The following symbol indicates that the device is MR-unsafe:
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- Hortense Norman
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3 The following symbol indicates that the device is MR-unsafe: MR Unsafe Do not use this equipment In the MRI scan room Patient must follow the doctor s instructions and should not perform a self-assessment or follow selftreatment following the measurement result. Self-diagnosis and treatment following measurement results are dangerous. The device should not be used to check for illness, as first aid or for continuous monitoring. This device cannot be used while transporting a patient or in surgical care. It must be used at home or in fixed locations only. Please press the on/off button if the wrist feels uncomfortable or the air is inflating abnormally without stopping. This device should not be used for a child under 12 or by the people who can t express their agreement. When used on young people (12-18 years old), they should accompanied by an Adult. It may cause an accident or lead to problems. Do not use the unit for any purpose other than measuring blood pressure. It may cause an accident or lead to problems. Please do not use a mobile phone near the device. Please do not use the device near a magnetic field. The device must not be used while moving. Do not use the equipment in outdoor areas or shower rooms. Do not disassemble, repair or remodel the main unit of the blood pressure monitor or wrist strap. The unit may function erroneously. REQUESTS FROM MANUFACTURER Make sure there is no kink in the connection tubing before measuring to prevent any injury to the patient. Do not measure a patient more than 3 times continuously. A period of at least 5 minutes should be left between any two measurements; otherwise it may cause extravasation of the blood. Do not measure your blood pressure more than 6 times each day. Do not apply the strap over a wound, as this can cause further injury. Do not measure on the wrist which is on the side of a mastectomy, otherwise it may cause injury. Observe the air pressure value from the LCD display. The pressure must not exceed 280 mmhg while measuring. If it does, press the on/off button to stop it. Do not force or bend the wrist strap or air tubing. Do not strike or drop the main unit. Always use the accessories specified in the manual; the use of other parts not approved by the manufacturer may cause faults or injury. For service information and parts list, please contact the dealer.
4 Diastolic blood pressure Reference Material: Journal of Hypertension 1999, Vol 17 No.2 Grade 3 hypertension (severe) Grade 2 hypertension (moderate) Grade 1 hypertension (mild) High-normal Normal Optimal Systolic blood pressure Typical fluctuation within a day (Measured every five minutes) Systolic Blood Pressure Diastolic Sleep Time
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8 Measuring Method Indication Measuring Range: SPECIFICATIONS Oscillometric Measurement Digital LCD display Pressure:(30~280)mmHg Pulse:(40~199)Beat/min Accuracy: Static Pressure: +3mmHg Pulse: +5% Memory: Power supply: 90 Memories 2x1.5V Batteries(LR03 or AAA) Use alkaline batteries. Lasts for over 200 measurements.
9 Operating conditions: Storage conditions: Dimensions: Weight: Classification +5 C~+40 C. 15%RH~93%RH Atmospheric pressure: 70kPa~106kPa -20 C~+55 C. 0%RH~93%RH Atmospheric pressure:50kpa~106kpa Approximately 62(W)x78(H)x31(D)mm Approximately 130g, excluding batteries Type BF Wrist circumference cm * Specifications may be changed without notice in the event of improvements being made. 1. Type of protection against electric shock: INTERNALLY POWERED EQUIPMENT. 2. Degree or protection against electric shock: TYPE BF APPLIED PART. 3. Mode of operation: CONTINUOUS OPERATION. 4. Equipment not suitable for use in the presence of AP&APG category equipment. WARNING The system might not meet its performance specifications if stored or used outside the temperature and humidity as mentioned below: Operating conditions: +5 C~+40 C. 15%RH~93%RH 70kPa~106kPa Storage conditions: -20 C~+55 C. 0%RH~93%RH TROUBLESHOOTING If you have any problems using the unit, please check the following points first. ERROR DISPLAY POSSIBLE CAUSE ACTION Nothing is displayed When you push the POWER button or Battery icon flashes. E1: Cannot increase pressure E3: Inflation pressure too high E2E4: Shaking while measuring No batteries installed Battery worn out Battery polarities wrong Check the wrist strap for air leakage Pressure greater than 299mmHg Hand or body is shaking Insert batteries Replace with new batteries Insert batteries correctly Replace wrist strap with a new one Re-measure or return to dealer for pressure re-calibration Stay still in proper position and remeasure Battery icon on Battery power low Replace battery and measure again
10 Systolic or diastolic pressure too high 1. Wrist strap is held lower than your heart 2. Wrist strap not attached properly 3. You moved or spoke during measurement Stay still in proper position and remeasure Appendix 1 Guidance and Manufacturer Declaration Tables Guidance and manufacturer s declaration - electromagnetic emissions The Model PG-800A33 Series Electronic Blood Pressure Monitor is intended for use in the electromagnetic environment specified below. The customer or the user of the Model PG- 800A33 Series Electronic Blood Pressure Monitor should assure that it is used in such an environment. Systolic or diastolic pressure too low 1. Wrist strap is held higher than your heart 2. You moved or spoke during measurement Stay still in proper position and remeasure Emissions Compliance Electromagnetic environment-guidance RF emissions CISPR11 Group 1 The Model PG-800A33 Series Electronic Blood Pressure Monitor uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. RF emissions CISPR 11 Harmonic emissions IEC Class B N. A. The Model PG-800A33 Series Electronic Blood Pressure Monitor is used in the home and is powered by a 3VDC power source. Voltage fluctuations/ flicker emissions IEC N. A.
11 Guidance and manufacturer s declaration - electromagnetic immunity The Model PG-800A33 Series Electronic Blood Pressure Monitor is intended for use in the electromagnetic environment specified below. The customer or the user of the Model PG- 800A33 Series Electronic Blood Pressure Monitor should assure that it is used in such an environment. Immunity test Electrostatic discharge (ESD)IEC P o w e r frequency (50/60 Hz) magnetic field IEC IEC test level ±8 kv contact ±2 kv, ±4 kv, ±8 kv, ±15KV air Compliance level ±8 kv contact ±2 kv, ±4 kv, ±8 kv, ±15 KV air Electromagnetic environment- guidance Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%. 30A/m,50/60Hz 30A/m,50/60Hz Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment. NOTE UT is the AC mains voltage prior to application of the test level Guidance and manufacturer s declaration - electromagnetic immunity The Model PG-800A33 Series Electronic Blood Pressure Monitor is intended for use in the electromagnetic environment specified below. The customer or the user of the Model PG- 800A33 Series Electronic Blood Pressure Monitor should assure that it is used in such an environment. Immunity test Conducted RF IEC IEC test level 3 Vrms 150kHz to 80 MHz 6 Vrms 150 khz to 80 MHZ outside ISM bands Compliance level Electromagnetic environment - guidance N/A Portable and mobile RF communications equipment should be used no closer to any part of the Model PG-800A33 Series Electronic Blood Pressure Monitor, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance
12 Radiated RF IEC V/m 80 MHz to 2.7 GHz 10V/m 80MHz to 800MHz 800MHz to 2.7GHz where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in metres(m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, a should be less than the compliance level in each frequency rangeb. Interference may occur in the vicinity of equipment marked with the following symbol:
13 Recommended separation distances between portable and mobile RF communications equipment and the Model PG-800A33 Series Electronic Blood Pressure Monitor. The Model PG-800A33 Series Electronic Blood Pressure Monitor is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Model PG-800A33 Series Electronic Blood Pressure Monitor can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Model PG-800A33 Series Electronic Blood Pressure Monitor as recommended below, according to the maximum output power of the communications equipment. Rated maximum output of transmitter/w Separation distance according to frequency of transmitter/m 150 khz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2,7 GHz 0,01 0,12 0,12 0,23 0,1 0,38 0,38 0,73 1 1,2 1,2 2,3 10 3,8 3,8 7, For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
14 Manufacturer: Shenzhen Pango Electronic Co., Ltd. Tel: Fax: Main Site: No.25 1st Industry Zone, Fenghuang Road, Xikeng Village, Henggang Town, Longgang District, Shenzhen, Guangdong China Additional site: 2-4 Floor, No.5 Shanzhuang Rd., Xikeng Village, Henggang Town, Longgang District, Shenzhen City, Guangdong Province, China Authorized representative: Tel: Fax: Address: 1 Four Seasons Terrace West Drayton, Middlesex London, UB7 9GG United Kingdom. Date: Rev:A/1
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