iHerz iTop Manual Download Page 6

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deviation. Please consult your physician about the result.

* Don’t kink the connection tube during use, otherwise, the cuff pressure may continu

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ously increase which can prevent blood flow and result in harmful injury to the PATIENT.

* When using this device, please pay attention to the following situation which may inter

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rupt blood flow and influence blood circulation of the patient, thus cause harmful injury 

to the patient: connection tubing kinking too frequent and consecutive multiple measure-

ments; the application of the cuff and its pressurization on any arm where intravascular 

access or therapy, or an arterio-venous (A-V) shunt, is present; inflating the cuff on the 

side of a mastectomy.

* Warning: Do not apply the cuff over a wound;otherwise it can cause further injury.

*Do not inflate the cuff on the same limb which other monitoring ME equipment is applied 

around simultaneously, because this could cause temporary loss of function of those 

simultaneously-used monitoring ME equipment.

*On the rare occasion of a fault causing the cuff to remain fully inflated during measure

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ment, open the cuff immediately. Prolonged high pressure (cuff pressure 

>

 300mmHg 

or constant pressure > 15mmHg for more than 3 minutes) applied to the arm may lead 

to an ecchymosis.

*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.

* The ACCOMPANYING DOCUMENT shall disclose that the SPHYGMOMANOMETER

was clinically investigated according to the requirements of ISO 81060-2:2013.

* To verify the calibration of the AUTOMATED SPHYGMOMANOMETER, please contact 

the manufacturer.

* This device is contraindicated for any female who may be suspected of, or is pregnant. 

Besides providing inaccurate readings, the effects of this device on the fetus are unknown.

* Too frequent and consecutive measurements could cause disturbances in blood

circulation and injuries.

* This unit is not suitable for continuous monitoring during medical emergencies or op

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erations. Otherwise, the patient’s arm and fingers will become anaesthetic, swollen and 

even purple due to a lack of blood.

* When not in use, store the device in a dry room and protect it against extreme moisture, 

heat, lint, dust and direct sunlight. Never place any heavy objects on the storage case.

* This device may be used only for the purpose described in this booklet. The manufac

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turer cannot be held liable for damage caused by incorrect application.

*This  device  comprises  sensitive  components  and  must  be  treated  with  caution. 

 

Observe the storage and operating conditions described in this booklet.

* The equipment is not AP/APG equipment and not suitable for use in the presence of a

flammable anesthetic mixture with air of with oxygen or nitrous oxide.

* Warning: No servicing/maintenance while the ME equipment is in use.

* The patient is an intended operator.

* The patient can measure data and change batteries under normal circumstances and

maintain the device and its accessories according to the user manual.

* To avoid measurement errors, please avoid the condition of strong electromagnetic

field radiated interference signal or electrical fast transient/burst signal.

* The blood pressure monitor and the cuff are suitable for use within the patient environ

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ment. If you are allergic to polyester, nylon or plastic, please don’t use this device.

* During use, the patient will be in contact with the cuff. The materials of the cuff have 

Summary of Contents for iTop

Page 1: ...automatic BLOOD PRESSURE MONITOR model iTop model iTop...

Page 2: ...blood pressure and pulse cor rectly For all questions concerning the device please contact your local distributor or TM iHerz service centre in your country ATTENTION This blood pressure monitor is d...

Page 3: ...physical or mental activity environment etc Day Night Fluctuations of the Blood Pressure An increase of blood pressure increases the burden onto the heart affects blood vessels making their walls thic...

Page 4: ...140 mmHg is more crucial than diastolic pressure Even with blood pressure being normal people run the bigger risk of hypertension development with advancing age ATTENTION If you have normal results of...

Page 5: ...re eclampsia premature ventricular beats atrial fibrillation peripheral arterial disease and patients undergoing intravascular therapy or arterio venous shunt or people who received a mastectomy Pleas...

Page 6: ...fy the calibration of the AUTOMATED SPHYGMOMANOMETER please contact the manufacturer This device is contraindicated for any female who may be suspected of or is pregnant Besides providing inaccurate r...

Page 7: ...oth to clean the whole unit before and after use Don t use any abrasive or volatile cleaners The device doesn t need to be calibrated within two years of reliable service If you have any problems with...

Page 8: ...tteries 1 5 V AAA user s manual warranty card kit box Description of the Blood Pressure Monitor 1 AIR CONNECTOR PLUG 2 LCD DISPLAY 3 MEM BUTTON 4 SET BUTTON 5 START STOP BUTTON 6 CUFF 7 AIR HOSE 8 BAT...

Page 9: ...n indicator Motion may result in an inaccurate measurement mmHg Measurement Unit of the blood pres sure Low battery Batteries are low and need to be replaced Irregular heartbeat Blood pressure monitor...

Page 10: ...ep Repeat steps 2 and 3 to set the MONTH and DAY 4 Repeat steps 2 and 3 to confirm the time format 12H and 24h 5 Repeat steps 2 and 3 to set the HOUR and MINUTE 6 Repeat steps 2 and 3 to set the UNIT...

Page 11: ...tery mark over the main artery on the inside of your arm Note Locate the main artery by pressing with 2 fingers approximately 2 cm above the bend of your elbow on the inside of your left arm Identify...

Page 12: ...is off please press the MEM to show the average value of the latest three records If the records are less than three groups it will display the latest record first 2 Press the MEM or SET to get the re...

Page 13: ...will not light up Batteries are exhausted Replace with new batteries Batteries are inserted incorrectly Insert the batteries correctly Low batteries Display is dim or show Batteries are low Replace wi...

Page 14: ...ke sure that the device is working properly before use If you are suffering from a heartbeat disorder arrhythmia evaluation of measurement results of the device can be given only after consultation wi...

Page 15: ...ime to time For this reason verification of the indication of statistical pressure periodically once a year and after technical maintenance and repair is recommended More information can be obtained f...

Page 16: ...ange of 93 non condens ing at a water vapour pressure up to 50hPa Measurement perimeter of the upper arm About 22cm 32cm or 22cm 42cm Net Weight Approx 182g Excluding the dry cells External dimensions...

Page 17: ...quipment Part 1 11 General requirements for basic safety and essential performance Collateral standard Requirements for medical electrical equipment and medical electrical systems used in the home hea...

Page 18: ...magnetic fields near the unit This may result in incorrect operation of the unit 3 Caution This unit has been thoroughly tested and inspected to assure proper performance and operation 4 Caution This...

Page 19: ...ality should be that of a typical commercial or hospital environment Voltage dips short interrup tions and voltage variations on power supply input lines IEC 61000 4 11 0 UT 0 5 cycle At 0 45 90 135 1...

Page 20: ...tion is affected by absorption and reflection from structures objects and people a Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile...

Page 21: ...es NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people Table 5 Recommended separation distan...

Page 22: ...test distance is permitted by IEC 61000 4 3 a For some services only the uplink frequencies are included b The carrier shall be modulated using a 50 duty cycle square wave signal c As an alternative t...

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