Gima LS808-BS Manual
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Gima LS808-BS Manual

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PROFESSIONAL MEDICAL PRODUCTS
MISURATORE DI PRESSIONE GIMA BLUETOOTH
GIMA BLUETOOTH B.P.MONITOR
TENSIOMÈTRE BLUETOOTH GIMA
MEDIDOR DE PRESIÓN DEL BLUETOOTH DEL GIMA
32916 / LS808-BS
Guangdong Transtek Medical Electronics Co., Ltd.
Zone A, No.105, Dongli Road,
Torch Development District,
Zhongshan, 528437, Guangdong, China
Made in China
MDSS - Medical Device Safety Service GmbH
Schiffgraben 41, 30175 Hannover, Germany
Gima S.p.A.
Via Marconi, 1 - 20060 Gessate (MI) Italy
gima@gimaitaly.com - export@gimaitaly.com
www.gimaitaly.com
0123

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Summary of Contents for Gima LS808-BS

  • Page 1 PROFESSIONAL MEDICAL PRODUCTS MISURATORE DI PRESSIONE GIMA BLUETOOTH GIMA BLUETOOTH B.P.MONITOR TENSIOMÈTRE BLUETOOTH GIMA MEDIDOR DE PRESIÓN DEL BLUETOOTH DEL GIMA 0123 32916 / LS808-BS Guangdong Transtek Medical Electronics Co., Ltd. Zone A, No.105, Dongli Road, Torch Development District,...

  • Page 2: Table Of Contents

    ENGLISH Table of Contents INTRODUCTION ........................31 General Description ........................31 Indications for Use ........................31 Contraindications ........................31 Measurement Principle ......................31 Safety Information ........................31 LCD Display Signal........................35 Monitor Components .........................36 List .............................36 BEFORE YOU START ......................37 Power Supply and Charge Power .....................37 Setting the Time, Date and Unit....................38 Pair-up the Blood Pressure Monitor with Your Device ...............40 Tie the Cuff ..........................42 MEASUREMENT ........................43...

  • Page 3: Introduction

    The design pro- vides you with two years of reliable service. Readings taken by the LS808-BS are equivalent to those obtained by a trained observer using the cuff and stethoscope auscultation method.
  • Page 4 ENGLISH Follow instructions Temperature limit Type BF applied part for use Symbol for WEEE disposal For indoor use only “RECYCLE” The Green Dot is the license symbol of a European network of industry-funded systems for recycling the packaging materials of consumer goods. CAUTION •...
  • Page 5 ENGLISH • Please check that operation of the device does not result in prolonged impairment of patient blood circulation. • When measurement, please avoid compression or restriction of the connection tubing. • The device cannot be used with HF surgical equipment at the same time. •...
  • Page 6 • If you have any problems with this device, such as setting up, maintaining or using, please contact the SERVICE PERSONNEL of Gima. Don’t open or repair the device by yourself in the event of malfunctions. The device must only be serviced, repaired and opened by individuals at authorized sales/service centers.

  • Page 7: Lcd Display Signal

    ENGLISH LCD Display Signal SYMBOL DESCRIPTION EXPLANATION Systolic High blood pressure Blood Pressure Diastolic Low blood pressure Blood Pressure Pulse display Pulse in beats per minute Low Battery Low battery and please charge the power. + Lo Measurement Unit of the blood pressure (1kPa=7.5mmHg) Measurement Unit of the blood pressure mmHg...

  • Page 8: Monitor Components

    1. Blood Pressure Monitor 2. AC Adaptor (LS808-BS) (Model: BLJ06L060100P-V) 3. User Manual 4. Cuff (22cm-42cm ) (Type BF Applied Part) (Please use Gima authorized cuff. The size of the actual cuff please refer to the label on the attached cuff.)

  • Page 9: Before You Start

    ENGLISH BEFORE YOU START Power Supply and Charge Power 1. The battery of LS808-BS is built-in rechargeable li-polymer battery, the battery current is 1000 mAh. 2. Please use the AC adaptor to charge the battery, just like the following picture:...

  • Page 10: Setting The Time, Date And Unit

    ENGLISH • Do not clean the blood pressure monitor when it is being charged. Always unplug the charger first before cleaning the blood pressure monitor. • Do not dispose of your blood pressure monitor in a fire. The battery could explode causing injury or death.
  • Page 11 ENGLISH 3. Press “User 1” button again to confirm [YEAR]. Then the numeral representing [MONTH] blinks. 4. Repeat step 2 and 3 to confirm [MONTH ] and [DAY ]. 5. Repeat step 2 and 3 to confirm [HOUR] and [MINUTE].

  • Page 12: Pair-Up The Blood Pressure Monitor With Your Device

    ENGLISH 6. Repeat step 2 and 3 to confirm unit. 7. After confirming the [UNIT], the LCD will display “dONE” then the monitor will shut off. Pair-up the Blood Pressure Monitor with Your Device 1. Turn on Bluetooth and the app. Make sure both are ON when pair-up is proceeding. 2.
  • Page 13 ENGLISH 4. Then please select the user ID you want to connect with your smartphone on the app to contin- ute the pair-up. If SUCCEED, symbol If FAIL , symbol will be shown on the LCD. will be shown on the LCD. 4.The monitor will shut off after Pair-up process is complete.

  • Page 14: Tie The Cuff

    • Interference may occur in the vicinity of equipment marked with the following symbol . And LS808-BS may interfering vicinity electrical equipment. • Sensitive people, including pregnant women pre-eclamptic and those who implanted medical electronic instruments, should avoid using the unit whenever possible.

  • Page 15: Measurement

    ENGLISH MEASUREMENT Start Measurement When the monitor is off, press User 1 button to turn on the monitor and it will finish the whole measurement, and then save the measure data . (Take User 1 for example.) (Note: Select the same user on your app and BPM to take the measurement, or the measurement data won’t be transmitted to the app.) 1.

  • Page 16: Data Management

    ENGLISH If the data transmission succeeds, If the data transmission fails, the Bluetooth symbol will appear the Bluetooth symbol will not appear then the device will turn off. then the device will turn off. Tips: A. Maximum 60 records are both for user 1 and user 2. DATA MANAGEMENT Recall the Records 1.
  • Page 17 ENGLISH 2. Press the “Query” button again to get the record you want. The date and time of the record will be shown alternately. The current No. The corresponding date The corresponding time is No 1. is January 2nd. is 8:00. CAUTION The most recent record (1) is shown first.

  • Page 18: Delete The Records

    ENGLISH 4. If there is no record, press “Query” button, the below display will be shown. CAUTION The most recent record (1) is shown first. Each new measurement is assigned to the first (1) record. All other records are pushed back one digit (e.g., 2 becomes 3, and so on), and the last record (60) is dropped from the list.

  • Page 19: Information For User

    ENGLISH INFORMATION FOR USER Tips for Measurement Measurements may be inaccurate if taken in the following circumstances. Within 1 hour Immediate measurement after dinner or drinking after tea, coffee, smoking When talking or moving Within 20 minutes your fingers after taking a bath In a very cold When you want to environment...

  • Page 20: Maintenance

    ENGLISH Maintenance To obtain the best performance, please follow instructions below. Put in a dry place Avoid immersing it in the water. and avoid the sunshine Clean it with a dry cloth in case. Avoid dusty environment and unstable Avoid intense shaking and collisions. temperature surrounding Use the slightly damp cloth to remove the dirt.

  • Page 21: About Blood Pressure

    ENGLISH ABOUT BLOOD PRESSURE What are systolic pressure and diastolic pressure? When ventricles contract and pump blood out of the heart, the blood pressure reach- es its maximum value in the cycle, which is called systolic pressure. When the ven- tricles relax, the blood pressure reaches its minimum value in the cycle, which is called diastolic pressure.

  • Page 22: Why Does My Blood Pressure Fluctuate Throughout The Day

    ENGLISH CAUTION The appearance of the IHB icon indicates that a pulse irregularity consistent with an irregular heartbeat was detected during measurement. Usually this is NOT a cause for concern. However, if the symbol appears often, we recommend you seek medical advice. Please note that the device does not replace a cardiac examination, but serves to detect pulse irregularities at an early stage.

  • Page 23: Troubleshooting

    ENGLISH TROUBLESHOOTING This section includes a list of error messages and frequently asked questions for prob- lems you may encounter with your blood pressure monitor. If the products not operating as you think it should, check here before arranging for servicing. PROBLEM SYMPTOM CHECK THIS...

  • Page 24: Specifications

    ENGLISH SPECIFICATIONS Power supply 3.7V 1000mAH Built-in rechargeable li-polymer battery, 6V 1A AC Adaptor Display mode Digital LCD display V.A.= 86.1mm(L) x24mm(W) Measurement mode Oscillographic testing mode Measurement range Rated cuff pressure: 0mmHg~299mmHg(0kPa ~ 39.9kPa) Measurement pressure: SYS: 60mmHg~230mmHg (8.0kPa~30.7kPa) DIA: 40mmHg~130mmHg (5.3kPa~17.3kPa) Pulse value: (40-199)beat/minute Accuracy...

  • Page 25: Athorized Component

    ENGLISH ATHORIZED COMPONENT 1. Please use the Gima authorized adaptor Adaptor Type: BLJ06L060100P-V Output: 100-240V 50-60Hz,0.2Amax Input: 1000mA Contact Information Manufactured by: Guangdong Transtek Medical Electronics Co., Ltd. Company: Guangdong Transtek Medical Electronics Co., Ltd. Address: Zone A, No.105 ,Dongli Road, Torch Development District, Zhongshan,528437,Guang-...

  • Page 26: Complied Standards List

    ENGLISH COMPLIED STANDARDS LIST Risk management EN ISO 14971:2012 / ISO 14971:2007 Medical devices - Applica- tion of risk management to medical devices Labeling EN ISO 15223-1:2016 / ISO 15223-1:2016 Medical devices. Symbols to be used with medical device labels, labelling and information to be supplied.

  • Page 27: Emc Guidance

    Warning: Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the equip- ment LS808-BS , including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.
  • Page 28 ENGLISH Table 2 Guidance and manufacturer’s declaration – electromagnetic Immunity Immunity Test IEC 60601-1-2 Compliance level Test level Electrostatic ±8 kV contact ±8 kV contact discharge (ESD) ±2 kV, ±4kV, ±8 kV, ±15 kV air ±2 kV, ±4kV, ±8 kV, ±15 kV air IEC 61000-4-2 Electrical fast ±2 kV for power supply lines...
  • Page 29 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.

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