Weinmann O2 Box Rescue compact Instructions For Use Manual

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O
Box Rescue compact
2
Oxygen supply unit
Instructions for use
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Table of Contents
1 Introduction 4
1.1 Intended use ................................................................................. 4
1.2 Function ........................................................................................ 4
1.3 Operator and user qualification ..................................................... 5
1.4 Contraindications .......................................................................... 5
1.5 Side effects ................................................................................... 5
2 Safety 6
2.1 Warnings in this document ............................................................ 6
2.2 Safety information ......................................................................... 7
2.3 General instructions ...................................................................... 8
3 Description 9
3.1 Overview ....................................................................................... 9
3.2 Labels and symbols ..................................................................... 10
4 Preparation and operation 11
4.1 Connecting the oxygen supply to the oxygen administrator .......... 11
4.2 Changing the oxygen cylinder ...................................................... 12
4.3 Removing the oxygen administrator ............................................. 13
4.4 Securing the oxygen administrator ............................................... 13
5 Hygienic reprocessing 14
5.1 General instructions .................................................................... 14
5.2 Intervals ...................................................................................... 14
5.3 Hygienic reprocessing of the device ............................................. 14
6 Function check 16
6.1 Intervals ...................................................................................... 16
6.2 Checking the box ........................................................................ 16
6.3 Checking the oxygen administrator .............................................. 17
6.4 Checking the fixation of the oxygen administrator ........................ 18
6.5 Checking the pressure reducer ..................................................... 18
7 Maintenance 19
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8 Storage 19 9 Disposal 19
10 Appendix 20
10.1 Technical data ............................................................................. 20
10.2 Scope of supply ........................................................................... 21
10.3 Warranty ..................................................................................... 23
10.4 Declaration of Conformity ............................................................ 23
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Introduction
1 Introduction
1.1 Intended use
The O2Box Rescue compact is used to transport an oxygen system and the required accessories. A maximum of 4 patients can be supplied with oxygen simultaneously on site. The O
Box Rescue compact is predominantly used at multiple
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casualty/victim accident scenes.
1.2 Function
The box is equipped for the transport of two 5 l oxygen cylinders. It is only ever possible to connect one pressure reducer to the removable oxygen administrator in the cover of the box.
You can ventilate up to 4 patients with a flow of 1 l/min to 15 l/ml using the oxygen cylinders in the box.
The connection hose supplied (5 m) has a DIN connector on one end and a Walther self-sealing adapter on the other.
The oxygen administrator offers the following connection options:
Walther coupling: connection of a central gas supply with DIN coupling
DIN coupling: connection to oxygen supply of external devices (e.g., MEDUMAT Standard
2
ventilator)
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Introduction
Operation with external devices
The box can be operated with external devices. Examples:
MEDUMAT Easy CPR
MEDUMAT Standard a
MEDUMAT Standard
MEDUMAT Transport
OXYMAND demand valve
OMNIVAC secretion suction
If all of the inhalation outlets and an external device are used simultaneously, there may be a reduction in the oxygen output volume (see “10.1.2 Output volume of the oxygen administrator”,
page21).
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1.3 Operator and user qualification
The box must only be used by persons who can verify that they have the following qualifications:
Medical qualification
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Training in ventilation techniques
Knowledge of the instructions for use for the devices used
1.4 Contraindications
There are no known contraindications.
1.5 Side effects
There are no known side effects.
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Safety
2 Safety
2.1 Warnings in this document
Warnings are used to flag up safety-relevant information.
You will find a warning preceding any action that entails a hazard for persons or equipment.
Warnings consist of
the warning symbol (pictogram),
a signal word designating the hazard level,
information about the hazard, and
instructions for avoiding the hazard.
The warnings appear in three hazard levels depending on the degree of danger:
Danger!
Designates an extremely dangerous situation. Failure to observe this warning will lead to serious, irreversible injury or death.
Warning!
Designates an extremely dangerous situation. Failure to observe this warning may lead to serious, irreversible or fatal injury.
Caution!
Designates a dangerous situation. Failure to observe this warning may lead to minor or moderately serious injury.
Notice!
Designates a risk of damage to equipment. Failure to observe this warning may lead to damage to equipment.
Designates useful information relating to a particular action.
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2.2 Safety information
Please read these instructions for use and the instructions for use for the devices in the box carefully. The instructions for use form part of the devices described, and must be available at all times.
Only use the box for the intended use (see “1.1 Intended use”,
page4).
For your own safety and that of your patients, and in accordance with the requirements of Directive 93/42/EEC, please observe the following safety instructions:
2.2.1 Safe use of the box
Risk of damage due to incorrect use!
Incorrect use may result in damage to the device.
Do not stack more than 5 boxes on top of each other. Do not place anything on top of the box. Do not sit or stand on the box.
Safety
2.2.2 Safe handling of oxygen
Risk of injury from oxygen input line!
Oxygen can accumulate in clothing, textiles, and hair. In combination with smoking, open flames, and electrical devices it may cause fires and explosions.
Do not smoke. Keep away from open flames. Do not use any hoses which conduct electricity. Keep the devices and screwed unions free from oil and grease. Wash your hands before using the devices. Pay attention to the expiry date of the oxygen cylinder. Tighten the screwed unions by hand to avoid damaging the
threads and seals.
Open the cylinder valve slowly to avoid pressure blows to the
fittings.
Do not empty the oxygen cylinder completely in order to
prevent the ingress of moisture.
Close the cylinder valve after use.
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Safety
Risk of injury from oxygen therapy!
Incorrect administration/dosage of oxygen therapy can result in side effects.
Only administer oxygen when prescribed by a physician. Observe the instructions for use of the oxygen system.
2.3 General instructions
Please observe the section on hygienic reprocessing in order to avoid infection or bacterial contamination (see “5 Hygienic
reprocessing”, page14).
Inspections and maintenance should only be carried out by the manufacturer, WEINMANN Emergency.
If third-party items are used, malfunctions may occur and fitness for use may be restricted. Biocompatibility requirements may also not be met. Please note that in such cases, any warranty claim and liability will be voided if neither the accessories recommended in the instructions for use nor genuine replacement parts are used.
This product may contain disposable items. Disposable items are intended to be used only once. So use these items only once and do not reprocess them. Reprocessing disposable items may impair the functionality and safety of the product and lead to unforeseeable reactions as a result of ageing, embrittlement, wear, thermal load, the effects of chemical processes, etc.
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3 Description
1
1011
2
9
5
4
3
6
7
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3.1 Overview
Description
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No. Designation Description
1 Handle Enables the box to be carried.
The pressure hose has a DIN connector and a self-sealing adapter for the Walther
2 Pressure hose, 5 m
coupling. It connects the oxygen administrator to the central gas supply or an external device (see “1.2 Function”,
page4).
The removable oxygen administrator has 4adjustable locking inhalation outlets, a
3 Oxygen administrator
Walther coupling, and a DIN coupling. The oxygen administrator is secured to holding brackets in the cover of the box using equipment rail adapters.
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Description
.
No. Designation Description
The pressure hose has a G 3/8" screw connector and a self-sealing adapter for
4 Pressure hose, 1 m
the Walther coupling. It connects the oxygen administrator to the oxygen cylinder.
5 Clamping belt Keeps the oxygen cylinder in its position.
6 Oxygen cylinder
7 Pressure reducers
8
T-distributor with check valve
The box has space for two 5 l oxygen cylinders.
The pressure reducers release oxygen at reduced pressure.
For connecting the oxygen administrator to the oxygen cylinder using a Walther connector.
9 Cover holder Holds the cover of the box open.
10 Slot Contains the label of the box. 11 Lock Keeps the box locked.
3.2 Labels and symbols
Symbol Meaning Device information label
Year of manufacture
SN Serial number
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CE mark (confirms that the product complies with the applicable European directives)
Consult instructions for use.
Gas type: O
2
Operating pressure range 2.7 bar - 6 bar
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4 Preparation and operation
Risk of injury from highly compressed oxygen!
When combined with highly compressed oxygen, hydrocarbon compounds can cause explosions.
Wash your hands before changing the oxygen cylinder. Do not use any oil, grease, cleaning alcohols, hand cream, or
adhesive plasters.
Do not use tools to loosen or tighten the union nuts.
4.1 Connecting the oxygen supply to the oxygen administrator
Preparation and operation
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1. Connect the pressure hose’s threaded connection to the free
threaded connection on the oxygen administrator.
2. Connect the pressure hose’s self-sealing adapter to the
pressure reducer’s Walther coupling.
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Preparation and operation
3. Open the oxygen cylinders.
Result The oxygen supply has been connected and the box is ready for
use.
4.2 Changing the oxygen cylinder
1. Close the valve on the oxygen cylinder.
2. Open a dosage unit until the system is depressurized.
3. Remove the pressure hose from the pressure reducer.
4. Open the clamping belt on the oxygen cylinder.
5. Remove the oxygen cylinder from the box.
6. Disconnect the pressure reducer.
Risk of injury from flying particles of dust!
When opening the oxygen cylinder, flying particles of dust may get into the eyes. Never aim the cylinder towards people when opening it.
7. Briefly open the valve of the new oxygen cylinder in order to blow away any particles of dust.
8. Connect a pressure reducer to the valve of the new oxygen cylinder using the knurled union nut.
9. Insert the oxygen cylinder in the box.
10. Tighten the clamping belt on the oxygen cylinder.
11. Reconnect the pressure hose.
Result The oxygen cylinder has been changed.
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Preparation and operation
4.3 Removing the oxygen administrator
1. Push the locking levers downwards until the locking
mechanism disengages.
2. Lever the oxygen administrator upwards out of the holding
brackets.
Result The oxygen administrator is no longer secured in the cover.
4.4 Securing the oxygen administrator
1. Insert the oxygen administrator in the lower holding bracket.
2. Hook the oxygen administrator into the upper holding bracket
using the equipment rail adapters.
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Result The oxygen administrator is secured in the cover. The locking levers
3. Push the locking levers outwards until the locking mechanism
noticeably snaps into place.
are parallel to the oxygen administrator.
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Hygienic reprocessing
5 Hygienic reprocessing
5.1 General instructions
Use suitable gloves for disinfection work (e.g., household or disposable gloves).
Please refer to the instructions for use supplied with the disinfectant used.
Recommendation: terralin
®
protect for wipe disinfection
5.2 Intervals
Reprocess the device hygienically after every use.
5.3 Hygienic reprocessing of the device
Risk of explosion if disinfectants containing alcohol or grease are used for wipe disinfection!
Disinfectants containing alcohol or grease react with oxygen to create a flammable mixture and can result in explosions and injury to the user and patient. When wiping the pressure reducer and the oxygen
administrator with disinfectant, do not use disinfectants containing alcohol or grease.
Risk of injury due to ingress of liquids!
Liquids entering the oxygen administrator and pressure hoses (e.g., disinfectants) can injure the patient and damage components. Never immerse components in liquids. Wipe them down
1. Remove the oxygen cylinders from the box.
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carefully with a moist cloth.
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Hygienic reprocessing
2. Carry out hygienic reprocessing of the box as specified in the
following table:
Part Cleaning Disinfection Sterilization
Metal surfaces of the box
Foam
Oxygen administrator
Wipe down with a moist cloth
Wipe down with a moist cloth
Wipe down with a moist cloth
Wipe disinfection Not permitted
Wipe disinfection Not permitted
Wipe disinfection Not permitted
With a dry or moist
Oxygen cylinders
cloth: use clean
Wipe disinfection Not permitted
water
Pressure hoses
Wipe down with a moist cloth.
Wipe disinfection Not permitted
With a dry or moist
Pressure reducers
cloth: use clean
Wipe disinfection Not permitted
water
3. Insert the oxygen cylinders in the box.
4. Perform a function check (see “6 Function check”, page16).
Result The box has been hygienically reprocessed.
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Function check
6 Function check
6.1 Intervals
Carry out a function check at the following intervals:
Before each use
After each disassembly
Every 6 months
6.2 Checking the box
1. Carry out a visual inspection.
Requirement:
The corners and handle are undamaged.
The locks can be opened easily.
The hinges open smoothly and are correctly attached.
The foam is not impaired in its function.
The cover holder is undamaged and the hinge of the cover
holder opens smoothly.
The cover holder clicks into both positions (on the box and
on the cover) securely.
2. If one of the requirements is not fulfilled: replace defective components or send the box to the manufacturer, WEINMANN Emergency, for repair.
Result The box has been checked.
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Function check
6.3 Checking the oxygen administrator
Risk of injury from damaged oxygen administrator!
A damaged oxygen administrator does not provide sufficient oxygen for ventilation. This can injure the patient. Only use the box if all the locking buttons on the oxygen
administrator are undamaged.
1. Check the oxygen administrator for visible mechanical
damage.
2. To check the flow: connect the oxygen administrator with the
pressure hose to the pressure reducer of an oxygen cylinder.
3. Set all the locking buttons on the oxygen administrator to 0.
The valves on the oxygen administrator and thus the system behind the pressure reducer are blocked.
4. Check that the screwed unions and hose connections are
secure.
5. If necessary: tighten the screwed unions by hand.
6. Open the valve of the oxygen cylinder slowly.
7. Read off the cylinder pressure on the contents gauge of the
pressure reducer.
Cylinder pressure = 200 bar: oxygen cylinder is full Cylinder pressure = 100 bar: oxygen cylinder is half-full
8. When cylinder pressure is <
cylinder.
9. Use the locking buttons to set all of the locking positions in
succession.
Requirement: The flow at the oxygen outlet must increase as per the locking position (increasing hissing noise).
50 bar: change the oxygen
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10. To check for leaks: set all the locking buttons to 0.
The oxygen administrator is not a shut-off valve. The only way to prevent oxygen from escaping from the system is to keep the valve on the oxygen cylinder closed.
11. Close the valve on the oxygen cylinder.
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Function check
12. Watch the needle on the contents gauge of the pressure reducer for approx. 1 minute.
Requirement: The needle must remain still.
13. Set a locking button to 0 until the system is depressurized.
14. If a requirement is not fulfilled: contact WEINMANN Emergency or a technician authorized by WEINMANN Emergency.
Result The oxygen administrator has been checked.
6.4 Checking the fixation of the oxygen administrator
1. Insert the oxygen administrator in the cover of the box.
2. Push the locking levers outwards until the locking mechanism
3. If the locking levers do not function perfectly: replace the
Result The fixation has been checked.
6.5 Checking the pressure reducer
Observe the instructions for use of the OXYWAY pressure reducer.
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noticeably snaps into place.
Requirement: It must not be possible to move the oxygen administrator.
equipment rail adapters.
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7 Maintenance
The box is maintenance-free. However, please observe the following points:
A check measurement of the oxygen administrator should be performed every four years to verify the dosage accuracy. When doing so, observe the instructions for use of the OXYWAY Click oxygen administrator.
Observe the instructions for use of the OXYWAY pressure reducer.
8Storage
Maintenance
9 Disposal
Observe the permissible ambient conditions (see “10.1.1 Technical
data for box”, page20).
Do not dispose of the box in the household waste. Consult an authorized, certified waste disposal company for proper disposal. You can find out their address from your environmental officer or from your local council.
The device packaging (cardboard and inserts) can be disposed of as waste paper.
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Appendix
10 Appendix
10.1 Technical data
10.1.1 Technical data for box
Specification Box
Product class according to 93/42/EEC I External measurements
(W x H x D in mm) Internal measurements
(W x H x D in mm) Weight
Without oxygen cylinder and oxygen administrator
With oxygen cylinder and oxygen administrator
Temperature range
Operation
Storage
Permissible humidity for storage Max. 95% relative humidity Standards used AECTP 400:2006
615 x 420 x 270
570 x 380 x 220
Approx. 10 kg
Approx. 31 kg
-18°C to +60°C
-40°C to +70°C
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Subject to alterations in design
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Appendix
10.1.2 Output volume of the oxygen administrator
The output of the individual inhalation outlets may fluctuate according to utilization of the administrator. The values listed in the following table presuppose that a pressure reducer with an output of at least 190 l/min is used.
Tolerances for the set flow per inhalation outlet in l/min 12345691015
Max. 2 outlets open ±0.5 ±0.5 ±0.5 ±0.5 ±0.5 -0.5 -0.5 -0.5 -0.5 Max. 4 outlets open ±0.5 ±0.5 ±0.5 ±0.5 ±0.5 -1.0 -1.0 -1.5 -2.5 Max. 4 outlets open +
external unit
10.2 Scope of supply
10.2.1 Standard product
±0.5 -0.5 -0.5 -1.0 -1.0 -1.0 -1.5 -2.5 -3.5
All values determined under ATP conditions.
Part Article number O
Box Rescue compact, installed with: WM 9515
2
Removable OXYWAY Click oxygen administrator WM 3804 Pressure reducer for oxygen WM 30301 T-distributor with check valve WM 8220 Pressure hose, 1 m, white, with G 3/8" and connector
for Walther quick-release oxygen coupling Pressure hose, 5 m, with quick-release coupling as per
DIN 13260 and Walther quick-release oxygen coupling Inhalation mask, plastic, with hose (4 pieces) WM 1429 Accessory case (2 pieces) WM 9026
Box Rescue compact instructions for use EN WM 66421
O
2
You can also order all the items listed here as spare parts.
WM 9535
WM 9545
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Appendix
10.2.2 Spare parts
Part Order number
Holding plate for oxygen cylinders WM 9516 Holding plate for OXYWAY Click oxygen administrator WM 9524 Edge protector, 90 mm WM 3819 Edge protector, 180 mm WM 8104 Adapter for equipment rail WM 8244 Holder for equipment rail adapter WM 3805 Adapter with G 3/8" internal thread and Walther quick-
release oxygen coupling Connection nozzle with union nut, diameter 6.7 mm,
G 3/8" T-distributor with check valve, outlet G 3/8", inlet self-
sealing coupling (Walther) Cap for G 3/8" external thread WM 1231 Countersunk fillister head screw, M4 x 10 with Tuflok-
Fleck Countersunk fillister head screw, M4 x 10 WM 51399 Countersunk fillister head screw, M5 x 16 WM 51420 Hexagon nut M5 WM 50924 Protective disk, diameter 4 mm WM 3566 Protective disk, diameter 5 mm WM 3567
WM 1485
WM 1415
WM 8220
WM 51397
Please also see the replacement parts listed in the instructions for use for the devices.
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10.3 Warranty
Starting from the date of purchase, WEINMANN Emergency offers the customer a limited manufacturer’s warranty on a new original WEINMANN Emergency product or replacement parts installed by WEINMANN Emergency in accordance with applicable warranty terms and conditions for the particular product and the warranty periods listed below. The warranty terms and conditions are available on the Internet at www.weinmann-emergency.de. On request, we will send you the warranty terms and conditions by mail.
If you wish to make a warranty claim, consult your authorized dealer.
Product Warranty periods
WEINMANN Emergency devices, incl. accessories (excluding: masks) for oxygen therapy and emergency medicine
Appendix
2years
Masks, incl. accessories, batteries (unless otherwise stated in the technical documentation), sensors, hose systems
Disposable products None
6months
10.4 Declaration of Conformity
WEINMANN Emergency Medical Technology GmbH + Co. KG declares herewith that the product complies fully with the respective regulations of the Medical Device Directive 93/42/EEC.
The unabridged text of the Declaration of Conformity can be found on our website at www.weinmann-emergency.de
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WEINMANN Emergency Medical Technology GmbH + Co. KG
Frohboesestrasse 12 22525 Hamburg GERMANY E: customerservice@weinmann-emt.de www.weinmann-emergency.de T: +49 40 88 18 96-120 F: +49 40 88 18 96-481
Center for Production, Logistics, Service
WEINMANN Emergency Medical Technology GmbH + Co. KG Siebenstuecken 14 24558 Henstedt-Ulzburg GERMANY
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medical technology
made in germany
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