of the warranty, GIMA will repair and/or replace free of charge all the defected parts due to production reasons.

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