RAUMEDIC NPS3 User manual

Instructions for Use –NPS3
Manufacturer: RAUMEDIC AG, Hermann-Staudinger-Str. 2, 95233 Helmbrechts, Germany
zwo-188 EN Rev. 11 / 2022-05-04
Page 1 of 10
Instructions for use of RAUMEDIC NPS3
(REF 091656-001)
1 Intended use
The NPS3 pressure display unit is an active medical product with internal power supply, which in
combination with other RAUMEDIC accessories, such as the ICP-TEMP-Cable (REF 094328-001), and
single-channel RAUMEDIC precision pressure catheters is used for short-time measurement of a
physiological pressure.
Warning: Limiting alarm values cannot be monitored with the NPS3 pressure display device!
The NPS3 can be used to display the pressure value of a pressure catheter prior to implantation. Three
pressure values per second are displayed after the particular pressure catheter has been implanted.
Fig. 1: Example of a typical measuring chain layout
2 Operational environment
The NPS3 is intended for use in clinical environments and doctor’s office to be operated by specialized
medical staff. The unit is used either stationary or mobile during transport in the hospital. Doctors,
intensive care nurses and medical technicians shall use the unit. The unit is not intended for use outside
of the hospitals, such as in helicopters or in ambulances. The NPS3 is not intended for use in domestic
settings.
3 Explanation of labels and symbols on the device
Battery low
Discharged battery
No sensor present
No sensor (pressure catheter) connected or cable interrupted or defective
Test 0 mmHg
Test button
0123
Device corresponds the essential requirements of Directive 93/42/EEC
This document is for information only

Instructions for Use –NPS3
Manufacturer: RAUMEDIC AG, Hermann-Staudinger-Str. 2, 95233 Helmbrechts, Germany
zwo-188 EN Rev. 11 / 2022-05-04
Page 2 of 10
Follow the instruction manual.
The patient connection is type CF and classified as defibrillation protected.
Please observe the disposal instructions. Do not put old units into the garbage.
4 Technical data
MDD 93/42 EEC classification: IIb
Rated voltage: 9 V DC
Rated power consumption: 40 mVA
battery operated
Class of protection: Type CF DIN EN 60601-1
IP degree of protection: IP 65
Sensor supply voltage: 5.00 V + 0.02 V
Display range: -199.9 mmHg to 199.9 mmHg
NPS3 zero-point error: + 1 mmHg (test button pressed)
Measuring error: + 1 mmHg plus error of the pressure measuring catheter
(+ 1 %)
NPS3 long-time stability: < 2 mmHg / 24 h
Type of battery: 9 V compound battery
Operating conditions:
Temperature: 10°C to 40°C
Relative humidity: 30-75% (non-condensing)
Air pressure: 620-1060 hPa (4000 m - 0 m)
Storage and transport conditions:
Temperature: 10°C to 40°C
Relative humidity: 30-75% (non-condensing)
Air pressure: 620-1060 hPa (4000 m - 0 m)
5 Tags and warning symbols on the packaging label
Keep away from sunlight
Store in a dry place
Attention! Observe accompanying instructions for use!
Date of manufacture
Observe disposal regulations. Do not throw used devices away in landfill waste.
Temperature limitation
This document is for information only

Instructions for Use –NPS3
Manufacturer: RAUMEDIC AG, Hermann-Staudinger-Str. 2, 95233 Helmbrechts, Germany
zwo-188 EN Rev. 11 / 2022-05-04
Page 3 of 10
Article number
Serial number
Device corresponds the essential requirements of Directive 93/42/EEC
6 Initial operation of the NPS3
The device (housing, foil keyboard, cable insulation, plug, label) must be visually inspected for intactness
every time before being started up. The device must not be used if defects are detected. It must be
returned to the manufacturer immediately.
Visual inspection
•Front film undamaged (watertight, button OK)?
•Name plate fitted and legible?
•Housing undamaged (no cracks or sharp edges)?
•Cable connection and Redel coupling visually free from damage?
•Housing screwed in three places?
•Are there any loose parts within the device (shake the device gently)?
•Is the device or accessories dirty?
NPS3 has no separate circuit closer. It is activated by plugging the ICP-TEMP-Cable (cf. chapter 14 –
accessories) into the NPS3.
Connection of measuring chain
•Connect the ICP-TEMP-Cable to the NPS3
The red “No sensor present” LED display has to be lit. If no LED is lit or the “Battery low” LED display
is on only, there is either no battery in the appliance or it has run too low. In either case, a new
battery has to be inserted (cf. chapter 7 on “Change of battery”).
•Connect the pressure catheter to the ICP-TEMP-Cable
The red “No sensor present” LED display will go out. At the same time, the numeric LCD will be
activated and will display the pressure value of the pressure catheter.
If the “No sensor present” LED display continues to be lit, the pressure catheter has not been
plugged in correctly or it is defective (due to broken cable, for example). In this case, the pressure
catheter has to be replaced. A defective ICP-TEMP cable may also be the reason for the fault, which
has to be replaced as well in this case.
Caution:
•For self-test of the zero point of the NPS3, a test shall have to be carried out prior to every use:
With the pressure catheter connected, press the ”Test 0 mmHg” button →0 mmHg must appear in
the display. Deviation of ±1 mmHg is acceptible. If a larger deviation is displayed, the NPS3 may not
be used anymore! Return the NPS3 to the manufacturer immediately!
Calibration of the zero point is not required for RAUMEDIC precision pressure catheters.
This document is for information only

Instructions for Use –NPS3
Manufacturer: RAUMEDIC AG, Hermann-Staudinger-Str. 2, 95233 Helmbrechts, Germany
zwo-188 EN Rev. 11 / 2022-05-04
Page 4 of 10
7 Change of battery
The battery has to be replaced either when the “Battery low” LED display lights up or when there is no
display at all due to a completely discharged battery.
Warning:
Remove discharged batteries as soon as possible! Batteries without lead proofing must not be used as
acid escaping from a discharged battery may cause the destruction of the unit. Discharged batteries must
not be disposed of in landfill. Correct disposal is provided via an old battery collection system.
Precaution:
The battery must not be changed when the pressure catheter has been implanted and connected. First of
all, disconnect the connecting cable from the pressure catheter!
The battery compartment can be accessed by undoing the screw on the rear side of the housing and by
removing the cover. Use a 9 V compound battery!
The battery compartment cover has to be carefully clipped into the hooks on the lower side of the unit first
for closing. Then screw down using a moderate force. Only in this manner can splash proofing be
ensured!
Any damage to the housing, to the display film and to the battery compartment cover will reduce the
protection against splash water. In case the housing and the membrane keyboard have been damaged,
the NPS3 may not be used anymore.
8 Cleaning
For cleaning, the NPS3 and the connecting cable are wiped with a cloth which previously has been
saturated in soap suds or 70 % isopropyl alcohol.
9 Disinfection
A short-time (maximum 5 min.) spray disinfection shall be permissible (recommended agent: Incidin
Liquid). Disinfectant must not be sprayed on to the contacts of the cable coupling! Subsequently, dry the
NPS3.
Warning:
•The use of potent solvent-containing agents shall not be permissible!
•The NPS3 must not be sterilised!
10 Servicing
The servicing activity is limited to a regular change of the battery.
There is nothing whatsoever that can be repaired by the operator. Defective or malfunctioning appliances
shall have to be returned to the manufacturer!
This document is for information only

Instructions for Use –NPS3
Manufacturer: RAUMEDIC AG, Hermann-Staudinger-Str. 2, 95233 Helmbrechts, Germany
zwo-188 EN Rev. 11 / 2022-05-04
Page 5 of 10
11 Warnings and precautions
Warnings:
•Do not make changes to the device!
•There is a risk of explosion in the presence of substances that are flammable in air, oxygen or
nitrogen oxide, such as anaesthetics, solvents, cleaning agents and endogenous gases!
•Do not open the NPS3 housing. The device cannot be repaired by the operator.
•Avoid connecting the patient to conductive parts, including electric earth/ground.
•Because alarm limits are not monitored, use in mobile emergency conveyances (e.g. ambulances) is
not permitted.
Precautions:
•If the device has been exposed to extreme transport and storage conditions, it must be adjusted to
the ambient temperature before it can be used.
•Only use approved RAUMEDIC accessories. Using other catheters and/or cables may impair or
disrupt the NPS3’s operation and endanger the health of the patient or user!
•Do not use NPS3 or accessories like catheters or cables, without checking beforehand that these
have not been damaged!
•Make sure that the ICP-TEMP-Cable is correctly connected to the NPS3 and pressure measurement
catheter and that the plug is correctly inserted in the designated socket. The pressure display may
not work if the connections are incorrect.
•In the event of intentional disconnection (e.g. for maintenance) of the pressure catheter and ICP-
TEMP-Cable, always disconnect the ICP-TEMP-Cable from the pressure catheter first.
•Do not pull on the catheter tube when separating the catheter from the ICP TEMP-Cable, but only on
the plug-in connector.
•Do not use the NPS3 and implanted intracranial pressure catheter at the same time as a high-
frequency surgical device or defibrillator.
•Do not insert the NPS3 into the magnetic field of an MRI!
•Do not place the NPS3 or ICP-TEMP-Cable in liquid!
•Do not autoclave or sterilise the NPS3! Do not autoclave the ICP-TEMP-Cable!
•Do not use solvents or detergents that may damage the plastic materials of the NPS3 or the ICP-
TEMP-Cable! Avoid any contact of corresponding liquids with the connectors of the NPS3 or ICP-
TEMP-Cable.
•Do not clean the inner surface of the NPS3 or ICP-TEMP-Cable connectors!
•Do not use the NPS3 if it has been damaged by a fall. Send it back to RAUMEDIC for checking.
•Do not use the NPS3 after the expiry date of its calibration. For the function of the NPS3, operating
or precision deviations may occur!
This document is for information only

Instructions for Use –NPS3
Manufacturer: RAUMEDIC AG, Hermann-Staudinger-Str. 2, 95233 Helmbrechts, Germany
zwo-188 EN Rev. 11 / 2022-05-04
Page 6 of 10
•This device has been tested and conforms to the standard IEC 60601-1-2. However, there is no
guarantee against electromagnetic disturbances in a particular situation. See Chapter 14
Electromagnetic compatibility for further information.
12 Safety information
•The NPS3 may only be employed by qualified medical personnel!
•Before every application an optical inspection of the NPS3 and the ICP-TEMP-Cable for possible
impurities (contamination) must be carried out. If contamination is detected, the devices must only be
used after cleaning and disinfection!
•The pressure catheter has not been fitted with protective measures to prevent the patient from being
burnt when high-frequency surgical equipment is used.
•Prior to using a high-frequency surgical device, the ICP-TEMP-Cable must be disconnected from the
pressure catheter.
•Observe the instruction manual for the pressure catheter being used! As the pressure catheters are
not generally protected against defibrillation, the pressure catheter and ICP-TEMP-Cable should be
disconnected prior to a planned defibrillation.
•However, if an unplanned defibrillation is carried out with the pressure catheter still connected, the
pressure catheter must then be either retested for correct operation as per section 6 or replaced.
•If the NPS3 comes into contact with liquids accidentally, it must be dried with a cloth prior to use.
13 Inspections, Safety and measurement related checks
13.1 General aspects
In addition, the national regulations and requirements derived from them must always be
observed.
The following checks must be carried out at least once a year for the safe and continuous
operation of the NPS3:
- Electrical safety test (leakage current)
- Check of the accuracy of the pressure measurement
The Medical Devices Operator Ordinance (German abbreviation: MPBetreibV) named below is a
German regulation and is therefore not binding for other countries.
As the manufacturer, we provide you with the option of having the necessary checks carried
out by RAUMEDIC.
These checks may only be carried out by appropriately qualified specialist personnel (suitable
training, knowledge and practical experience gained “on-the-job”).
This document is for information only

Instructions for Use –NPS3
Manufacturer: RAUMEDIC AG, Hermann-Staudinger-Str. 2, 95233 Helmbrechts, Germany
zwo-188 EN Rev. 11 / 2022-05-04
Page 7 of 10
13.2 Safety-related check
The operator must have safety checks performed for medical devices in accordance with
generally recognised technical regulations. He must allow such time limits for the safety
checks that corresponding defects that are to be expected on the basis of experience can be
detected in good time. The safety checks include measurement functions. The manufacturer
recommends a period of 12 months.
After each service action, a safety check must likewise be carried out.
13.3 Measurement-related check-up
The manufacturer recommends a period of 12 months to carry out the measurement check.
The measurement check must also be carried out if there are signs of non-adherence to the
specified thresholds (see chapter 4 Technical data) and if the metrological properties may have
been affected by interventions or in some other way.
The "Manual for instrumentation checks on medical products with a measurement function" (LMKM), Part
1 produced by the German National Metrology Institute (Revision: December 2016) is recommended for
orientation.
14 Accessories
Accessories of RAUMEDIC only may be used!
ICP-TEMP-Cable Art.-Nr. 094328-001
Catheter (Application part):
NEUROVENT-P Art. No. 092946-001
OMNIBAR E5F Art. No. 091204-001
To learn about other compatible catheters, ask the manufacturer.
This document is for information only

Instructions for Use –NPS3
Manufacturer: RAUMEDIC AG, Hermann-Staudinger-Str. 2, 95233 Helmbrechts, Germany
zwo-188 EN Rev. 11 / 2022-05-04
Page 8 of 10
15 Electromagnetic compatibility
The device fulfils the requirements of IEC 60601-1-2:2014. The device meets the general requirements
for basic safety and essential performance.
The electromagnetic characteristics of this equipment make it suitable for use in industrial areas,
hospitals and doctor’s office. If it is used in a residential environment this equipment might not offer
adequate protection to radio-frequency communication services. The user might need to take
mitigation measures, such as relocating or re-orienting the equipment.
15.1 Accuracy under the influence of electromagnetic interference phenomena
Essential performance under the influence of electromagnetic interference phenomena is defined as
follows:
Measuring point
Display parameter
Allowable variation
ICP
ICP
±2 mmHg
The catheter is placed in 0,9 % saline solution during the tests.
15.2 General information
Use of this equipment adjacent to or stacked with other equipment should be avoided because it could
result in improper operation. If such use is necessary, this equipment and the other equipment should
be observed to verify that they are operating normally.
Use of accessories other than those specified in chapter 14 could result in increased electromagnetic
emissions or decreased electromagnetic immunity of this equipment and result in improper operation.
Portable RF communications equipment (including peripherals such as antenna cables and external
antennas) should be used no closer than 30 cm (12 inches) to any part of the NPS3, including cables
specified by the manufacturer. Otherwise, degradation of the performance of this equipment could
result.
Avoid therapeutical microwave devices or similar units in the vicinity of the device.
In the event of a 15 kV electrostatic discharge (ESD), the display may briefly malfunction and be
unreadable.
Simultaneous operation with other devices connected to the patient may cause mutual influences which
may have an effect on the measuring results.
15.3 Electromagnetic emissions
The emissions characteristics of this equipment make it suitable for use in industrial areas, hospitals and
doctor’s office (CISPR 11 class B).
Measurement of emmisions
Immunity test level
Conducted emissionen
Not applicable
Radiated emissionen
CISPR 11, group 1, class B
Harmonic current emissions
Not applicable
Voltage changes, voltage fluctuations and
flicker emissions
Not applicable
This document is for information only

Instructions for Use –NPS3
Manufacturer: RAUMEDIC AG, Hermann-Staudinger-Str. 2, 95233 Helmbrechts, Germany
zwo-188 EN Rev. 11 / 2022-05-04
Page 9 of 10
15.4 Electromagnetic immunity
The NPS3 is intended for use in an electromagnetic environment as specified below. The operator or the
user of the NPS3 should ensure that it is operated in such an environment.
Measurement of Immunity
Immunity test level
Electrostatic discharge immunity
according IEC 61000-4-2
Contact: ±8 kV
Air: ±2 kV, ±4 kV, ±8 kV, ±15 kV
Radiated RF electromagnetic field
immunity according IEC 61000-4-3
80-2700 MHz; 1 kHz AM 80%; 3 V/m at 2 Hz
Immunity to proximity fields from RF
wireless communications equipment
according IEC 61000-4-3
385 MHz; Pulse modulation: 18 Hz; 27 V/m
450 MHz, Pulse modulation: 18 Hz; 28 V/m
710, 745, 780 MHz; Pulse modulation: 217 Hz; 9 V/m
810, 870, 930 MHz; Pulse modulation: 18 Hz; 28 V/m
1720, 1845, 1970 MHz; Pulse modulation: 217 Hz; 28 V/m
2450 MHz; Pulse modulation: 217 Hz; 28 V/m
5240, 5500, 5785 MHz; Pulse modulation: 217 Hz; 9 V/m
Electrical fast transient/burst immunity
according –a. c. mains according
IEC 61000-4-4
Not applikable
Electrical fast transient/burst immunity
according –I/O SIP/SOP ports
according IEC 61000-4-4
Not applikable
Surge immunity according
IEC 61000-4-5
Not applikable
Immunity to conducted disturbances
induced by RF fields –a. c. mains
according IEC 61000-4-6
Not applikable
Immunity to conducted disturbances
induced by RF fields –PATIENT ports
according IEC 61000-4-6
0,15 - 80 MHz; 3 Vrms, 80% AM at 2 Hz
In ISM bands; 6 Vrms, 80% AM at 2 Hz
Power frequency magnetic field
immunity according IEC 61000-4-8
30 A/m, 50 Hz and 60 Hz
Voltage dips, short interruptions
and voltage variations immunity nach
IEC 61000-4-11
Not applicable
16 Disposal
Defect products and/or products no longer used shall have to be returned to the manufacturer for
disposal.
Please observe the instructions for disposal; dispose in a professional manner:
This document is for information only

Instructions for Use –NPS3
Manufacturer: RAUMEDIC AG, Hermann-Staudinger-Str. 2, 95233 Helmbrechts, Germany
zwo-188 EN Rev. 11 / 2022-05-04
Page 10 of 10
17 Warranty and liability
The customer or user, respectively, shall be obligated to check the suitability for the intended purpose of
application by suitable performance tests in particular. RAUMEDIC shall not assume any explicit or
implicit warranty, guarantee or liability for the suitability for any purpose which exceeds the description of
the article in these instructions for use. This shall also apply for the further processing of this article and
for its use for the manufacture of other products. RAUMEDIC warranty terms shall apply exclusively.
These instructions for use shall be protected by copyright. The rights derived, in particular those in the
translation, reproduction, use of illustration, radio transmission, representation by photo-mechanical or
similar way and the storage in data processing systems, shall be reserved.
0123
This document is for information only