Bedienungsanleitung Rossmax SA310 (Seite 1 von 2) (Englisch)

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SpO2

Measuring range 35% – 100% (the resolution is 1%)

Accuracy 70% – 100% (No Motion. ±2%, Motion. ±3%, Low Perfusion. ±2%)

Pulse Rate

Measuring range 30 – 250 bpm (the resolution is 1 bpm)

Accuracy 30 – 250 ± 3 digits

Probe Type

Probe model Rossmax PA100, PB100, PC100, PD100(Single Use), PF100

Extension cord Rossmax PE100

Battery AA * 4 (Alkaline)

Battery Life Continually for 15 hours with 4 alkaline batteries

AC Adaptor Model: HK-X205-A06, HK-XW05-A06, (W=1,2,3,4), HKKS-13116, HKKS-13117

Input: AC100-240V, 50/60Hz, 0.2A max; Output: DC 6V, 0.8A

Environmental conditions

Operation Condition Temperature: 5°C – 40°C (41°F – 104°F), Relative Humidity:15% – 95%(non

condensing), Atmospheric pressure: 700hPa ~ 1013hPa

Storage /Transport

Condition Temperature: -20°C – 70°C (-4°F – 158°F), Relative Humidity:15% – 95%(non

condensing), Atmospheric pressure: 700hPa ~ 1013hPa

Note: The condition of -20°C or 70°C back to use should stand for 3 hours at

room temperature.

Dimension Size: 14.5(L) x 7.25(W) x 2.25cm(H)

Weight About 150g (without the batteries)

Standard IEC/EN60601-1, IEC/EN60601-1-2, IEC/EN60601-1-11, ISO80601-2-61

Symbol Descriptors

Manufacturer

Serial number

EU representative

Type BF (Body Floating

IP22: Protected against foreign objects and moisture

CE Mark

Warning: the symbol on this product means that it’s an electronic product

and following the European directive 2012/19/EU the electronic products

have to be dispose on your local recycling centre for safe treatment.

Contains of natural rubber latex

Symptoms Check points Corrections

SpO2 or Pulse rate

cannot displayed

The icon “- -“ shows on the

screen try again.

ACT PPG

This icon means probe

connect failure.

Be sure ”Rossmax” probe is

connected to the device

correctly.

ACT PPG

This icon means probe

dysfunction Replace with new probe.

try again

SpO2 or Pulse rate are

not displayed stably

Finger is shaking or body is moving Keep body steady

try again

No display when the

bottom is pressed

Batteries run down Replace with new batteries

Batteries inserted incorrectly Re-insert batteries

The display disappears

suddenly gets no signal Normal

Low battery Replace with new batteries

Note: If the unit does not work, return it to your dealer. Under no circumstance should you

disassemble and repair the unit by yourself.

Note: After clearing data, the icon will show 0 data.

Caution: The deleted data could not be restored.

Warning

Cleaning

Memories mode- Save Cycle

Memories mode- Clear Data

Specication

Troubleshooting

Audio Signals

• This device is not intended for use by people (including children) with restricted physical, sensory or

mental skills or a lack of experience and/or a lack of knowledge, unless they are supervised by a per-

son who has responsibility for their safety or they receive instructions from this person on how to

use the device. Children should be supervised around the device to ensure they do not play with it.

• This device only for spot-checking, but not medical result evaluation.

• This device is designed to determine the percentage of arterial oxygen saturation of functional

hemoglobin. Factors that may degrade pulse oximeter performance or aﬀect the accuracy of the

measurement include the following:

- Do not apply the pulse oximeter on the same arm as a blood pressure cuﬀ, arterial catheter or

infusion line (s)

- Excessive light, such as sunlight or direct home lighting.

- Not steady at the site of application (e.g. term-bling)

- Moisture in the device

- Improperly applied device

- Finger is too large or too small to ﬁt into the device

- Poor pulse quality

- Venous pulsations

- Anemia or low hemoglobin concentrations

- Cardio green and other intravascular dyes

- Carboxyhemoglobin

- Methemoglobin

- Dysfunctional hemoglobin

- Artiﬁcial nail or ﬁngernail polish

- On ﬁngers with anatomical changes, oedemas, scars or burns.

- The conditional of probe. Use only the Rossmax approved pulse oximeter sensor, cable and

accessories. Use of other sensors, cable and accessories can result in inaccurate readings.

• Using the device for long periods may cause pain for people with circulatory disorders. Reposition

the device (probe) at least once every 4 hours to allow the patient’s skin to breath and to check

patient’s condition regularly.

• Do not use the device near ﬂammable or explosive gas mixtures.

• Do not use the device during an MRI or CT scan, be used no closer than 30 cm (12 inches) to any part

of the [ME EQUIPMENT or ME SYSTEM], including cables speciﬁed by the manufacturer.

• The device will be aﬀected by electromagnetic interference during operation.

• A warning that other cables and accessories may negatively aﬀect EMC performance.

• The device may not work when circulation is reduced. Warm or rub the ﬁnger, or re-position the

device.

• This device is a precision electronic instrument and must be repaired by qualiﬁed technical

professionals. Field repair of the device is not possible. Do not attempt to open the case or repair

the electronics. Opening the case may damage the device and void the warranty.

• Do not overextend the device’s spring.

• A functional tester cannot be used to access the accuracy of a pulse oximeter monitor.

• Do not self-diagonse or self-medicate on the basis of the measurements without consulting your

doctor. In particular, do not start taking any new medication or change the type and/or dosage of

any existing medication without prior approval.

• Do not look directly inside the housing during the measurement. The red light and the invisible

infra-red light in the probe are harmful to your eyes.

• Please be aware that user with susceptible skin.

• As with all medical equipment, carefully route patient cabling to reduce the possibility of patient

entanglement or strangulation.

1. Please clean the surface of the device before using. Wipe the device with medical alcohol (70%

isopropyl alcohol) ﬁrst, and then let it dry in air or clean it by dry clean fabric.

2. Using the medical alcohol to clean the product after use, prevent from cross infection for next

time use.

3. The best storage environment of the device is -20°C ~ 70°C ambient temperature and not higher

than 95% relative humidity.

Note: 1. Do not sterilize, autoclave or immerse this device in liquid. Do not pour or spray any liquids

onto the device.

2. Do not use caustic or abrasive cleaning agents, or any cleaning agent containing ammonium

chloride or isopropyl alcohol.

Optional of memory interval: 60 / 30 / 10 seconds

• Press the button and / button to highlight “Memory” option, and then press the

button to select the option.

• Entry “Memory Mode”, press the / button to highlight “Save Cycle” option, and then press

the button to select the option.

• Entry “Save Cycle”, press the / button to highlight option, and then press the button

to select the option.

• Press the / button to change the value; press the button to save the desired value.

• Press the / button and the button to select “Back/Exit” to return.

• Press the button and / button to highlight “Clear Data” option, and then press the

button to select the option.

• Entry “Clear Data”, press the / button to highlight “Sure” option, and then press the

button to select the option.

• Press the / button and the button to select “Back/Exit” to return.

No. Name LCD Display Sound Control

1 Power on

V0.00 à

Beep for 2 seconds Press button

Software

version àstart measure

2Pulse

search The icon X X

Max./ Min

SpO2 and

Pulse rate

warning

Show or in red icon.

limits.

Beep-beep sounded

repeatedly Default

Mute for temporary, will

Beep-beep sounded

after two minutes. mode

mode

Bar Chart

• Entry “Data History”, press the / button to highlight “Bar Chart” option for viewing statistics

of SpO2, and then press the button to select the option.

• Entry “SpO2 Memory Data”, press the button to go back to the monitoring screen.

Memory Transfer to ROSSMAX App

• Entry into “Data History”, press the / button to highlight “Memory Transfer” option, and

then press the button to start data transmission for a few seconds.

Note: Before entering the data history mode, the icon should collect more than 1 data.

4Probe

failure

alarm

The icon shows

on the screen Beep-beep sounded

repeatedly X

Probe

connect

failure

alarm

The icon shows

on the screen Beep-beep sounded

repeatedly x

6Low

battery

alarm

The icon shows

on the screen

Beep-beep sounded

repeatedly for 1 minute x

7Automatic XBeep-beep sounded After pulse is unde-

tectable for around

1 minute.

8Unable

measure

Blood saturation

& pulse rate

appears “ - - “

Beep-beep sounded

repeatedly. x

9 AC Power icon X X

Model: SA310

www.rossmax.com

Handheld Pulse Oximeter

60/30/10

seconds

Electromagnetic Compatibility Information

1. This device needs to be installed and put into service in accordance with the information provided in the user

manual.

2. WARNING: Portable RF communications equipment (including peripherals such as antenna cables and external

by the manufacturer. Otherwise, degradation of the performance of this device could result.

Manufacturer’s declaration-electromagnetic immunity

of the SA310 should assure that is used in such and environment.

Immunity test IEC 60601 test level Compliance level Electromagnetic environment-guidance

Conducted RF

IEC 61000-4-6

3 Vrms:

0,15 MHz – 80 MHz

6 Vrms: in ISM and

amateur radio bands

between

0,15 MHz and 80 MHz

80 % AM at 1 kHz

3 Vrms:

0,15 MHz – 80 MHz

6 Vrms: in ISM and

amateur radio bands

between

0,15 MHz and 80 MHz

80 % AM at 1 kHz

Portable and mobile RF communications

equipment should be used no closer to any

part of the SA310 including cables, than the

recommended separation distance calculated

from the equation applicable to the frequency

of the transmitter.

Recommended separation distance:

d = 1,2 √P, d = 1,2 √P 80MHz to 800 MHz, d = 2,3

√P 800MHz to 2,7 GHz

Where P is the maximum output power rating

of the transmitter in watts (W) according to the

transmitter manufacturer and d is the recom-

mended separation distance in metres (m).

Interference may occur in the vicinity of equip-

ment marked with the following symbol:

Radiated RF

IEC 61000-4-3

10 V/m

80 MHz – 2,7 GHz

80 % AM at 1 kHz

10 V/m

80 MHz – 2,7 GHz

80 % AM at 1 kHz

NOTE1: At 80 MHz and 800 MHz, the higher frequency range applies.

More information on EMC compliance of the device may be obtained from Rossmax using the contacts shown

in this manual.

IN0SA311000000030

RI_IB_SA310_EN_2Yr_

TP_ver1838

Warranty Card

This instrument is covered by a 2 year guarantee from the date of purchase, batteries

and accessories are not included. The guarantee is valid only on presentation of the

guarantee card completed by the dealer conﬁrming date of purchase or the receipt.

Opening or altering the instrument invalidates the guarantee. The guarantee does

not cover damage, accidents or non-compliance with the instruction manual. Please

contact your local seller/dealer or www.rossmax.com.

Customer Name: __________________________________________________

Address: _________________________________________________________

Telephone: _______________________________________________________

E-mail address: ____________________________________________________

Product Information:

Date of purchase: __________________________________________________

Store where purchased:

__________________________________________________________________

Rossmax InnoTek Corp.

12F., No. 189, Kang Chien Rd., Taipei, 114, Taiwan.

CMC Medical Devices & Drugs S.L.

C/ Horacio Lengo N° 18, CP 29006, Málaga, Spain

Rossmax SA310 Anleitung

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