Omron M3500 Bedienungsanleitung

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Machinery and equipment such as 21 visceral function test instrument

Non-invasive blood pressure module

Blood pressure measurement module M3500

Be sure to refer to the instruction manual

Creation or revision date

** March 1, 2012 (third edition)

* October 17, 2011 (second edition)

Approval and notiﬁcation, etc.

Brand Name

Blood pressure measurement module M3500

Attached document management code

22200BZX00227000_A_01

Approval Number

22200BZX00227000

Approval date

March 2010

General designation for

36551000

Non-invasive blood pressure module

warning

not listed

Contraindications ban

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(1)

Combination medical equipment (not to be used in place of the below)

Flammable anesthetic gas and the high concentration used in the oxygen atmosphere

[explosion, or there is a danger of ﬁre. ]

- In combination with high-pressure oxygen therapy device [explosion, or there is a danger of

ﬁre. ]

Magnetic resonance imaging apparatus There is a risk of causing accidents caused by

combination [induced electromotive force of the (MRI devices). ]

how to use

- That you do not use If the exterior of the cuff there is corruption.

[There is a risk of rupture during the measurement. ]

Shape and structure and principles, etc.

This unit is a blood pressure measuring module designed to measure the non-invasive blood

pressure (NIBP).

External view and each part of the name

Dimensions and mass

Dimensions: 40 (W) ×60 (H) ×105 (D) mm

Weight: about 220g ± 10%

Electrical Ratings

Electrical rating

12V specification 6V Specifications

Rated voltage DC12V DC6V

Power input 680mA 1,300mA

Inrush current 2A below 3A below

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(2)

Four.

Five.

Classiﬁcation of equipment

** Blitz degree of protection against by the mounting portion of the classiﬁcation: arm

band B-shaped mounting portion

usage environment

Temperature: 0 ~ 50 ℃

Humidity: 30 to 85% (non-condensing)

Standard accessory

The following as a standard accessory comes with one point.

** · IEC adult cuff or GS cuff M

** - Adult Kafuhosu (3.5m)

Silicon tube chassis joint / nut

Optional Accessories

Apart from the standard accessories, to this device can be combined with the product has the

following.

· IEC adult oversized cuff · IEC children cuff (9cm, 7cm)

** - Adult cuff (S, M, L, XL)

** · GS cuff (SS, S, L, XL)

And neonatal / infant Disupokafu (No.10, No.11, No.12, No.13)

** - Adult Kafuhosu (1.5m)

And neonatal for Kafuhosu (3.5m)

Air ﬁlter

Operating and operation principle

In the oscillometric method blood pressure measurement oscillometric method, it captured the

pulsation of the artery as the vibration of the cuff pressure, to measure the blood pressure. It

pressed enough pressure to the cuff wound to the upper arm and the blood ﬂow will stop, but the

beat of the artery is present, also vibration cuff internal pressure in response to it. Then, when

gradually reduce the cuff pressure vibration of the cuff pressure is gradually increases,

eventually it reached a peak,

In addition go and vibration by reducing the cuff pressure would be Ikima smaller. The

relationship between the increase and decrease of the vibration of the cuff pressure and cuff

pressure in this series of processes and memory and calculation, to determine the blood pressure

value.

Systolic blood pressure cuff internal pressure of typically, when vibration is rapidly increased,

And the lowest blood pressure cuff internal pressure at the time of the decrease rapidly.

In addition, the cuff pressure when the vibration of the peak is the mean arterial pressure.

Intended use, efﬁcacy or effect

This device, by the non-invasive measurement of arterial blood pressure is used to display the

systolic and diastolic blood pressure.

Item speciﬁcations, etc.

Error of blood pressure measurement by the clinical performance test

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Four.

Five.

(1)

(2)

(3)

(Four)

Error average of the auscultation: ± 5mmHg within the standard deviation: 8mmHg within

Cuff pressure display of error: within ± 3mmHg

Quick exhaust

Adult (children and infants):

The time required in order to rapidly exhaust to 15mmHg from 260mmHg: 10 seconds or less

newborn:

The time required in order to rapidly exhaust to 5mmHg from 150mmHg: less than 5 seconds

Cuff pressure display of stability:

10,000 change in the display value of the cycle cuff pressure after the simulated measurement of:

3mmHg below

** Maximum pressure

Adults: 300mmHg

Newborn: 150mmHg

Method of operation or use method and the like

Since that is operated by the operation buttons of the assembled multi-item monitoring, operation

button of the device is not used.

Method of operation is as follows for the operation check.

Method of operation

Wrap the cuff on the arm of the subject.

Power is supplied to the unit, and then to the blood pressure measurement possible state.

Measurement start and press the stop switch, to start the measurement.

After the measurement, remove the cuff from the subject.

PRECAUTIONS

In the case of the following, or please carefully apply to the following of the subject.

- The direction from the doctor has been pointed out the bleeding tendency or hypercoagulable

state (can cause faulty circulation by point-like bleeding or blood clots after tightening the arm in

the cuff.)

And natural rubber (latex) the subject of allergy: the cuff being attached genus or option on this

device may have the use of natural rubber. Please check whether there is an abnormality in the

site where the hose touches. Natural rubber, itching, redness, nettle rash, swelling, fever,

breathing difﬁculties, asthma-like symptoms, decrease in blood pressure, may cause rare allergic

symptoms such as shock or be. In such a case that caused the symptoms, please immediately

subjected to a mid-sealed appropriate measures to use. The presence or absence of natural rubber

use mosquito off the document attached Please check

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Important Precautions

In the periphery of, the apparatus and the person to be measured, the power supply, such as

mobile phones and small radio (PHS terminal that is allowed to use is excluded) because it is not

concerned with the cut again.

· Unmeasurable and when you have doubts about the measurements, please make sure the person

to be measured ﬁrst.

· Please use devices also document attached to the cuff to be used from read them carefully to

measure. In this package document it does not has indicated up to those notes.

Specifying the consumables, please do not use other than the optional accessories.

- For each person to be measured, or please make sure that the alarm settings are appropriate

before use.

[Non-invasive blood pressure measurement]

Such as, infusion and transfusion, please do not wound the cuff to a limb that has been vein

secured.

- Please do not wound the cuff to the limb with an artiﬁcial dialysis shunt.

· Please measure with an appropriate cuff size. Doing so may result of measurement error.

- From time to time, to check the measurement site, please change the measurement site if there

is an abnormality. Or causing the peripheral circulatory failure, rash caused by sweat, and cause

internal bleeding.

- Please note the bending of the Kafuhosu. Peripheral dysfunction due to the fact that not exhaust

may occur.

• If the following can not be unmeasurable or measured correctly.

- Peripheral circulatory failure and signiﬁcant hypotension, the case of hypothermia

• If a high frequency of arrhythmia

• If there is a weak continuous vibration from the heart massage in and outside

- Convulsions, tremors, involuntary movements, if there is a body movement such as

trembling

• If the cuff mounting portion is different from the height of the heart (10cm is different

when the blood pressure value height might maximum 7 ~ 8mmHg different)

• If you talk or move during the measurement

• If you attach the cuff from the top of the thick clothing

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If you have pressure on the arms, it was raised tucked clothing

• If you are using a heart-lung machine (because there is no beat)

· In the case of pseudo-hypertension

Interaction

- The periphery of the person at the time of deﬁbrillator use please away from the device and the

cords that are connected to the subject and the subject. We received a blitz by energization

energy of the deﬁbrillator.

Or - at the time of deﬁbrillator use is energized as much as possible away from the electrodes

attached to the chest, please instead of attaching the electrodes to the appropriate position.

When the deﬁbrillator paddles to energize while touching the electrode, it will cause burns to the

site.

And electric knife during use and after use be sure to check the operation of the machine. It may

indicate the measurements wrong by the noise of the electric knife.

- Of the electric knife if attachment of the return electrode is inappropriate, it can cause burns in

the subject mounting portion. Please carefully read the instruction manual of the electric knife

for more information.

Microwave therapy equipment equipment that generates the noise, such as you might not be able

to if measured correctly in the vicinity.

- Such as the commercially available personal computer to the external I / O connector, please do

not direct connection with the equipment that does not meet the medical safety standards

(IEC60601-1 or IEC safety standards). Please connect Ri by the company designation of ways to

connect. If an unspeciﬁed connection you may want to shock due to the leakage current.

Other Notes

And non-invasive blood pressure measurement is done by squeezing the arm.

Or feel a strong pain in some people, it may be transient Madaragami by subcutaneous

hemorrhage. This plaque is Suga disappears over time, the possibility of a person to be measured

to be made in care We tell you that the "Madaragami is there is a Rukoto", you may need to

refrain from the measurement.

Storage and storage method and duration of use, etc.

Storage condition

(1) Please keep to the environment, such as the following.

** Temperature: -20 ~ 70 ℃(standard accessories, optional accessories are excluded)

Humidity: 30% to 95% (non-condensing)

Life

Six years after installation (self by our data authentication)

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However, this is a case that has been used in the recommended environment, such as regular

maintenance and inspection, there may be a difference through the use situation arises.

Matters relating to the maintenance and inspection

[User, and skilled in the art by the maintenance and inspection matters]

Notes

- For a while when you re-use the equipment that was not used, make sure that you always the

equipment before use to operate successfully and safely.

- Body, accessories, connector, in the opening portion of the housing, with blowing liquid Ketari,

pouring, please do not spill. Otherwise, you may get an electric shock.

- Disposable products in order to prevent infection, do not re-use. (There is also a thing that can

be re-used only the same person to be measured.)

- Do not use paint thinner, solvents such as benzene to clean. These solvents will damage the

surface of the plastic.

Inspection before use

- In appearance, there is no deformation such as by dropping, Ri was dirty, Please check not wet.

Cuff, please make sure that you are using the speciﬁed ones.

Inspection after the power is turned on

- Smoke or out, or there is no strange smell, please check whether the abnormal noise is not

heard.

[Maintenance and inspection matters by the trader]

Notes

- Clean, because there is a risk of electric shock, please be performed by far the communication

connector.

* Please insert the communication connector After cleaning from the well dried.

• The unit, autoclave, can not be used gas sterilization (formaldehyde gas, EOG, high

concentration ozone, etc.). The equipment will cause a deterioration.

Inspection before use

· That the cords are not damaged (exposure of the core, disconnection, etc.),

Please make sure that there is no slack in the cords of connection.

- Please check do not place heavy objects on top of the code.

Inspection after the power is turned on

• Press the each switch, make sure that the function is activated.

• Each measurement is performed normally, please make sure the measurement error is within

the reference value.

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Four.Care

• When the body is dirty, to include an anti-venom for the alcohol that was neutral detergent or

diluted and diluted, drop the dirt by wiping with a soft cloth that has been squeezed tightly.

However, please do not wipe the electrical connector portion.

Packing

Packed in a single unit

Manufacturing distributors and manufacturers of name and address, etc.

Name or name

Omron Healthcare Co., Ltd.

First-class medical equipment manufacturing and sales

Address, etc.

* Yubinbango617-0002 Kyoto Muko Terato cho Kyunotsubo 53 address

phone number

Customer Support Center 0120-103-203 (24 hours a day / toll-free)

Foreign manufacturers:. OMRON (Dalian) Co., Ltd. OMRON (DALIAN) CO, LTD (People's

Republic of China)

Sales Source: Omron Colin Co., Ltd. Yubinbango112-0002

Tokyo, Bunkyo-ku Koishikawa chome 12 address No. 14 Nippon Life Insurance Koishikawa

Building

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