Brugsanvisning Medisana PM 180 Pulsoximeter

Brugsanvisning

DE/GB 79493 PM 180 10-Mar-2025 Ver. 1.2

GB Instruction manual

Pulse Oximeter PM 180

Device and controls

Explanation of symbols

This instruction manual belongs to this device. The instruc-

tion manual includes important information on the initial

start-up and handling. Read this instruction manual com-

pletely. Failure to follow these instructions may result in seri-

ous injury or damage to the device.

WARNING

These warnings must be followed to prevent possible injury

to the user.

CAUTION

These instructions must be followed to prevent possible

injury to the device.

NOTE

These instructions provide you with useful additional infor-

mation regarding installation or operation.

IP22 IP22

The device is protected against splashing water. Water

splashed against the enclosure from any direction shall have

no harmful e󰀨ects.

Disposal only according to the “WEEE” Waste Electrical and

Electronic Equipment EC Directive.

Recycling symbols/codes: These are used to provide infor-

mation about the material and its proper use and recycling.

2797

Complies with the European Medical Device Regulation

(EU) 2017/745.

CAUTION /

注意！查阅随机文件

Type BF applied part /

BF型应用设备

Read the instructions for use /

请阅读说明书

Device in protection class 2 /

二类设备

Manufacturer / 制造商

Keep dry / 保持干燥 / 怕雨

WEEE

S

N

Serial number

Permissible storage and transport

temperature and humidity

Storage/Transport

Operation

Permissible operating temperature

and humidity

Medical device

Distributor

Date of manufacture

Do not use outdoors

(indoor use only)

Single patient multiple use

PA

2020F213-44

中国GCC血压计计量证号

REF

Reference number

LOT

Batch number

I

ON

OFF

Dispose of packaging in an

environmentally friendly manner

70°C 95%

-25°C

Storage/Transport

10% 700hPa

1060hPa

10°C

40°C

95%

700hPa

1060hPa

Operating

10%

Importer

Catalogue Number Batch code

#

Model Number

CAUTION /

注意！查阅随机文件

Type BF applied part /

BF型应用设备

Read the instructions for use /

请阅读说明书

Device in protection class 2 /

二类设备

Manufacturer / 制造商

Keep dry / 保持干燥 / 怕雨

WEEE

S

N

Serial number

Permissible storage and transport

temperature and humidity

Storage/Transport

Operation

Permissible operating temperature

and humidity

Medical device

Distributor

Date of manufacture

Do not use outdoors

(indoor use only)

Single patient multiple use

PA

2020F213-44

中国GCC血压计计量证号

REF

Reference number

LOT

Batch number

I

ON

OFF

Dispose of packaging in an

environmentally friendly manner

70°C 95%

-25°C

Storage/Transport

10% 700hPa

1060hPa

10°C

40°C

95%

700hPa

1060hPa

Operating

10%

Importer

Serial Number

Device classication: type

BF applied part

CAUTION /

注意！查阅随机文件

Type BF applied part /

BF型应用设备

Read the instructions for use /

请阅读说明书

Device in protection class 2 /

二类设备

Manufacturer / 制造商

Keep dry / 保持干燥 / 怕雨

WEEE

S

N

Serial number

Permissible storage and transport

temperature and humidity

Storage/Transport

Operation

Permissible operating temperature

and humidity

Medical device

Distributor

Date of manufacture

Do not use outdoors

(indoor use only)

Single patient multiple use

PA

2020F213-44

中国GCC血压计计量证号

REF

Reference number

LOT

Batch number

I

ON

OFF

Dispose of packaging in an

environmentally friendly manner

70°C 95%

-25°C

Storage/Transport

10% 700hPa

1060hPa

10°C

40°C

95%

700hPa

1060hPa

Operating

10%

Importer

Medical Device No Alarm

EC REP

Authorized rep-

resentative in the

European Com-

munity / European

Union

Humidity range

Keep away from

direct sunlight

Ambient pressure limita-

tion

UDI

Unique Device

Identier

Temperature range

Importer Keep dry

CN

Country of

Manufacturer

Date of manufacture

Manufacturer

Direct voltage / Direct

current

CAUTION /

注意！查阅随机文件

Type BF applied part /

BF型应用设备

Read the instructions for use /

请阅读说明书

Device in protection class 2 /

二类设备

Manufacturer / 制造商

Keep dry / 保持干燥 / 怕雨

WEEE

S

N

Serial number

Permissible storage and transport

temperature and humidity

Storage/Transport

Operation

Permissible operating temperature

and humidity

Medical device

Distributor

Date of manufacture

Do not use outdoors

(indoor use only)

Single patient multiple use

PA

2020F213-44

中国GCC血压计计量证号

REF

Reference number

LOT

Batch number

I

ON

OFF

Dispose of packaging in an

environmentally friendly manner

70°C 95%

-25°C

Storage/Transport

10% 700hPa

1060hPa

10°C

40°C

95%

700hPa

1060hPa

Operating

10%

Importer

medisana GmbH,

Carl-Schurz-Str. 2, 41460 NEUSS,

GERMANY

AViTA Corporation

9F., No. 78, Sec. 1, Kwang Fu Rd.,

San Chung Dist., New Taipei City 24158,

Taiwan, China.

EC REP

MDSS GmbH

Schi󰀨graben 41, 30175 Hannover, GERMANY

GB IMPORTANT INFORMATION!

KEEP IN A SAFE PLACE!

Please read this instruction manual care-

fully, in particular the safety instruc-

tions, before using the device. Keep the

instruction manual in a safe place for

later reference. If you pass the device on

to a third party, this instruction manual

must remain with the device.

WARNINGS

• The device is not to be used for commercial use or medical purposes.

• Do not use the oximeter in an explosive atmosphere to avoid explosion hazard.

• Do not use the oximeter when applied part temperature is over 41ºC (105.8ºF).

• The oximeter has to measure the pulse properly to obtain accurate SpO

2

values. Blood ow

restrictors (e.g., blood pressure cu󰀨s) may hinder pulse measurements. Remove any objects

that may hinder the performance of the oximeter.

• The medisana PM 180 is not an SpO

2

alarm device. Please do not use the PM 180 in any

alarm-required situation.

• Exposure to strong external light while taking a measurement may result in inaccurate val-

ues. Shield the sensors from bright lights. Strong electromagnetic elds may also a󰀨ect

measurements.

• Nail polish and pressed-on nails may interfere with measurements.

• Intravenous dyes (such as methylene blue, indigo carmine, and indocyanine green) can

cause inaccurate measurements.

• Seek professional advice if the measured values are irregular. The PM 180 is designed to

measure numeric values related to user health condition, but not for diagnosis or interpreta-

tion of health condition.

• Irregular heartbeats or movements of the patient can post an irregular signal.

• Do not rely only on a pulse oximeter to assess health condition or oxygen level.

• Only a health care provider can diagnose a medical condition such as hypoxia (low oxygen levels)

.

• Changes or trends in measurements may be more meaningful than one single measurement

.

• Pulse oximeters are not intended for continuous real-time monitoring and as such do not

have alarms or alerts.

• Consider accuracy limitations when using the pulse oximeter. For example, a pulse oximeter

saturation of 90% may represent an arterial blood saturation of 87-93%. Use pulse oximeter

measurements as an estimate of blood oxygen saturation.

• Pulse oximeters are less accurate when oxygen saturations are less than 80%, at lower

perfusion, at low signal or high noise.

• If monitoring at home, pay attention to other signs of symptoms of low oxygen levels, such as:

― Bluish colouring in the face, lips, or nails.

― Shortness of breath, di󰀩culty of breathing, or a cough that is getting worse.

― Restlessness and discomfort.

― Chest pain or tightness.

― Racing pulse rate.

― Be aware that some patients with low oxygen levels may not show any or all of these

symptoms.

• Be aware that multiple factors can a󰀨ect the accuracy of a pulse oximeter measurement,

such as incorrect sensor placement, poor circulation, skin pigmentation, skin thickness, skin

temperature, current tobacco use.

• If you are concerned about the pulse oximeter reading, or your symptoms are serious or

getting worse, contact a health care provider.

• Device should only be used over intact skin.

• The Pulse Oximeter is MRI unsafe. Do not use the oximeter in an MRI or CT environment.

• The oximeter is intended as an adjunct in subject assessment. It must be used in conjunction

with other methods to assess clinical signals and symptoms.

• When replacing the battery of the device, a user should not to touch the battery contact or

battery and the patient simultaneously.

• Please do not leave the device to a child and always keep the battery cover attached to avoid

swallowing by a child.

• If any serious incident that has occurred in relation to the device should be reported to the

manufacturer and the competent authority of the Member State in which the user is estab-

lished.

CAUTION

• The PM 180 pulse oximeter is not an apnea monitor.

• Signicant levels of dysfunctional hemoglobin such as carbonxyhemoglobin or methemo-

globin may a󰀨ect the accuracy of the measurement.

• Cardio green and intravascular dyes may a󰀨ect the accuracy of the PM 180.

• The performance of the oximeter might be a󰀨ected by the presence of a debrillator.

• The oximeter may not work on all subjects. If you are unable to achieve stable measurement

values, please discontinue use.

• The oximeter has a motion tolerant algorithm to minimize the inuence of motion artifacts.

However, the oximeter may be still inuenced by motion. Please minimize any motion by the

patient as much as possible.

• All the materials of the oximeter in contact with a patient or a user have passed all tests

according to EN ISO 10993 Biological Evaluation of Medical Devices.

It shall be no toxicity

harm to children, pregnant or nursing women.

• The PM 180 can be operated by either a patient or trained personnel. Consult health care

professionals before use.

• The oximeter might not work on cold extremities due to poor circulation. Please warm or rub

the nger, or reposition the device to improve it.

• Check the applied site of a patient frequently to evaluate body circulation and skin sensitiv-

ity. The recommended maximum applied time at a single spot is 30 minutes. Misapplication

of the oximeter on applied site with excessive pressure for prolonged periods can introduce

pressure injury.

BATTERY SAFETY INFORMATION

• Do not disassemble batteries!

• Clean the battery and device contacts if necessary before putting in the batteries!

• Remove discharged batteries from the device immediately!

• Increased risk of leakage, avoid contact with skin, eyes and mucous membranes! If battery

acid comes in contact with any of this parts, rinse the a󰀨ected area with copious amounts of

fresh water and seek medical attention immediately!

• If a battery has been swallowed seek medical attention immediately!

• Replace all of the batteries simultaneously!

• Only replace with batteries of the same type, never use di󰀨erent types of

batteries together or used batteries with new ones!

• Insert the batteries correctly, observing the polarity!

• Keep the battery compartment well sealed!

• Remove the batteries from the device if it is not going to be used for an extended period!

• Keep batteries out of children’s reach!

• Do not attempt to recharge these batteries! There is a danger of explosion!

• Do not short circuit! There is a danger of explosion!

• Do not throw into a re! There is a danger of explosion!

• Keep unused batteries in their packaging away from metal objects in order to prevent short

circuiting!

• Do not throw used batteries into the household refuse; put them in a hazardous waste con-

tainer or take them to a battery collection point, at the shop where they were purchased!

Principle of Operation

The medisana Pulse Oximeter PM 180 is a non-invasive spot checking device that uses the

principles of spectrophotometry by emitting red and infrared light through a pulsating capillary

bed, typically a ngertip. A sensor detects the light that passes through the tissues, measuring

the intensity of both wavelengths. (See Fig. 5.)

Based on the di󰀨erences in absorption between oxygenated and deoxygenated hemoglobin

(HbO), the device calculates the oxygen saturation (SpO

2

), which is then displayed together

with the pulse rate (PR).

This multi-use device is for prescription only, it is not provided sterile, and it should be used

during no-motion conditions to avoid inaccurate measurements. It is not intended for life-sup-

porting or life-sustaining purposes, implantation, or continuous monitoring. It does not contain

any drugs or biological products.

The device consists of a sensor, electronic circuits, a two-color OLED screen, and a plastic

enclosure, all powered by a battery. It is software-driven and does not include alarms.

Pulse Indicator:

The Pulse Indicator displays a loading bar 6 when a pulse is detected. Then the bar will

continue showing the pulse signal, but it does not indicate the signal strength, nor will it a󰀨ect

the strength of signal.

Pulse Waveform Display:

The display provides the pulse waveform 7 to detect the real-time sensor signal. The relative

pulsation rate of the input signal can be observed.

Scope of Delivery

• 1 medisana Pulse Oximeter PM 180

• 1 User Manual

• 1 Alkaline battery, size AAA (Micro), type LR03

• 1 Lanyard

• 1 Bag

Product Structure

1 Display (OLED, 2 colors)

5

Display of the oxygen saturation in percentage

6

PR bpm – Pulse rate in beats per minute

7

The pulse Indicator shows the signal being detected by the oximeter.

8

/ Battery level indicator (left: battery full, right: battery low)

2 Rotate Button

3 Opening for nger (on rear side of the device)

4 Battery compartment

Notes:

• All items are non-sterile.

• If any item is missing or if you notice any transport damage when unpacking, please contact

your dealer immediately.

The packaging can be reused or

recycled. Please dispose prop-

erly of any packaging material no

longer required.

WARNING

Please ensure that the poly-

thene packing is kept away

from the reach of children!

Risk of su󰀨ocation!

Intended use

• The medisana Pulse Oximeter PM 180 is intended for measuring functional oxygen satura-

tion of arterial hemoglobin (SpO

2

) and pulse rate (PR) for adults as non-invasive spot check-

ing in professional caring environment. It is designed for ngers between 0.8 cm and 2.3 cm

(0.3 inches to 0.9 inches), see Fig. 6, and for patients during no-motion condition.

Contraindications:

• Presence of an ongoing need for measurement of pH, PaCO

2

, total hemoglobin, and abnor-

mal hemoglobin may be a relative contraindication to pulse oximeters.

• A pulse oximeter cannot distinguish between oxygen and carbon monoxide, so that both

will be shown as the total saturation level of oxygen. Carbon monoxide molecules, even in a

small amount, can attach to the patient’s hemoglobin replacing oxygen molecules.

• Irregular heartbeats or movements of the patient can post irregular signals.

• A high level of methaemoglobin would cause a pulse oximeter to have a reading of around

85% regardless of the actual oxygen saturation level. The higher percentage of methaemo-

globin can be genetic or caused by exposure to certain chemicals and medications.

Using the PM 180 for the First Time

The PM 180 is delivered with a protective plastic foil that is attached to the front panel. Please

remove the plastic membrane to allow the OLED display to show its best performance. The

PM 180 is calibrated in the factory before delivery, there is no need to (re-)calibrate it during

its life-time.

Battery Replacement

Before starting any measurement, please make sure the battery power is su󰀩cient and the

setting is correct. When replacing the battery, please make sure the PM 180 is switched o󰀨.

Then open the battery cover and install a new battery (see Fig. 4).

CAUTION

• Please use an alkaline battery to ensure the best performance of the

device.

• Please dispose of the battery according the the proper procedure.

• It is recommended not to use rechargeable, unqualied or batteries of

a wrong specication, which may damage the device or cause circuit

shortcut.

Operation

• Open up the oximeter and put one of your ngers into the opening.

• Please make sure that your nger is oriented face up and touches the bottom (Inner Base)

of the opening before releasing the clamp (see Fig. 5).

• The device will turn on automatically after the nger has been inserted.

• After detecting the pulse signal, the oximeter shows the SpO

2

and pulse rate on the display.

The readings will be updated based on the signal received with each pulse.

• During the operation, each time you press the key 2 the screen rotates so that the user can

see the display in the desired view angle.

• If the nger is not detected or removed, the oximeter will show “Finger Out”. As no motion is

being detected, the device will turn o󰀨 automatically after about 8 seconds.

• After use, follow the cleaning instruction to clean the device thoroughly.

What does the measured result mean?

The oxygen saturation (SpO

2

) of the blood is a term referring to the concentration of oxygen

attached to human hemoglobin. The normal value lies between 95 and 100% SpO

2

. A too low

value may be an indication for existing diseases like e.g. a cardiac defect, problems of the

circulatory system, asthma or specic diseases of the lung. Circumstances such as a too fast

and too deep breathing, however, can cause a higher value than appropriate for the health

state of the patient, which harbours the risk of false conclusions. In no way is the value meas-

ured with this device suitable to make or conrm a diagnosis – contact your doctor under all

circumstances to get a correct diagnosis.

Troubleshooting

Problem Possible causes Solution

The oximeter won’t

turn on.

The battery is dead. Replace with a new battery.

The battery is installed

incorrectly.

Check that the polarity of the battery

is correct.

Finger might be trembling

or placed incorrectly.

Keep the nger steady or align the

nger inward at vertical-middle of

the device.

Display lockup or

blank. If the device is

on a nger, changes

do not appear at

wave form or pulse

indicator.

Problem with the measur-

ing function.

The measurement values might not

be reliable; discontinue using the

device.

Electromagnetic interfer-

ence (EMI).

Remove the surrounding electronic

devices away. e. g. MRI, CT at

hospital, or microwave at home

environment.

Finger might be trembling

or placed incorrectly.

Keep the nger steady or align the

nger inward at vertical-middle of

the device.

No reading of SpO

2

or pulse rate and

shows dash-line.

Low nger pulse quality. Please try the following:

• Reposition the nger

• Warm the nger by rubbing.

• Select another nger.

SpO

2

or pulse rate

warning/indicator

appears

The patient’s condition is

abnormal.

Provide immediate medical attention

to this patient.

Low battery “

“

appears on display.

The battery power is low. Replace with a new battery.

NOTE

If you have followed the actions recommended above but the problem

keeps unresolved, please call your local distributor for assistance.

Clean and Disinfection

• For home use device disinfection, use 75% alcohol (available in the pharmacy) with damp

cloth for cleaning and disinfection. The device can be cleaned this way up to 1000 times.

Clean the body and the nger groove thoroughly.

• Never use abrasive cleaning agents, thinners or benzene for cleaning. Do not scratch the

surface of the lens or the display. Do not expose the oximeter to extreme temperatures,

humidity, direct sunlight, or shock.

• Do not immerse the pulse oximeter into water, as the liquid can penetrate and damage the

device.

• Never place any heavy objects on the device.

Maintenance and Storage

• Remove the battery inside the battery compartment if the oximeter will not be operated for

more than one month.

• It is best to preserve the device in a place that fullls the storage conditions listed in Section

“Technical Specications”.

• The commercially available bench top functional testers and patient simulators may only be

suitable to validate the pulse rate, but may not be able to verify the proper oximetry of this

pulse oximeter. Please consult your distributor or the manufacturer for advise on a proper

model and the usage of functional testers and patients simulator for this oximeter.

• Furthermore, after a long term operation, the light sensor within the device may degrade with

time. The testers and simulators may be useful for verifying that the pulse oximeter is work-

ing normally. A functional tester cannot be used to assess the accuracy of pulse oximeter

device.

• During the warranty period, if it is obvious that the device has been misused or has been

opened or tampered with the components within the housing by non-authorized service per-

sonnel, the warranty will be invalidated and a charge for repair will be assessed.

• Do not spray, pour, or spill any liquid on the oximeter, accessories, switches or openings.

• Do not use caustic or abrasive cleaning agents on the oximeter.

• This is a precision medical instrument and must be repaired only by personnel qualied by

the manufacturer.

• Please follow local regulations and recycling instructions for disposal or recycling of the

device and its components.

Technical Specications

Name and model: medisana Pulse Oximeter PM 180 (model SP64)

Power supply: Battery 1.5 V

, size AAA (Micro), type LR03

Display: Two colors OLED display

Automatic switch on/o󰀨: Whenever user inserts a nger, the device turns on auto-

matically. The device turns o󰀨 automatically when the nger is

removed from it.

Input key:

key 2 to rotate the display

Measurement Method: Wavelengths

SpO

2

Range and Resolu-

tion:

Range: 0% to 100%; resolution: 1%

SpO

2

Accuracy: ± 2% within 70% to 100%,

less than 70%: unspecied

Pulse Rate Range and

Resolution:

Range: 30 to 250 bpm; resolution: 1 bpm

Pulse Rate Accuracy: ±2 bpm or ±2%, whichever is greater

Water-resistance: Against water splash (IP22 Approved)

Lifetime: 3 years

Ambient Temperature: Operation: 5 ºC … 40 ºC (41 ºF … 104 ºF);

Storage: −30 ºC … 70 ºC (22 ºF … 158 ºF)

Atmospheric Pressure: Operation & storage: 700 hPa … 1060 hPa

Humidity: Operation & storage: 10% … 90%, non-condensing

Dimensions (L × W × H): approx. 68 × 37.8 × 27.7 mm

Weight: approx. 25 g without battery

Article number: 79493

EAN number: 4015588 79493 3

Disposal — Waste Electrical and Electronic Equipment (WEEE)

This product is subject to European Directive 2012/19/EU on waste electrical

and electronic equipment and is marked accordingly. Never dispose of electronic

devices with household waste. Please seek out information about the local regu-

lations with regard to the correct disposal of electrical and electronic products.

Correct disposal helps to protect the environment and human health. All users

are obliged to hand in all electrical or electronic devices, regardless of whether or

not they contain toxic substances, at a municipal or commercial collection point

so that they can be disposed of in an environmentally acceptable manner. Consult your local

authority or your supplier for information about disposal.

Warranty and repair terms

Your statutory warranty rights are not restricted by our guarantee below. Please contact your

dealer or the service centre in case of a claim under the warranty. If you have to return the unit,

please enclose a copy of your receipt and state what the defect is.

The following warranty terms apply:

1. The warranty period for medisana products is 3 years from date of purchase. In case of

a warranty claim, the date of purchase has to be proven by means of the sales receipt or

invoice.

2. Defects in material or workmanship will be removed free of charge within the warranty

period.

3. Repairs under warranty do not extend the warranty period either for the unit or for the

replacement parts.

4. The following is excluded under the warranty:

a. All damage which has arisen due to improper treatment, e.g. non-observance of the

user instructions.

b. All damage which is due to repairs or tampering by the customer or unauthorised third

parties.

c. Damage which has arisen during transport from the manufacturer to the consumer or

during transport to the service centre.

d. Applied parts which are subject to normal wear and tear.

5. Liability for direct or indirect consequential losses caused by the unit are excluded even if

the damage to the unit is accepted as a warranty claim.

Information about service can be found here: https://www.medisana.com/servicepartners

In accordance with our policy of continual product improvement, we reserve the

right to make technical and visual changes without notice.

The complete instructions for use are available for download at

https://docs.medisana.com/79493

1

2

Fig. 2: Front View

Fig. 4:

Insert Battery

3 4

Fig. 1: Side View

Fig. 5: Insert Finger

Fig. 6: Position of Finger

Fig. 3: Display

5

6 7

8

2797

Bedømmelse

Mere om denne brugsanvisning

Vi forstår, at det er rart at have en papirbrugsanvisning til din Medisana PM 180 Pulsoximeter. Du kan altid downloade brugsanvisningen fra vores hjemmeside og selv printe den. Hvis du gerne vil have en original brugsanvisning, anbefaler vi, at du kontakter Medisana. De kan muligvis levere en original brugsanvisning. Leder du efter brugsanvisningen til din Medisana PM 180 Pulsoximeter på et andet sprog? Vælg dit foretrukne sprog på vores hjemmeside, og søg efter modelnummeret for at se, om vi har det tilgængeligt.

Specifikationer

Alle brugsanvisninger til Medisana Pulsoximeter
Flere brugsanvisninger til Pulsoximeter

Relaterede produkter

Brugsanvisning

Medisana PM 100 Connect Pulsoximeter

Brugsanvisning

Beurer PO 80 Pulsoximeter

Brugsanvisning

SilverCrest IAN 290989 Pulsoximeter

Brugsanvisning

SilverCrest IAN 297929 Pulsoximeter

Brugsanvisning

Beurer PO 30 Pulsoximeter

Brugsanvisning

SilverCrest IAN 322246 Pulsoximeter

Relaterede kategorier