INDEX
1
INTENDED USE ···························································································································
1
SPECIFICATIONS ·························································································································
1
PART NAMES ······························································································································
2
SAFETY PRECAUTIONS ···············································································································
3 – 6
INSTALLATION ····························································································································
7
UNPACKING AND CHECKING PARTS ·····························································································
7
DEFINITION OF SYMBOLS ············································································································
8
OPERATION ································································································································
9 – 10
SUITABLE PRODUCT ···················································································································
10
DAILY MAINTENANCE ··················································································································
11 – 12
REGULAR INSPECTION AND MAINTENANCE ·················································································
13
LONG-TERM STORAGE ················································································································
13
AFTER-SALES SERVICE ···············································································································
14
INTENDED USE
This cart is a hospital bassinet that is designed to be used for caring for and supporting newborns and newborn
patients in medical institutions, and providing newborns with comfort, quality care, and efficient treatment.
* For details of the patient target groups, the intended users and the clinical benefits, see
“
SPECIFICATIONS
”
p.1.
* For details of the contra-indications, see
“
PROHIBITED
”
p.5.
* Frequently used functions: Adjusting the inclination of the basket, adjusting the height of the basket.
SPECIFICATIONS
Product name
Bassinet cart
Bassinet cart
(with height adjustable function)
Japan Medical Device Registration Number
12B1X10020000102
12B1X10020000103
Model No.
KB-115EG
KB-116EG
Dimensions
530 mm × 862 mm × 920 mm
(Width × Length × Height)
530 mm × 862 mm × 810 mm to 1060 mm
(Width × Length × Height)
Product weight
17 kg
22 kg
Inclination angle
0
°
to 12
°
Operating principles
Manual operated incline mechanism of newborn support basket, using a free lock gas spring
Materials
Plastic basket
ABS resin
Mattress
Padding: Urethane foam, External cover: Polyester
Basket holder grip
Leg cover basket
Polypropylene
Hand-rest cover
-
Ethylene-propylene rubber
Lever end
Ethylene-propylene rubber
Name holder
Holder: Polypropylene and Ethylene vinyl acetate copolymer
Sucker: styrene-ethylene-butylene-styrene block copolymer
Frame
Made of steel, electrocoating/powder coating
Support bar
Aluminum/alumite treatment
Caster diameter
100 mm double wheel caster with stopper
Load capacity
Plastic basket: 7 kgf (68.6 N), Leg pocket (one side): 3 kgf (29.4 N)
Service life
8 years (based on Paramount data), excluding consumable items such as casters
Patient target groups
Infant weighting 7 kg or less
Intended users
Health care workers
Suitable product
Shade Cover (KB-P118SE)
Weight for each part
Main unit (without height adjustable function)
15 kg
Main unit (with height adjustable function)
20 kg
Plastic basket (include Mattress & Name Holder)
2 kg
Environmental conditions
Range
■
When transported stored
■
When in use
Temperature
-10
℃
to 50
℃
10
℃
to 40
℃
Humidity
30%RH to 90%RH
30%RH to 75%RH
Air pressure
700hPa to 1060hPa
700hPa to 1060hPa
Note:
The size of name card is under A6 (105 mm x 148 mm)
Classification and Standards
The cart is designed and manufactured according to the following equipment classification and standards.
Safety standards applied; IEC60601-1:2005 + A1:2012
EN60601-1:2006 + A1:2013
Classification as medical device in Europe: Class I
Equipment no suitable for use in the presence of a flammable anaesthetic mixture.
Essential performance: Supporting newborn infants.
Clinical benefit:
Newborn comfort
Quality newborn care and efficient care provision
