BD BodyGuard Small Lockbox Manual de usuario

BodyGuard™

Small Lockbox

170-250X

OPR00344 Rev. 00

EN - Directions for Use ...................................................... 1

DA - Brugsanvisning ...................................................... 7

DE - Gebrauchsanweisung ...................................................... 13

ES - Manual del usuario ...................................................... 20

FR - Mode d'emploi ...................................................... 27

GR - Οδηγίες χρήσης ...................................................... 34

IT - Istruzioni per l’uso ...................................................... 41

NL - Gebruiksaanwijzing ...................................................... 47

NO - Bruksanvisning ...................................................... 54

PL - Instrukcja obsługi ...................................................... 60

PT - Instruções de utilização ...................................................... 67

SV - Bruksanvisning ...................................................... 74

TR - Kullanım Talimatları ...................................................... 80

OPR00344 Rev. 00

EN- Directions for Use

Table of Contents

1. General Information 1

2. Compatibility 3

3. Use 3

4. Maintenance 5

1. General Information

The information in this document is subject to change and does not represent

a commitment on the part of Caesarea Medical Electronics Ltd. to provide

additional services or enhancements. Documentation provided with this

product might reference product not present in your facility or not yet

available for sale in your region.

1.1. Intended Use

The BDBodyGuard™ Small Lockbox (170-250X) (hereinafter referred to as

"Lockbox") is intended to avoid misuse of drug as deemed necessary, by

preventing unauthorized access to the BD BodyGuard™ Pump Systems

(hereinafter referred to as "Pumps") and medication while infusing under the

specified conditions. The Lockbox is intended to be used by healthcare

professionals and home users in professional healthcare facilities and home

healthcare environments, under the guidance of a healthcare professional.

1.2. Clinical Benefits

Uncontrolled boluses of critical drugs (for example, morphine) may cause

catastrophic harm to patients. The Lockbox enables users to safely protect the

drugs prepared in the infusion container from unauthorized removal or use.

1.3. Performance Characteristics

The Lockbox holds the compatible Pump, infusion containers, and accessories

(see section 2. Compatibility on page 3). The Lockbox prevents access to the

infusion container, infusion set (upstream of pumping segment), and Pump

door. It allows the user to view the Pump screen and access the Pump buttons.

1.4. Operating and Storage Conditions

The Lockbox has the same operating and storage conditions as the Pump it is

compatible with. Refer to the Pump Directions for Use for details.

OPR00344 Rev. 00 1

EN - Directions for Use

1.5. Warnings

Warning: Do not use the Lockbox if it is broken or damaged, replace it

with a new Lockbox.

Warning: Once the Lockbox is in use, make sure that the Lockbox key

remains accessible to avoid a delayed start of therapy. Make sure that

the key is secure to prevent unauthorized use, which could lead to

tampering with the infusion system.

Warning: Read this Directions For Use before using the Lockbox. Be

aware of the risks associated with incorrect use of the Lockbox.

Warning: Do not use the Lockbox if it has exceeded its operational

lifetime as outlined in this Directions For Use. If the lifetime of the

Lockbox has expired, replace it with a new Lockbox.

Warning: Do not place the Lockbox near heat sources and do not expose

it to direct sunlight for extended periods of time. This may result in

heating up and damage of the Lockbox.

Warning: Do not use the Lockbox containing the pump in MRI rooms

and do not expose it to environments with electromagnetic radiation.

1.6. Symbols

Symbol Description

General warning sign. Read the instructions for use for

important warnings and precautions that cannot be presented

on the medical device.

Consult instructions for use or consult the electronic instructions

for use. Electronic instructions can be viewed and downloaded

at www.eifu.bd.com. Check the website periodically for updates.

CE marking. Indicates that a device is in conformity with the

requirements set out in the applicable Union harmonization

legislation providing for its affixing.

Date of manufacture

2OPR00344 Rev. 00

EN - Directions for Use

Symbol Description

Manufacturer

Authorized representative in the European Community

Catalog number

Serial number

Batch number

2. Compatibility

2.1. Compatible Pumps

The Lockbox is compatible with the following infusion Pumps:

lBD BodyGuard™(CMEPump model BG323CV)

lBD BodyGuard™ Pain Manager (CMEPump model BG595CV)

lBD BodyGuard™ Epidural (CME Pump model BG545CV)

2.2. Compatible Infusion Containers

The Lockbox is compatible with collapsible infusion containers of up to 10 cm

length and 8 cm width.

2.3. Compatible Accessories

The Lockbox is compatible with the following accessories:

lBD BodyGuard™ Medium Pouch Blue (100-083A)

lBD BodyGuard™ Medium Pouch Yellow (150-250XE)

lBD BodyGuard™ Bolus Cable (140-100X)

lBD BodyGuard™ Bolus Cable with Light (140-400X)

lBD BodyGuard™ Wall Charger (999-WC)

3. Use

3.1. Description

The Lockbox attaches to the back of all BD BodyGuard™ Single-channel Pumps.

See OPR00335

OPR00344 Rev. 00 3

EN - Directions for Use

Front View Side View

1 Infusion container compartment 6 Infusion container compartment

2 Tab slot 7 Tab slot

3 Pump location 8 Pump location

4 Channel for routing the infusion set

tubing

9 Channel for routing the infusion set

tubing

5 Locking pin 10 Locking pin

3.2. Preparation

1. Visually inspect the Lockbox before setup. Do not use if there are any

damaged or broken parts.

2. Select the appropriate combination of infusion container and infusion set

for use with the Lockbox. Consider the following selection criteria:

lThe infusion container size when filled to required volume before

infusion.

lThe infusion set connector type attached to the infusion container.

lThe infusion set length.

Warning: Avoid compression of the infusion container.

Warning: Ensure that infusion sets fit correctly to avoid occlusion or

kinking of the tubing.

Warning: Ensure that the length of tubing is appropriate. Insufficient

length can lead to infusion set detachment. Excessive length can lead to

infusion set damage, set entanglement, and the risk of strangulation.

3. Connect the infusion set to the infusion container.

3.3. Loading the Lockbox

See OPR00335

1. Insert the infusion container into the Lockbox.

2. Line up the tabs on the side of the Pump with the tab slots on the Lockbox.

3. Route the infusion set tubing through the channel.

4. Press the Pump into the slot.

4OPR00344 Rev. 00

EN - Directions for Use

3.4. Securing the Lockbox

See OPR00335

Connect the bolus cable (optional) using the port on the side of the Pump and

connect the power cable (optional) to the Pump.

To secure the Pump in the Lockbox:

1. Push the key into the locking pin.

2. Turn the key clockwise until you meet resistance.

3. Ensure that the Pump is secured within the Lockbox.

Warning: When using the Lockbox without a Bag or Pouch, ensure that

the Lockbox remains in the correct orientation.

3.5. Unloading the Lockbox

See OPR00335

Disconnect the power cable (if connected) and bolus cable (if connected) from

the Pump.

1. To remove the Pump from the Lockbox, push the key into the locking pin,

turn in a counterclockwise direction, and lift the Pump out of the Lockbox.

2. Remove the infusion container.

4. Maintenance

4.1. Lifetime

The expected lifetime of the Lockbox is 12 months. The expected lifetime is

the period of time, estimated by BD, during which the Lockbox is expected to

maintain safe and effective use. Safe and expected use may not be achieved

after the expected lifetime. Do not attempt to repair the Lockbox if it is

damaged. Replace it with a new Lockbox.

4.2. Cleaning

It is recommended to clean the Lockbox in the following cases:

lBefore use on a patient.

lAt regular time intervals per healthcare facility procedure.

lWhen the surface is visibly soiled.

Caution: Do not use cleaning agents containing bleach/sodium

hypochlorite (for example, Clorox Healthcare, Sani-Cloth Plus).

To clean the Lockbox, do as follows:

OPR00344 Rev. 00 5

EN - Directions for Use

1. Turn off the Pump and disconnect from patient.

2. Disconnect all power cords and charger.

3. Remove all contents from the Lockbox.

4. Clean all internal and external surfaces of the Lockbox with non-abrasive,

lint-free wipe containing 70% isopropyl alcohol (IPA). Remove all visible

soils, paying special attention to hard-to-clean areas. Follow the cleaning

agent’s instructions for the required exposure time and removal of residue.

5. Clean the key with a disinfectant wipe.

6. Dry all surfaces with a non-abrasive, lint-free cloth.

4.3. Disposal

Used Pumps and Accessories should be cleaned following the instructions in

the Cleaning section and disposed of in accordance with local legislation.

4.4. Document History

Issue Date Description

00 Feb 2023 Initial release

6OPR00344 Rev. 00

EN - Directions for Use

DA- Brugsanvisning

DA - Indhold

1. Generel information 7

2. Kompatibilitet 9

3. Brug 10

4. Vedligeholdelse 11

1. Generel information

Oplysningerne i dette dokument kan ændres og repræsenterer ikke en

forpligtelse for Caesarea Medical Electronics Ltd. om at stille yderligere

tjenester eller forbedringer til rådighed. Den dokumentation, der leveres med

dette produkt, kan henvise til et produkt, der ikke findes på din facilitet eller

endnu ikke er markedsført i din region.

1.1. Tilsigtet anvendelse

BDBodyGuard™ Small Lockbox (170-250X) (i det følgende benævnt

"Låseboks") er beregnet til at undgå misbrug af lægemidler, hvis det skønnes

nødvendigt, ved at forhindre uautoriseret adgang til BD BodyGuard™

pumpesystemerne (i det følgende benævnt "Pumper") og medicin under

infusion under de angivne forhold. Låseboksen er beregnet til at blive brugt af

sundhedspersonale og hjemmebrugere i sundhedssektoren og

hjemmeplejemiljøer under vejledning af sundhedspersonale.

1.2. Kliniske fordele

Ukontrollerede bolusser af kritiske lægemidler (f.eks. morfin) kan forårsage

katastrofal skade på patienterne. Låseboksen gør det muligt for brugerne at

beskytte de lægemidler, der er klargjort i infusionsbeholderen, mod

uautoriseret fjernelse eller brug.

1.3. Funktionalitet

Låseboksen indeholder den kompatible pumpe, infusionsbeholdere og tilbehør

(se afsnittet se afsnittet 2. Kompatibilitet på side 9). Låseboksen forhindrer

adgang til infusionsbeholderen, infusionssættet (opstrøms for pumpesegment)

og pumpedøren. Den giver brugeren mulighed for at se pumpeskærmen og få

adgang til pumpeknapperne.

1.4. Drifts- og opbevaringsforhold

Låseboksen har de samme drifts- og opbevaringsforhold som den pumpe, den

er kompatibel med. Se pumpens Brugsanvisning for yderligere oplysninger.

OPR00344 Rev. 00 7

DA - Brugsanvisning

1.5. Advarsler

Advarsel: Brug ikke låseboksen, hvis den er ødelagt eller beskadiget.

Udskift den med en ny låseboks.

Advarsel: Når låseboksen er i brug, skal du sørge for, at låseboksnøglen

forbliver tilgængelig for at undgå forsinket start af behandlingen. Sørg

for, at nøglen er sikret mod uautoriseret brug, som kan føre til

manipulation af infusionssystemet.

Advarsel: Læs denne Brugsanvisning, før du bruger låseboksen. Vær

opmærksom på de risici, der er forbundet med forkert brug af

låseboksen.

Advarsel: Brug ikke låseboksen, hvis den har overskredet sin levetid som

beskrevet i denne Brugsanvisning. Hvis låseboksens levetid er udløbet,

skal den udskiftes med en ny låseboks.

Advarsel: Placer ikke låseboksen i nærheden af varmekilder, og udsæt den

ikke for direkte sollys i længere tid ad gangen. Dette kan medføre

opvarmning og beskadigelse af låseboksen.

Advarsel: Brug ikke låseboksen med pumpen indeni i MRI-rum, og udsæt

den ikke for miljøer med elektromagnetisk stråling.

1.6. Symboler

Symbol Beskrivelse

Generelt advarselsskilt. Læs brugsanvisningen for at få

kendskab til vigtige advarsler og forholdsregler, som ikke kan

præsenteres på det medicinske udstyr.

Se brugsanvisningen, eller se den elektroniske brugsanvisning.

Elektroniske instruktioner kan ses og downloades på

www.eifu.bd.com. Søg regelmæssigt på webstedet efter

opdateringer.

CE-mærkning. Angiver, at udstyr er i overensstemmelse med

kravene i den gældende EU-harmoniseringslovgivning, der

foreskriver påsætning af mærkatet.

8OPR00344 Rev. 00

DA - Brugsanvisning

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